House of Lords London

European Union Committee SW1A 0PW www.parliament.uk/hleug

The primary purpose of the House of Lords European Union Select Committee is to scrutinise EU law in draft before the Government take a position on it in the EU Council of Ministers. This scrutiny is frequently carried out through correspondence with Ministers. Such correspondence, including Ministerial replies and other materials, is published where appropriate.

This edition includes correspondence from December 2009 to May 2010.

SOCIAL POLICY AND CONSUMER AFFAIRS (SUB-COMMITTEE G)

CONTENTS CONSUMER RIGHTS (14183/08) ...... 2 CROSS-BORDER BUSINESS TO CONSUMER E-COMMERCE IN THE EU (15058/09) ...... 2 CROSS-BORDER HEALTHCARE: APPLICATION OF PATIENTS’ RIGHTS (11307/08) ...... 4 DISEASES: EARLY WARNING AND RESPONSE SYSTEM (EWRS) FOR EPIDEMIOLOGICAL SURVEILLANCE (10148/09) ...... 5 DWP PRIORITIES DURING THE SPANISH PRESIDENCY ...... 5 EMPLOYMENT: JOINT EMPLOYMENT REPORT 2009/10 (5037/10) ...... 7 EQUAL OPPORTUNITIES: RIGHTS OF PERSONS WITH DISABILITIES (12892/08) ...... 7 EQUAL TREATMENT BETWEEN MEN AND WOMEN ENGAGED IN AN ACTIVITY IN A SELF- EMPLOYED CAPACITY (13981/08) ...... 7 EQUAL TREATMENT BETWEEN PERSONS IRRESPECTIVE OF RELIGION OR BELIEF, DISABILITY, AGE OR SEXUAL ORIENTATION (11531/08) ...... 8 EUROPEAN SOCIAL FUND: VOCATIONAL TRAINING ACTIONS FOR WOMEN (6066/10) ...... 12 FOOD INFORMATION TO CONSUMERS (6172/08) ...... 12 HEALTH: MEDICINAL PRODUCTS FOR HUMAN USE ...... 14 HEALTH AND SAFETY: PREVENTION OF SHARPS INJURIES IN THE HOSPITAL AND HEALTHCARE SECTOR (15305/09) ...... 14 HIV AND AIDS IN THE EU AND NEIGHBOURING COUNTRIES (15204/09) ...... 18 INFORMAL HEALTH COUNCIL 2010 ...... 19 ORGAN DONATION AND TRANSPLANTATION (16521/08, 16545/08) ...... 20 PARENTAL LEAVE (12761/09) ...... 23 PHARMACOVIGILANCE: PHARMACOVIGILANCE OF MEDICINAL PRODUCTS (17501/08, 17502/08) ...... 24 PHARMACOVIGILANCE: FALSIFIED MEDICINAL PRODUCTS (17504/08) ...... 25 SEASONAL INFLUENZA VACCINATION (11970/09) ...... 27 SOLIDARITY IN HEALTH: REDUCING HEALTH INEQUALITIES IN THE EU (14848/09) ...... 28 SPORTS POLICY ...... 29 WORKING TIME: ROAD TRANSPORT WORKING TIME ...... 31 YOUNG PEOPLE: PROMOTING LEARNING AND MOBILITY (11968/09) ...... 32 [Type text]

CONSUMER RIGHTS (14183/08)

Letter from Kevin Brennan MP, Minister of State, Department for Business, Innovation and Skills, to the Chairman I am writing to inform you of progress in the negotiation of the proposed Consumer Rights Directive which you have retained under scrutiny following your Report and debate on the Directive. The negotiations both in Council and the European Parliament are ongoing but progress remains slow. I participated in a policy debate on the Directive at Competitiveness Council in December of last year. During the debate I expressed my support for the Directive and for full harmonisation, where evidence shows that the current divergence of laws is creating barriers to trade. I stressed, however, that this must not be at the expense of key consumer protections, such as the right to reject faulty goods in the UK, and made clear that amendments are necessary before the UK will be able to agree the text. Whilst it was clear that the majority of Member States are supportive of the proposal for a new Directive and are keen to make progress, many of them share our strong concerns that the proposal as drafted would result in a reduction in consumer protection. Progress was made during Council Working Group meetings under the Swedish Presidency during the latter half of 2009. I am pleased to say that certain key UK concerns have been addressed in recent Presidency redrafts, including the insertion of provisions on the right to reject, exclusion of financial services from Chapter 3 of the proposal (on information and withdrawal rights for distance and off premises contracts) and amendments to the provisions on off-premises selling. However, these areas still need improvement and there are other areas where I feel that amendments are necessary before the text is acceptable to the UK. Negotiations are continuing under the Spanish Presidency and a policy debate on the Directive is scheduled for Competitiveness Council in May. In the European Parliament the Internal Market and Consumer Protection Committee (IMCO) have been considering the proposal. The Rapporteur is due to produce his report on the Directive in early May, with the Committee vote scheduled for the end of September. The Legal Affairs and Economic and Monetary Affairs Committees are expected to provide opinions on the proposal. It is intended that the First Reading Plenary vote in Parliament will take place in November of this year. Initial indications suggest that the IMCO Committee share the concerns of some Member States that full harmonisation would lead to a reduction in levels of consumer protection. They are therefore unlikely to support full harmonisation of the whole Directive and are likely to propose a mix of full and minimum harmonisation provisions. When the new Commission was appointed earlier this year responsibility for consumer contract and marketing law, including the Consumer Rights Directive, was split from the rest of the consumer portfolio in DG Health and Consumers and now comes under the remit of Commissioner Reding at DG Justice, Freedom and Security. It is too early to say whether this will have any significant impact on the Directive but Commissioner Reding has made clear that she sees legislative agreement on this Directive as a priority. 17 March 2010

CROSS-BORDER BUSINESS TO CONSUMER E-COMMERCE IN THE EU (15058/09)

Letter from the Chairman to Kevin Brennan MP, Minister of State, Department for Business, Innovation and Skills Your Explanatory Memorandum (EM) on the above Communication was considered by Sub- Committee G at its meeting of 10 December 2009. We consider that the objective of improving the regulatory environment for both consumers and traders in order to assist cross-border business to consumer e-commerce is very important. Nevertheless, we consider that other factors may also present a barrier to cross-border e- commerce, for example language differences and distance of delivery. [Type text]

The Commission’s document amounts largely to a compilation of actions that are already underway, including draft legislation currently awaiting decisions by the Council and/or European Parliament. This extends to the Consumer Rights Directive, on which we undertook an inquiry. We would remind you of the importance that we place on successful negotiation of a Directive which delivers a real business-to-consumer internal market with the consumer at its heart. Of those initiatives which will require further details from the Commission in due course, we would be interested in your view on how the Commission might be able to encourage industry involvement through greater uptake of the .eu domain name, pan-EU websites and improved search engines. Finally, you report that there is no need for an analysis of subsidiarity because the Communication is not a legislative measure. This is not necessarily the case as policy initiatives contained within a non- legislative document may infringe the principle of subsidiarity. In this instance, the proposed actions tackle a demonstrably cross-border activity, which could not be tackled as successfully by Member States acting alone. We would nevertheless remind you that Parliament requires from Government a more comprehensive analysis of such a document’s compliance with the principle of subsidiarity. We are content to release the Communication from scrutiny and look forward to your comments on the issues highlighted above. 10 December 2009

Letter from Kevin Brennan MP to the Chairman Thank you for your letter of 10 December 2009 on the Explanatory Memorandum on the above communication from the Commission. We agree that improving the regulatory environment to assist cross-border business to consumer e- commerce within the EU is important and support appropriate action to tackle regulatory barriers. We also agree that other factors such as language, currency, cultural variation and unfamiliar brands can all act as barriers to cross-border e-commerce, but we believe that addressing regulatory barriers is likely to contribute to increasing cross-border e-commerce and improve the functioning of the business to consumer internal market. We have noted the recommendations in your report on the Consumer Rights Directive and the need for us to undertake successful negotiation of a Directive which delivers real internal market benefits whilst providing a high level of consumer protection. We are working with the Commission and other Member States to agree amendments to the Directive which will enhance consumer protection in key areas such as the right to reject faulty goods and extending the period of trader liability, whilst ensuring that businesses do not face unnecessary and disproportionate burdens. Negotiations on the Directive are continuing in Council Working Group and the Internal Market and Consumer Affairs (IMCO) Committee of the European Parliament have indicated that their intention is for a first reading in November 2010. You ask how we think the Commission might be able to encourage industry to improve cross-border business by adopting .eu domain names and creating pan-EU websites. You also ask how the Commission's ideas on the role of search engines and comparison websites might be delivered. The Commission has had a programme to promote the use of .eu since the domain came into effect. While this has had a significant impact in terms of .eu registrations, it remains true that it does not remain the domain of choice for the larger online retailers. We will continue to engage with the Commission on ideas to further expand the use of .eu although we do not know at this stage what they will propose. In doing so, we will not wish to suggest that the use of .uk domains will inspire less confidence but we will accept that the greater visibility of .eu might help consumers overcome barriers to purchasing across borders. We have assumed that the Commission will engage in bilateral discussions with the leading search engines and price comparison websites to see if their methods can be adapted to more clearly identify cross-border opportunities. This has to be a matter of conjecture at this stage but we can support efforts to address the real need for online businesses to be ready to market goods and services across borders. We will press the Commission to discuss with industry how best to promote it. I take your point that the principle of subsidiarity goes wider than legislative measures and includes actions of Union institutions. As you note in your letter of 10 December the Commission’s Communication is largely references to other policies already underway, in relation to which of course we have or would expect to undertake a thorough analysis of compliance with the principle of subsidiarity. Nevertheless, we will pay great attention to assessing for subsidiarity any proposed action of the European institutions in future. [Type text]

We will be following up on a range of matters relating to cross-border e-commerce with the relevant Commission officials in the near future. This is an area where the European Union should be able to add real value. We hope that the involvement of former Competition Commissioner Kroes will give further impetus to Commission activity and we will be looking to meet with her officials and those of DG Markt and DG Sanco at the earliest opportunity to ensure that the Commission makes cross- border e-commerce a real priority in the next couple of years. We will consider inviting relevant Commission officials to London to meet UK-based e-tailers, to take views from industry about what would really help. 29 January 2010

CROSS-BORDER HEALTHCARE: APPLICATION OF PATIENTS’ RIGHTS (11307/08)

Letter from Gillian Merron MP, Minister of State, Department of Health, to the Chairman I am writing to update you on the outcome of discussions of the above proposal at the EPSCO meeting on 1 December, where I represented the UK. My letter of the 19 November explained my desire to support political agreement of the Swedish Presidency’s compromise text. Unfortunately, as I am sure you are now aware, the Council was not able to reach agreement on the text. There were intense discussions during the meeting about the inclusion of private and non-contracted providers in the scope of the Directive. I, along with the Presidency, Commission and the majority of Member States, argued that the rulings of the European Court of Justice made it clear that we could not use a Directive to exclude certain types of providers from cross-border healthcare. However, a minority of Member States refused to accept this argument, and blocked the agreement of the compromise text. I was disappointed by this outcome as my officials and I had worked hard during negotiations to ensure that the compromise text was favourable to the UK. I am also concerned that momentum on this issue may stall, and that little progress will be made in the near future. However, my officials and I will continue to fully engage on this issue and work to resolve the outstanding disagreements in Council. I look forward to hearing the Spanish Minister’s plans to take forward the Directive under their Presidency. I will of course update you on any significant developments. Thank you again for your continued interest and support on this issue. 14 December 2009

Letter from the Chairman to Gillian Merron MP Your letters of 19 November and 14 December on the above Proposal were considered by Sub- Committee G at its meeting of 7 January 2010. We share your disappointment that the Council failed to reach agreement on the dossier at its 1 December meeting and your scepticism that progress will be possible in the near future. Nevertheless, we suspect that there may be pressure from the European Parliament to kick-start negotiations and we would encourage you to continue your work with MEPs and with the Spanish Presidency to make some progress. We look forward to an update from you on any significant developments. 7 January 2010 [Type text]

DISEASES: EARLY WARNING AND RESPONSE SYSTEM (EWRS) FOR EPIDEMIOLOGICAL SURVEILLANCE (10148/09)

Letter from Gillian Merron MP, Minister of State, Department of Health, to the Chairman In your letter of the 2 July, you asked when the shorter term measures to strengthen contact tracing for public health purposes mentioned in the above report will be proposed. I wrote to you in early October to let you know that we were awaiting clarification on this from ECDC which has now been received. I apologise for not updating you sooner. The shorter term measures relate to a Commission Decision adopted on 10 July (OJ L 181, 14.7.2009, p57). This added a new functionality to the EWRS to promote information sharing for contact tracing. EU Member State Public Health Authorities can use this tool to securely exchange data (including personal information, travel details, contacts, accompanying person details and emergency contact information) to facilitate contact tracing activities. An example of when this might be used is to trace contacts of an individual with open tuberculosis who travelled on an international flight. Only those Member States involved in a contact-tracing investigation will be able to access the relevant data, and yearly analytical reports of usage of the system will be produced. Details of the Commission Decision are published in the Official Journal of the European Union and are available at: http://eurlex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2009:181:0057:0060:EN:PDF. As I said in my previous letter, the Commission will be reviewing the legislation on communicable diseases in 2010. 17 December 2009

DWP PRIORITIES DURING THE SPANISH PRESIDENCY

Letter from Angela Eagle MP, Minister of State, Department for Work and Pensions, to the Chairman Now that the Spanish Presidency of the EU is underway and it is clearer what business the Presidency is expecting to take forward, I would like to update you on my Department’s plans and priorities over the coming months. This letter sets out the key dossiers that will be progressed. The main focus of the Presidency for our departmental business will be to reduce the effect of the financial crisis on labour markets and its negative social effects, giving special attention to the most vulnerable. Their official Work Programme has now been published and can be found at: http://www.eu2010.es/export/sites/presidencia/comun/descargas/unioneuropea/Consejo_EPSCO_en.p df In the areas of employment and social policy, the Spanish Presidency’s overarching priority will be agreement on EU2020, the follow up to the Lisbon strategy. We expect proposals on this shortly from the new Commission, including on the Presidency themes of promoting quality jobs and combating youth unemployment. This will form the agenda of the Informal Meeting of Ministers of Employment and Social Security, which takes place in Barcelona on 28-29 January 2010. I will report to you more fully on the outcomes of the Informal after the event. There are two Employment, Social Policy, Health and Consumer Affairs (EPSCO) Councils scheduled to take place during the Presidency. These will be held on 8-9 March in Brussels and 7-8 June in Luxembourg. Although the Presidency has issued provisional agendas for these meetings, the content is likely to change during the run up to each Council. Officials will provide your Committee with annotated agendas and I will make the usual written statement in advance of, and report following, each Council meeting to set out the finalised outcomes that the Presidency will be aiming for, and how these fit with UK objectives.

DRAFT EPSCO AGENDA – MARCH 2010 The following items are provisionally listed for adoption/political agreement at the March Council: [Type text]

— Proposal for a Council Directive implementing the Framework Agreement on prevention from sharp injuries in the hospital and healthcare sector concluded by HOSPEEM and EPSU — Preparation of the Spring European Council a) Joint Employment Report 2009/2010 b) Joint Report on Social Protection and Social Inclusion 2010 Possible additions for adoption/political agreement are the linked: — Proposal for a Decision of the European Parliament and of the Council establishing a European Microfinance Facility for Employment and Social Inclusion (Progress Microfinance Facility) and — Proposal for a Decision of the European Parliament and of the Council amending Decision No 1672/2006/EC of the European Parliament and of the Council establishing a Community Programme for Employment and Social Solidarity.

DRAFT EPSCO AGENDA – JUNE 2010 The subjects provisionally listed for adoption/political agreement at the June Council, are the: — Proposal for a Council Decision on Guidelines for the Employment Policies of the Member States — Proposal for a Council Decision on the position to be taken by the Community within the Association Councils established by the Agreements with Algeria, Morocco, Tunisia, Croatia, the Former Yugoslav Republic of Macedonia and Israel with regard to the adoption of provisions on the co-ordination of social security systems. Possible additions for adoption/political agreement are the: — Proposal for a Directive amending Council Directive 92/85/EEC on the introduction of measures to encourage improvements in the safety and health at work of pregnant workers and workers who have recently given birth or are breastfeeding — Proposal for a Council Regulation extending the provisions of Regulation (EC) No 883/2004 and Regulation (EC) No […] to nationals of third countries who are not already covered by these provisions solely on the ground of their nationality — Proposal for a Council Directive on implementing the principle of equal treatment between persons irrespective of religion or belief, disability, age or sexual orientation. We also expect that Council Conclusions will be agreed in March on Gender-based violence, and that this will also be subject to a policy debate. In June, we expect that Council Conclusions will be agreed on; — Sustainability and adequacy of social security systems, pension schemes and inclusion — New Skills for New Jobs for a more competitive Europe — Active inclusion — Healthy and dignified ageing — Inclusion of Roma — European Disability Strategy We are broadly happy with the way the Spanish Presidency plan to take forward negotiations on these existing dossiers, and I look forward to continuing to work closely with your Committee to achieve the necessary scrutiny clearance before any agreement at Council. [Type text]

I hope you find this information helpful, and I will keep you informed of developments in preparation for the Councils in March and June. 25 January 2010

EMPLOYMENT: JOINT EMPLOYMENT REPORT 2009/10 (5037/10)

Letter from the Chairman to Angela Eagle MP, Minister of State, Department for Work and Pensions Your Explanatory Memorandum (EM) on the Joint Employment Report dated 20 January 2010 was considered by Sub-Committee G at its meeting of 25 February 2010. We found the Draft Report very interesting, and of particular benefit as background material for our current inquiry into the European Social Fund. The Commission’s recognition of the particular difficulties faced by disadvantaged groups in the labour market chimes with much of the evidence that we have heard in the course of our inquiry, and we would agree with the Commission that investment in vocational training for the 15-24 age group is an important priority. Nevertheless, we were disappointed that your EM did not acknowledge the importance of ensuring that efforts to improve people’s employability are matched by efforts to increase employment opportunities. We are content to release the Draft Report from scrutiny. 25 February 2010

EQUAL OPPORTUNITIES: RIGHTS OF PERSONS WITH DISABILITIES (12892/08)

Letter from Angela Eagle MP, Minister of State, Department for Work and Pensions to the Chairman Thank you for your letter of 26 November enquiring about i) the likely timescale and process for drawing up the Code of Conduct referred to in the above proposal, and ii) when discussions were likely to commence in respect of the Proposal for a Council Decision on accession, by the European Community, to the Optional Protocol to the Convention. Our current understanding is that the Commission is preparing a draft Code of Conduct which it intends to table for discussion with Member States early in the New Year and that it would like to have the Code in place before the Conference of State Parties in September 2010. With regard to the proposal in respect of accession by the European Community to the Optional Protocol, we have no indication yet on the Commission timetable, but we believe that discussions on this matter are unlikely to proceed before agreement on the Code of Conduct is reached. 14 December 2009

EQUAL TREATMENT BETWEEN MEN AND WOMEN ENGAGED IN AN ACTIVITY IN A SELF-EMPLOYED CAPACITY (13981/08)

Letter from Angela Eagle MP, Minister of State, Department for Work and Pensions, to the Chairman Further to my letter of 21 November I am writing to inform the Committee of the timetable of the next phase of negotiations on this Directive and seek clearance of our negotiating position, in advance of the election period and interruption to the scrutiny process. The Directive was formally adopted at EPSCO Council on 8 March and is being transmitted to the European Parliament for Second Reading on 24 March. Discussions in the FEMM Committee are provisionally scheduled for April and the Committee and Plenary votes are scheduled for May. We anticipate that the Directive will go to EPSCO Council 7-8 June for agreement. The timetable is being pushed by the Spanish Presidency who would like to gain agreement on an equality file, and by the new Commission who are seeking progress on this issue. [Type text]

The Council has already agreed to give assisting spouses access to maternity allowance. Our priority in future negotiations with the European Parliament is to maintain the current drafting of Article 7 (access to general social protection), and to resist the widening of preferential access to social security benefits for assisting spouses. We will lobby MEPs and Member States to not go beyond the significant concession already agreed on maternity allowance. Attached is the final Council common position text (not printed), agreed at the March EPSCO, which is entirely as expected. We will share the EP’s forthcoming proposals and keep the Committee informed of progress. 16 March 2010

EQUAL TREATMENT BETWEEN PERSONS IRRESPECTIVE OF RELIGION OR BELIEF, DISABILITY, AGE OR SEXUAL ORIENTATION (11531/08)

Letter from Vera Baird MP, Solicitor General, Government Equalities Office, to the Chairman Thank you for your letter of 20 November. I am sorry that my letter, sent to you on 11 November did not fully answer your queries and I hope that the further information provided below will be helpful in responding to your concerns.

SPECIFIC REGARD TO THE ASSESSMENT OF RISK UNDER ARTICLE 2(7) In my letter sent to you on 27 March, I stated that the French Presidency amendments to Article 2(7) attempted to clarify the text of the Directive. The amendments did this by proposing further factors that might be taken into account when assessing risk. Although the UK Government welcomed these additional factors we stated that we were still concerned that the text might be too restrictive. In your letter dated 23 April and recently, 20 November, you asked what these additional factors were and my apologies to you for not answering this specific query sooner. The additional factors referred to in my letter of 27 March were examples of data or statistics which should not be counted as discrimination in the Directive when using age or disability as a determining factor in the assessment of risk. On 3 November 2009 the Swedish Presidency released a set of drafting suggestions (attached at Annex A) (not printed) concerning the Directive, and as the Swedish Presidency did not restrict this document I am now able to discuss Article 2(7) in further detail. The Swedish Presidency drafting suggestions for Article 2(7) stated: “Notwithstanding paragraph 2, in the provision of financial services, proportionate differences in treatment where, for the service in question, the use of age or disability is a determining factor in the assessment of risk based on relevant actuarial principles, accurate statistical data or medical knowledge shall not be considered discrimination for the purposes of this Directive.” This text remained unchanged from the French drafting suggestions aside from the change of “product” to “service” and the addition of “statistical”. You will note that this has changed from the original draft which read: “Notwithstanding paragraph 2, in the provision of financial services, Member States may permit proportionate differences in treatment where, for the product in question, the use of age or disability is a key factor in the assessment of risk based on relevant and accurate actuarial or statistical data.” The UK Government found both of these sets of drafting suggestions helpful and a step in the right direction, mainly due to the fact that they provided further information on the Commission’s intentions in relation to the proposed Directive.

SWEDISH PRESIDENCY UPDATE During the Swedish Presidency negotiations have focussed on the following areas: [Type text]

— Competence – as discussed below there have been significant amendments to the text that have clarified the balance of competence between Member States and the Community; — The disability provisions, including by aligning them more closely with the UNCRPD and by introducing a clear distinction between the general requirement to improve “accessibility” and the more specific requirement to provide “reasonable accommodation”; — What might constitute legitimate differences of treatment, especially on the grounds of age and disability to make it clear that in some circumstances differences in treatment do not amount to discrimination; — The implementation timetable by providing for separate implementation deadlines for ensuring accessibility in respect of new buildings, facilities and infrastructure, as well as existing buildings, facilities and infrastructure undergoing significant renovation, and for all other existing buildings, facilities and infrastructure. In their progress report to EPSCO the Presidency stated that significant progress had been made, but that there was a clear need for extensive further work on the proposal. We agree with this assessment.

THE SPANISH PRESIDENCY The Spanish Presidency have put this down for political agreement at the June meeting of EPSCO. They are ambitious for the Directive and are keen to reach agreement. However they recognise that there is a considerable challenge in reaching agreement and are keen to engage with supportive Member States, of which we are seen as one.

COMMUNITY COMPETENCE Attached at Annex A (15320/09) (not printed), are the Swedish Presidency’s drafting suggestions. The UK Government believes that they are an improvement on the text and meet some of the concerns that we had in relation to the extent to which the proposed Directive is clear as to the division of competences between the Community and the Member States. These concerns related to the extent of community competence particularly in relation to education and housing. We have always been concerned that there should be no risk of extending community competence through this Directive into areas where it has not previously existed. The improvements are as follows: — New text at Article 3.1 which now makes clear that the Directive only applies in relation to “access to” the areas listed. We think that this new text helpfully clarifies the extent of community competence in the Directive. — New text at Article 3.2 which states that “this directive does not alter the division of competences between the European Community and the Member States.” Whilst an Article 13 Directive could never alter the competence it is reassuring to us to have this confirmed in the text. These two amendments taken with the original text at 3.1 “within the limits of the powers conferred upon the community” set out much more clearly that it is not intended for the Directive to alter the division of competencies between the Community and the Member States.

IMPACT ASSESSMENT AND THE SUMMARY OF CONSULTATION RESPONSES Member States continue to press the Commission during negotiations to outline the potential impact across the EU. They have responded by referring to the original Impact Assessment that they produced. Despite the progress reported above in clarifying the community competence in relation to this Directive the Council have not yet reached agreement, or discussed in any meaningful detail what exactly will be in the scope of the Directive in working group. Until the Council have resolved the question of scope the Government are not able to assess the costs and benefits associated with it. It is our intention to update the Impact Assessment as and when the scope has been determined. [Type text]

As stated in my last letter, we received over 2000 responses to the consultation on the Directive. We have now completed our analysis of these responses and I am attaching a copy of the summary (not printed) that we have produced. We will continue to keep you updated as negotiations on the Directive progress. 21 January 2010

Letter from the Chairman to Vera Baird MP Thank you for your letter of 21 January which was considered by EU Sub-Committee G at its meeting on 28 January. We note that you are supportive of the Swedish Presidency’s amendments in relation to the assessment of risk under Article 2(7). However, we would appreciate clarification as to how the Government would like to see the Article further amended, if at all, in order to address their original concern that the text might be too restrictive. Your account of what was discussed under the Swedish Presidency negotiations is helpful, as is the copy of suggested drafting amendments. We are supportive of the progress that has been made on the proposal to date, though we note that there remain a number of matters to be addressed as negotiations progress. We note that you are somewhat reassured about the impact of the proposal in a number of areas of limited Community competence, most notably education and housing. We would once again like to ask how the potential impact of the proposal across the EU is being assessed. We would also appreciate an assessment of the Government’s outstanding concerns in relation to the division of competence, and an indication of how likely you consider it to be that the Swedish amendments will remain intact in the final text of the proposal. Thank you for sending us a copy of the summary of consultation responses, as promised. We would be interested to know how this information will be used by the Government as negotiations progress. Finally, it would be useful to know how likely you consider it that political agreement will be reached at the EPSCO meeting in June, particularly as the European Parliament must also give its assent to the agreement under Article 19 TFEU. We will continue to hold this item under scrutiny and look forward to hearing from you on the points raised above. 28 January 2010

Letter from Vera Baird MP to the Chairman 1. Thank you for your letter of 28 January. I note that you continue to hold the Directive under scrutiny and hope that the further information provided below will be helpful in responding to your concerns.

FURTHER AMENDMENTS SOUGHT IN ARTICLE 2(7) 2. As you might already be aware, the Government has recently published a policy statement on ending Age Discrimination in services and public functions which it committed to do as part of the Equality Bill. The policy statement was based on a 12 week consultation run by the Government Equalities Office. 3. The further amendments that we seek in Article 2(7) of the Directive are to ensure that the Article is flexible enough to allow us to achieve the policy intentions as set out in the financial services section of the age policy statement. These include some differences in treatment that we think are beneficial and wish to continue. This includes practices such as age limits to products where relevant to risks or costs of that product and the use of age bands that keep costs down for consumers as a whole (so long as they are based on appropriate data about risk). Further detail can be found in the policy statement attached at Annex A [not printed]. 4. The UK is one of several Member States that wishes to ensure Article 2(7) is sufficiently flexible to allow age based differences in treatment to continue in financial services where they have been identified as beneficial. We are currently working closely with other Member States to create text for Article 2(7) which meet these concerns. [Type text]

POTENTIAL IMPACT OF THE PROPOSAL ACROSS THE EU 5. The European Commission released their own Impact Assessment on the Directive which was sent to you on 14 July 2008 as part of the Explanatory Memorandum on this Directive. I have attached it at Annex B [not printed] for your ease of reference. The Government and other Member States felt that this Impact Assessment was rather poor and have continually raised concerns during working group regarding the assessment of the potential impact of this Directive across the EU which have largely gone unanswered. 6. However, during the Government’s 12 week public consultation which ran from May – July 2009 we received many replies from stakeholders who had links with wider European partners across a broad spectrum ranging from trade unions, equality and human rights groups to manufacturers, property developers and businesses. 7. The concerns that the respondees raised informed our ongoing negotiating positions for this Directive and we feel that this has aided our assessment of the impact of the proposal across Europe.

DIVISION OF COMPETENCE AND SWEDISH AMENDMENTS 8. We and some other Member States still have some concerns around the extent to which the text makes clear the extent to which the Directive will apply to Member States’ areas of competence. The Presidency has made efforts to address these concerns in the text, for example through the inclusion of the words “access to” as discussed in our last letter. However the text changes significantly between working groups and on each occasion we have to assess the implications thoroughly. For example in a more recent text the Presidency have removed the words “access to” from Article 3.1 and attempted to deal with the division of competence through amendments to Article 3.2. Our priority is to ensure that the text is clear and unambiguous. 9. Because the text changes so significantly between working groups it is hard to assess whether the Swedish amendments will remain intact in the final text of the proposal. In recent working groups we have seen many Member States submitting their own text suggestions in an attempt to improve the text suggested by the Swedish Presidency.

CONSULTATION 8. We took the evidence submitted from the public consultation into account in reviewing our negotiating objectives for the Directive. The evidence is also being used in working group as we are able to give concrete examples from stakeholders as to where the Directive might or should have an impact.

EPSCO 9. Whilst there are some outstanding issues to be resolved we believe it is possible for these to be resolved before the June EPSCO. However, there are still some Member States who do not accept that the Directive is desirable and we fear it is this, rather than the inability to agree a text that will make agreement at EPSCO difficult. 12 March 2010

Letter from the Chairman to Vera Baird MP Thank you for your letter of 12 March which was considered by EU Sub-Committee G (Social Policy and Consumer Affairs) at its meeting on 25 March. We note, and are grateful for, the further information provided regarding amendments sought to Article 2 (7), the measures the Government have taken to assess the potential impact of the Directive and the use the Government are making of the responses to their consultation. With regard to the impact of the proposal in areas of limited community competence, the Committee notes and welcomes the Government’s efforts to address these concerns and ensure through amendments that the text is clear and unambiguous. However, we note your point that the text alters substantially between working groups and in light of this ask to be kept informed of any significant changes and to see any alternative text. We agree that a clear and unambiguous text is vital. We now clear this document from scrutiny on the basis that there are not any significant changes to the text and would be grateful to be informed of the outcome following the June EPSCO meeting. 25 March 2010 [Type text]

EUROPEAN SOCIAL FUND: VOCATIONAL TRAINING ACTIONS FOR WOMEN (6066/10)

Letter from the Chairman to Angela Eagle MP, Minister of State, Department for Work and Pensions Your Explanatory Memorandum (EM) on the above Special Report dated 22 February 2010 was considered by Sub-Committee G at its meeting of 11 March 2010. We were particularly interested to note the Court of Auditors Special Report as our inquiry reviewing the European Social Fund is drawing to a close. Its recommendation relating to the evaluation of objectives resonates particularly with the evidence that we received. Measuring the effectiveness of the ESF remains a challenge. We look forward to following these issues up in our report and in discussion with the Government and Commission thereafter. We are content to release the Special Report from scrutiny. I do not require a response to this letter. 11 March 2010

FOOD INFORMATION TO CONSUMERS (6172/08)

Letter from Gillian Merron MP, Minister of State, Department of Health, to the Chairman Thank you for your letter of 23 October 2009 regarding the proposal for a Regulation on the Provision of Food Information to Consumers. In your letter, you asked about the proposed rules on the provision of allergen information for non- prepacked foods. The description of non-prepacked foods covers a group of foods sold through a diverse sector of food business including catering outlets, with a high degree of variability in their operation and is, therefore, a complex issue. Nevertheless, the Government, along with all of the Member States represented on the Council Working Group, agrees that it is important that there is a legal requirement to make this information available to people (or their “carers”) with a food allergy, but how this information is made available will depend on the nature of the product and will differ. In other words, subject to progress on the negotiations, there will be a regulatory requirement to provide information on allergenic foods added as ingredients in all non-prepacked foods. The flexibility under discussion is how this information might be provided, e.g. on menus or menu boards or tickets. As to enforcement, it would be an offence under any national implementing legislation for non-disclosure of allergen information in the same way as it is currently an offence for non-disclosure of allergenic ingredients in pre-packed foods. There will also need to be an awareness-raising programme for food businesses, enforcement bodies and consumers around any new requirements. This will be a major improvement to the current situation whereby there is no requirement to provide such information other than under best practice arrangements. As I have mentioned previously, in the UK we have already issued best practice guidance on the provision of allergen information for non pre-packed foods and we are shortly to evaluate its impact and effectiveness. The results of this work will be used to help to inform how we will ensure the best approaches to provision of the mandatory allergen information. On minimum font size, we appreciate the concerns raised by food producers concerning small packages. Other Member States have voiced similar concerns and the Food Standards Agency has commissioned research which should provide the necessary data to make an evidence based assessment of the issue, and assist in identifying possible solutions for exemptions around the minimum font size. Once we have the results we will gladly share them with you. Country of Origin Labelling (COL) has been the subject of some, although not detailed, discussion at the Council Working Group. Of the countries that have spoken, the views are fairly evenly split between those Member States who would like to see COL for primary (presumably agricultural) products and those who would like to see COL remaining voluntary but with stricter criteria, should a claim be made. We do not expect detailed discussion until the Spanish Presidency but the [Type text]

Government’s view is that origin labelling for consumers needs to be improved and we will be active in the debates as to how this will best be achieved. Since I wrote to you in June, the discussions in Council Working Group have continued with a series of meetings under the Swedish Presidency. There has been some useful discussion on nutrition labelling. On other issues, there has also been some progress with the Swedes exploring several options or approaches to try and get Member States to refocus on the key objectives. The meetings have included discussions on defining who within the food chain has responsibility for the accurate labelling of a product and the type of information available for distance selling as well as labelling clarity and date marking. There has been a useful sharing of views on these issues however, further discussion will be required. I will keep you appraised of any significant progress on this dossier. 1 December 2009

Letter from the Chairman to Gillian Merron MP Your letter on the above proposal was considered by EU Sub-Committee G at its meeting of 7 January 2010. We were pleased to note the positive response to our suggestion that the Government give further consideration to the introduction of stronger measures to encourage or require food suppliers to provide allergen information for loose foods as a matter of course. In addition, we support and encourage your suggestion of an awareness-raising programme for food businesses, enforcement bodies and consumers around any new requirements. Regarding the issue of enforcement of any such legal requirement for the allergen labelling of loose foods in the event of alleged non-disclosure of information (which may be hard to substantiate), we would like to request an update from you when further consideration has been given to this issue and how it is best addressed. We would like to accept your offer of sharing with the Committee the findings of the Food Standards Agency’s research into minimum font size requirements and possible exemptions for small packages. With reference to the country of origin labelling of foods, we encourage the Government’s active approach to discussions on this topic and would like to ask for more information about the UK’s ideas as to how origin labelling can be improved for consumers. We would also appreciate an update on this point once further discussion has taken place under the Spanish Presidency. Pending your response and further progress on the points raised above, we will continue to hold the proposal under scrutiny. 7 January 2010

Letter from Gillian Merron MP to the Chairman In your letter of the 7 January 2010 you requested further information on clarity, allergen and origin labelling aspects of the European Commission’s proposal for a Regulation on Food Information for Consumers. Please find below our response to the points you raised in your letter. You were very supportive of the Government’s efforts in raising awareness of the need for allergen information for loose foods. We will keep you informed of future developments as the requirements are clarified and we have opportunity to consider with stakeholders the best approach for managing the enforcement of this issue. We will also share the research findings from the Food Standards Agency’s work on small packages once it has the results, which are currently expected in the next few months. There has been little detailed discussion on Country of Origin Labelling (COL) under the Spanish Presidency but as I have stated the Government’s view is that origin labelling for consumers needs to be improved. You may be interested in research published by the Food Standards Agency at the beginning of the year. The key finding of the research was that although there was interest in origin labelling it wasn’t a key factor in making purchasing decisions. However there was confusion about the meaning of origin labelling particularly with animal products whether it refers to where animals are born, reared, slaughtered or processed. Consumers therefore find origin labelling rules being linked to last substantial change potentially confusing. [Type text]

The research provides the evidence base to support our approach for improved clarity around origin labelling. Since I wrote to you in December, the discussions in Council Working Group have continued with a series of meetings under the Spanish Presidency. There has been some useful discussion on nutrition labelling. On other issues, there has also been some progress with the Spanish exploring several options or approaches to try and get Member States to refocus on the key objectives. The meetings have included discussions on defining who within the food chain has responsibility for the accurate labelling of a product and the type of information available for distance selling as well as labelling clarity and date marking. There has been a useful sharing of views on these issues however, further discussion will be required. I will keep you appraised of any significant progress on this dossier. 23 March 2010

HEALTH: MEDICINAL PRODUCTS FOR HUMAN USE

Letter from Gillian Merron MP, Minister of State, Department of Health, to the Chairman I am writing to update you on the progress of the proposals above, which remain under the scrutiny of the Committee. There have been no developments since I wrote to you in November 2009 as the proposals have not been discussed in Council Working Group or by the European Parliament. I will write to you again when the First Reading has taken place. 22 March 2010

HEALTH AND SAFETY: PREVENTION OF SHARPS INJURIES IN THE HOSPITAL AND HEALTHCARE SECTOR (15305/09)

Letter from the Chairman to Lord McKenzie of Luton, Parliamentary Under Secretary of State, Department for Work and Pensions Your Explanatory Memorandum (EM) on the above proposal was considered by Sub-Committee G at its meeting of 10 December 2009. We regret that your EM provided little detail about what is actually being proposed by the Social Partners in the Framework Agreement. While this information can be found in the Commission documentation, Government Explanatory Memoranda should read as self-contained documents which do not require reference to alternative sources of information. Please could you ensure that future Explanatory Memoranda contain a fuller account of the substantive proposals as a matter of course. On the issue of subsidiarity, you stated in your EM that Commission action was appropriate because the subject matter is within the competence of the Community. While it is the case that the Community has the competence to act in this area, this is not sufficient to guarantee that any action proposed will be consistent with the principle of subsidiarity. We would therefore like to ask for a more detailed analysis of how and why you consider that this proposal is in-keeping with the principle. We would also be grateful if you could ensure that future Explanatory Memoranda separate the two issues of competence and subsidiarity and that a fuller account be given of your considerations with regard to the principle of subsidiarity. This is of particular importance following the entry into force of the Lisbon Treaty on 1 December. With regard to the proposal as a whole, we note that it has the support of NHS employers and trade unions. Nevertheless, we were not entirely clear from your EM what the Government view is in relation to the document and would therefore be grateful if you could confirm whether the Government support the proposal and clarify the reasons underpinning their view. We were pleased to note that you will consult further with small and medium enterprises on the proposed action and would like to ask when this consultation will take place and what the SMEs will be asked about. We would be grateful if you could provide us with a copy of your analysis of the consultation responses in due course, as also with the Government’s Impact Assessment on the proposal. [Type text]

Given the potentially serious nature of sharps injuries, we were particularly concerned by the significant under-reporting cited in your EM. We would be grateful for further information about how this is currently being tackled at an EU-level and how that compares with the action proposed under this Framework Agreement. If there are actions currently underway in the UK, we would also appreciate information on these. Having noted that the proposal gives the option of implementation through national legislation or through Social Partners’ agreement, we would be grateful if you could indicate when your considerations as to the best method will conclude and if you could update us with the Government view in due course. In terms of procedure, we were interested to observe the process that has led to this outcome. It is not clear to us why a proposal from the Commission to the European Parliament and the Council under the ordinary legislative procedure could not have been tabled, allowing for greater involvement of both the EU institutions and national parliaments. Finally, with reference to the European Scrutiny Committee in the House of Commons, we note that concerns have been raised about the use of a Directive as opposed to a Decision to implement the proposal. We will reserve our position on this aspect of the proposal for the time being and would ask for your response to this letter to include an update as to the rationale and justification for the use of a Directive as opposed to a Decision in bringing forward this proposal. Given the number of points that are outstanding at this stage, we will continue to hold this item under scrutiny and look forward to hearing from you shortly on the issues we have raised above. 14 December 2009

Letter from Lord McKenzie to the Chairman Thank you for your letter of 14 December 2009 in response to my Explanatory Memorandum (EM) on the proposed Council Directive implementing the Framework Agreement on the prevention of sharps injuries in the hospital and healthcare sector. I am sorry that you did not find the EM that I submitted as helpful as it might have been. I believe that my Department and the Health and Safety Executive (HSE) have good reputations for the quality of our EMs and this is something we take pride in. I am determined to ensure that we provide you with the highest possible standard of EM. I now turn to the specific issues raised by Sub-Committee G.

SUBSIDIARITY ISSUES On the issue of subsidiarity, the aim of the proposal is to achieve the safest possible working environment for workers in the hospital and health care sector across Europe by preventing injuries to those workers caused by medical sharps at a European level. Action at Community level will help ensure equivalent standards of protection across the European Union (EU) which will benefit the free movement of healthcare workers between Member States. It is important that the high standards in some parts of the sector are replicated across the EU. This cannot be achieved by Member States acting alone. Representatives of employers and employees in the hospital and healthcare sector (HOSPEEM and EPSU, respectively) accepted that EU-level action was needed and negotiated the Framework Agreement. They also jointly requested that their agreement be submitted to the Council for a decision in accordance with Article 139(2) of the then EC Treaty to have a European-wide effect that would be binding on member states.

GOVERNMENT VIEW ON PROPOSALS The Government supports the aims of the Framework Agreement in principle as it contributes to protecting workers (in this case in the health sector) from preventable injuries. However, we are sceptical that more law will, in fact, deliver the required improvements. There are existing EU laws on biological agents and work equipment that, if properly implemented across the EU and followed wholeheartedly by employers and employees alike, would arguably be sufficient to tackle the risks. Nevertheless, the employers and employees are content with the proposal. Moreover, it seems likely that a qualified majority of other Member States will be in favour of the proposal and, on balance, we would prefer to support political agreement to the proposal at Council. [Type text]

STAKEHOLDER CONSULTATION Of course further consultation with stakeholders, including small and medium enterprises will take place during implementation following adoption of the Directive. The content of the Framework Agreement itself cannot be changed, so consultation will focus on the practicalities of its implementation (for example what level of guidance, etc. might be appropriate, how to improve reporting of sharps injuries, etc.). I will provide the Sub-Committee with a summary of the responses to the consultation once it is carried out. Officials are currently undertaking a partial impact assessment of the proposal that will be provided to the Sub-Committee as soon as is possible, followed up by the full impact assessment once the consultation referred to above has been completed. We are not yet able to be firm about the timescale for these consultations, but we anticipate an implementation period of two years after adoption of the Directive.

REPORTING OF INCIDENTS Information on the accuracy of reporting of sharps injuries is hard to come by but anecdotal evidence suggests that there is significant under-reporting. The Reporting of Injuries, Diseases and Dangerous Occurrences Regulations 1995 requires reporting of sharps injuries – but only those where there is a definite risk of infection so a great many “low-risk” incidents are not reported. Under National Health Service reporting schemes employers report approximately 40,000 incidents each year. Again this is considered to be subject to under-reporting – the Royal College of Nursing, for example, estimates that there may be as many as 100,000 such injuries per year. While the specific reporting requirements at local, national and European level in the proposed Directive are still unclear, its implementation could provide an opportunity to improve levels of consistency and reporting of sharps injuries. The Government is not aware of any current EU-level work to tackle under-reporting of sharps injuries but adoption and implementation of the Directive by Member States could contribute toward progress in this area.

IMPLEMENTATION OF THE PROPOSED DIRECTIVE Although the proposal gives the option of implementation through national legislation or through a social partners’ agreement, after further consideration the Government takes the view that the UK lacks the necessary national collective agreement mechanisms to implement successfully through a partnership agreement, particularly as any form of implementation requires there to be effective and dissuasive penalties applicable to infringements of the Framework Agreement. We do not consider that alternative solutions such as NHS management procedures nor oversight by the medical, nursing and other professional regulatory bodies would be appropriate. This is because the Framework Agreement will also apply to the private healthcare sector, outwith the NHS management, and because the duties foreseen in the agreement are intended to be applied to employers (e.g. NHS Trusts, private healthcare companies, etc.) rather than regulated professionals.

PROCEDURE LEADING TO THIS PROPOSAL The Sub-Committee has asked why a proposal from the Commission to the European Parliament and the Council under the ordinary legislative procedure could not have been tabled to allow for greater involvement of both the EU institutions and national parliaments. In fact the idea for a proposal on preventing injuries from sharp instruments originated in a resolution from the European Parliament1 in which it called on the Commission to submit a legislative proposal under Articles 137 and 251 of the then EC Treaty to amend Directive 2000/54/EC on biological agents at work in order to address the need to protect workers from needlestick injuries. Before the Commission can bring forward legislative proposals in the field of employment and social affairs, as an amendment to Directive 2000/54/EC would have been, it is required to consult the social partners on the initiative – the concept of social dialogue was introduced by the Maastricht Treaty in 1993 so is not a new procedure. If the partners decide to initiate bipartite negotiations, i.e. between the relevant organisations representing workers and employers, the Commission has to suspend its own initiative and await the outcome of the negotiations. This is what happened when EPSU and HOSPEEM wrote to the Commission on 17 November 2008 indicating their intention to negotiate an agreement on the prevention of sharps injuries in the hospital and healthcare sector – Article 139 of the then EC Treaty gave the social partners negotiating autonomy and therefore Government had no

1 European Parliament Resolution of 6 July 2006 ( 2006/2015(INI)) [Type text] formal role in the process. Agreements under social dialogue that lead to legislation are rare but not unique, e.g. the revised Framework Agreement on Parental Leave and of course, this initiative. As regards the role of the Council and the European Parliament in social partner agreements – the Council cannot amend their content and can only accept or reject them, while Article 139(2) of the then EC Treaty provided no role for the European Parliament. Article 155(2) of the Treaty on the Functioning of the EU (which re-enacts Article 139 of the EC Treaty) now requires that the European Parliament is informed of social partner agreements.

IMPLEMENTATION BY ‘DIRECTIVE’ RATHER THAN ‘DECISION’ You will be aware that I responded to the concerns of the House of Commons European Scrutiny Committee on the use of a directive rather than a decision to implement the proposal in my recent letter to the Chair, Michael Connarty MP, and which was copied to you. In summary, I support the interpretation of “Council decision” as given by Pat McFadden in his letter to the Committee on 17 November 2009 on the revised Framework Agreement on Parental Leave, i.e. that the term “Council decision” in Article 139(2) of the then EC Treaty had been construed as referring to any type of legally binding instrument provided for under EC Treaty Article 249, including a Directive. I am satisfied that the same situation applies to the Framework Agreement on preventing sharp injuries in the hospital and healthcare sector. I hope this information is to the satisfaction of the Committee. We would like to be in a position to support political agreement to this proposal at the EPSCO Council on 8 March and it would therefore be helpful if the Committee could now clear this proposal from scrutiny. However, if you need more information before doing so, I would be very happy to provide it. 29 January 2010

Letter from the Chairman to Lord McKenzie of Luton Thank you for your letter, dated 29 January, which was considered by EU Sub-Committee G at its meeting of 25 February. We welcome your apology concerning the EM (Explanatory Memorandum) on this proposal and are pleased to note your commitment to providing us with the highest possible standard of EM. Nevertheless, we are concerned that the response to my letter of 14 December has far exceeded the two week deadline and only arrived after being followed up at official level and at a time when you are seeking clearance from scrutiny. We consider this particularly regrettable given the tight timetable envisaged for agreement of the proposal and the short amount of time this has left the Sub- Committee for scrutiny of the dossier. We are grateful for your explanation with regard to the proposal’s compliance with the principle of subsidiarity and agree with the Government’s assessment that no subsidiarity concerns arise with the proposal. You state that the Government wish to support the proposal when it comes before the EPSCO Council for political agreement. While we endorse the aim of the proposal to protect workers and help to achieve the safest possible working environment and hope that it will also help to tackle the significant under-reporting of sharps injuries, we regret that it has not proved possible to achieve this through current legislation, particularly in light of the Better Regulation agenda. That being so, how will you ensure that in implementing this proposal, the aims and objectives are achieved? Do you consider that lessons have been learnt from the incomplete implementation of previous proposals that could have had a similar effect had they been properly implemented? Thank you for your full response to the remainder of our queries, most notably about the process leading to the proposal, the rationale for its introduction in the form of a Directive rather than a Decision, and the Government’s preferred method of implementation. We would also like to accept your offer to send us a copy of the summary of consultation responses and of the Impact Assessments (both partial and complete) when these are ready. Given that the proposal is down for political agreement at the EPSCO Council Meeting on 8-9 March, and following your comprehensive response to our queries, we are content to release the item from scrutiny. 25 February 2010 [Type text]

Letter from Lord McKenzie to the Chairman Thank you for your letter of 25 February, in which you informed me that you were content to release the above proposal from scrutiny. You will wish to be aware that it was subsequently agreed by Member States at the 8 March meeting of the Employment, Social Policy, Health and Consumer Affairs Council. Member States will now have three years in which to transpose the Directive. I do regret that it was not possible to respond to your letter of 14 December within the normal deadline of two weeks. This delay was caused by the need for collective discussions within Government on the issues that Sub-Committee G raised on the proposal’s legal basis. I thought that it was important to ensure that my response was as comprehensive as possible rather than providing a series of more limited replies covering the other issues that you raised, though I accept that this left the Sub-Committee with a shorter time to consider my request for scrutiny clearance. You asked how the Government will ensure that, in implementing the Directive, its aims and objectives will be achieved. I would like to be clear that it was not the intention of my letter of 29 January to suggest that the UK had failed to properly implement previous European legislation that covered the risks concerned. The overall aim of this Directive is reflected in existing domestic legislation, codes of practice and good practice guidelines (see Appendix 1 for examples of the latter [not printed]). However, these are based on the more general and cross-sectoral provisions in, for example, the Framework Directive on measures to improve the safety and health of workers (89/391/EEC) and the Directive on the protection of workers from exposure to biological agents at work (2000/54/EC). This new Directive builds upon those provisions in relation to the hospital and healthcare sector, and provides for explicit duties to be placed on healthcare employers to adopt particular control measures. The signatories of the Framework Agreement included representation from NHS Employers and UNISON and I would expect both to support the implementation of the Directive in the UK. Additionally, the Framework Agreement contains a provision (Clause 11) for the signatories to review its application five years after its adoption date on the request of either party. I hope this information is of help to the Committee. I will provide the other information that you have requested (summary of the consultation responses and the impact assessments) when it is available. 26 March 2010

HIV AND AIDS IN THE EU AND NEIGHBOURING COUNTRIES (15204/09)

Letter from the Chairman to Gillian Merron MP, Minister of State, Department of Health Your EM on the above proposal was considered by Sub-Committee G at its meeting of 10 December 2009. We note that HIV presents a diverse epidemic across the EU and in neighbouring countries, with significant variations in HIV prevalence, transmission routes and treatment services. While we therefore consider that an EU-wide overview and understanding of the epidemic and associated issues has value, we would emphasise that service delivery must remain a matter for Member States, whereby national responses can be tailored to national needs. Such an approach would be in line with the strengthened competence for Member States over health policy contained in the new Article 168(7), TFEU. Further to this, we were disappointed that under the “subsidiarity” section of your EM, you simply state that you are satisfied that the Communication is justified in accordance with the principle of subsidiarity. We would appreciate an outline of the reasons behind this view and urge you to include such an explanation as a matter of course in future Explanatory Memoranda. You suggest that the initiative will help to ensure that the priority given to HIV in the UK is increasingly applied throughout the EU. We are curious as to how this might be delivered, particularly given the aspirational nature of the Communication and Action Plan. Finally, while we note the worthwhile aims of this Communication, we wonder why it was considered necessary to update the last Communication and Action Plan and would appreciate your view as to whether this is symptomatic of over-activity by the Commission. [Type text]

Given the non-legislative nature of this document, we are content to release it from scrutiny and look forward to a response from you shortly on the points raised above. 10 December 2009

Letter from Gillian Merron to the Chairman I am sorry for the delay in replying to your letter of 10 December seeking clarification on three points included in the Explanatory Memorandum (EM) on the European Commission’s Communication on HIV and AIDS. I am afraid that I only became aware of the outstanding enquiries earlier this month, following contact from the Committee Clerk. It appears that we did not receive your earlier letter. I note that the Committee has released the Communication from scrutiny which I welcome. You asked for more detail on subsidiarity. As we mentioned in the EM the Communication recognises that HIV presents a very diverse epidemic across the European Union (EU) and recognises that the principle transmission routes differ depending on geographic location. In the United Kingdom, men who have sex with men remain the group most vulnerable to HIV transmission followed by some migrant groups. In other parts of the EU, transmission is primarily through heterosexual sex or because of injecting drug use. Such variations will require different responses in terms of prevention which the Communication recognises. It also acknowledges that an EU response must take account of regional and local variations in how services are provided. Where the Communication can enhance national and local responses is in the sharing of relevant learning and good practice (for example on targeted prevention) and encouraging improved European-wide surveillance in partnership with the European Centre for Disease Prevention and Control. The Committee also sought clarity on how the Communication will help to ensure that the priority given to HIV in the UK is applied throughout the EU. We see this as a long-term aim but this includes working with the Commission’s AIDS Think Tank to share our best practice and learning including on targeted HIV prevention, working with HIV civil society organisations and people living with HIV in taking forward our policy and programmes. We also believe that our broader legislative and policy changes over the last decade will help to challenge HIV-related stigma and discrimination and we are keen to share our experience with the AIDS Think Tank and others. These changes include the amendment to the Disability Discrimination Act, the Gender Recognition Act and Civil Partnership Act, and the forthcoming Equality Bill. Finally, you wondered why the Commission considered it necessary to update their last Communication covering the period 2006 to 2009 and whether we felt this was symptomatic of over- activity by the Commission. We do not believe this is the case but rather it reflects the need for a sustained and long-term response to HIV. 17 March 2010

INFORMAL HEALTH COUNCIL 2010

Letter from Baroness Thornton, Parliamentary Under Secretary of State, to the Chairman I am writing to provide you with a report of the Spanish Health Informal which was held on 22 and 23 April. The UK was represented at official level. The meeting discussed the A(H1N1) crisis and lessons which might be learned for future epidemics. The meeting heard that a number of reviews were underway. On Health Inequalities the meeting heard presentations from Sir Michael Marmot (University College London) and Dr Margaret Chan (WHO). There was broad support for the intention to agree Council Conclusions on Health Inequalities at the EPSCO Council on 8th June. 29 April 2010 [Type text]

ORGAN DONATION AND TRANSPLANTATION (16521/08, 16545/08)

Letter from the Chairman to Gillian Merron MP, Minister of State, Department of Health Your letter on the above dossiers, dated 25 November, was considered by Sub-Committee G at its meeting of 10 December. We would like to accept your offer of updating us on the outcome of discussions about the legal basis of the proposal once this is known, as also on the latest position following publication of the revised Directive early next year, together with an analysis of whether the UK’s concerns have been met. We note that the Lisbon Treaty came into force on 1 December and that it included important amendments to what was previously Article 152, which is now Article 168. The amendments have clarified the primary role of Member States in both defining and delivering health services. We would be grateful for information from you about whether the revised Treaty has had any bearing on discussions about the legal base and about the text of the Directive more generally. Regarding the points raised by the UK in bilateral discussions with the upcoming Spanish Presidency and with the Commission, we would like to know how the UK’s points were received; and how, if at all, the Government expect to see them addressed. Following the Government’s concerns, accepted by the Sub-Committee, that an upper limit on the temperature at which organs should be transported would be costly and not necessarily cost effective, we would appreciate a prompt update about how this has been addressed following publication of the revised text of the Directive. As most Member States are yet to consider the Sub-Committee’s point about the label of “HANDLE WITH CARE”, we would similarly like to request an update on this in due course. Finally, we note that there was no mention of the Action Plan in your letter. As this still remains under scrutiny, we would like to ask whether there has been any discussion about this. Pending a response to the points raised above, we will continue to hold both items under scrutiny. 10 December 2009

Letter from Gillian Merron MP to the Chairman Following your letter of 10 December, for which I apologise for the delay in replying to you, I am writing to update you on the latest position, address the specific points that your Committee made in your latest letter and seek scrutiny clearance for the draft Organ Directive. Since I last wrote to you on 25 November, negotiations on this Directive have picked up speed considerably as the Organ Directive is a key priority for the Spanish Presidency. We have completed a second read-through of the Directive’s text and the Presidency has recently issued their compromise text which I attach (not printed) for your consideration. The negotiations at official level have gone well and the Government believes that nearly all of the UK’s main concerns have been addressed. In view of this, I am asking your Committee for scrutiny clearance of the Organ Directive to enable UK Health Ministers to agree to this Directive’s adoption at Health Council in June. We believe that this is quite likely as there is considerable momentum from the Presidency, the Council and members of the European Parliament to secure a first reading deal at the European Parliament Plenary session in May in time for adoption at Health Council in June. Your Committee will be aware of the concerns expressed by the Commons European Scrutiny Committee as to whether Article 152 of the EC Treaty, now Article 168 of the Lisbon Treaty, provided a sufficient legal basis for Articles 2, 13 and 15.1 of the draft Organ Directive. In addition, in my letter to you of 25 November, I explained that the UK had raised similar concerns in relation to Article 9. Before I respond to the specific points in your letter to me of 10 December, I thought it would be helpful to outline the progress made in relation to this Directive, including issues surrounding Article 168 of the Lisbon Treaty. As a result of discussions at Health Working Group (HWG), the Presidency has, in its recently issued compromised text, made amendments to Article 13 (principles governing organ donation) and 15.1 (now Article 7.1.a), and has included Recitals 10 and 16 to explain why these provisions are important to ensure the quality and safety of organs. [Type text]

Article 2 sets out the scope of the Organ Directive, but does not have any legal effect on its own. Therefore, although the terms “donation” and “transplantation” still remain in Article 2, it is the provisions in the Articles that have effect which are important. The Government believes that the obligations in the Directive are within the scope of Article 168 of the Lisbon Treaty, as explained below. Article 13 does not affect national provisions on the donation of organs because UK law already ensures that all donations of human organs from deceased or living donors are voluntary and unpaid. Given the Commons Committee’s concerns, which my officials have raised in HWG, the Presidency has made clear in Recital 16 the importance of the provisions in Article 13 to ensure the quality and safety of organs. Recital 16 clarifies that when donation is not voluntary and/or foresees financial gain, the quality of the process of donation cannot be fully guaranteed since improving the quality of life or saving the life of a person is not the main and/or the unique objective to be achieved. The Recital explains that even if the process is developed in accordance with quality standards, the clinical history of the donor may not be accurate since there is an increased risk that the donor or his relatives may withhold vital information if they are seeking financial gain. This in turn would create a safety problem for potential recipients since the medical team would have a limited capability for performing an appropriate risk assessment. Article 15.1 has been omitted and a new Article 7.1.a has been included in the Presidency’s compromise text. Further, to reflect the deletion of Article 15.1, the title of Article 15 has been amended from “protection of the living donor” to “living donation”. The new Article 7.1.a does not focus on the protection of the donor; instead the focus is on the characterisation of all procured organs and donors, whether living or deceased, by the medical team collecting all the necessary information. Article 7.1.a refers to the medical team performing an interview so that the donor can be properly informed of the risks and consequences of donation and transplantation to make them aware of the importance of providing the medical team with all relevant information. This link to quality and safety is explained in Recital 10 and note 6 of the compromise text, which states that “the importance of obtaining an appropriate medical history should be stressed as an essential point for ensuring the quality and safety of organs for transplantation. For that purpose, the concept of properly informing donors/relatives to make them understand the potential risks for the recipient should be included.” The HWG also examined legal competency issues surrounding Article 9 and found that this Article was important to ensure the quality and safety of organs since the requirement to authorise transplantation centres would raise quality and safety standards. Further, regulating transplantation centres was considered important because of the key role they play in checking that the organ characterisation has been completed correctly and that the transplantation conditions have been complied with. The HWG also concluded that transplantation was within the scope of the Organ Directive because the requirements for the collection of follow-up information include unintended and unexpected situations that occur during the transplantation process; the collection of this information is important to monitor and improve the quality and safety of organs. However, to reflect the UK’s concerns about the provisions in this Directive not covering the “medical use of organs”, as required by Article 168(7) of the Lisbon Treaty, the Presidency compromise text (Recital 6.a) clarifies that the surgical act of transplantation is not within the scope of this Directive. In view of the amendments made in the Presidency’s compromise text, the Government believes that Articles 13 and 7.1.a are within the scope of Article 168 of the Lisbon Treaty because the link to quality and safety of organs has been established as explained in Recitals 10 and 16. The Government also welcomes the important clarification of “transplantation” in the Presidency’s compromise text and that provisions in this Directive will not cover the medical use of organs. Turning to other issues, the Government believes that our concerns in relation to this Directive’s regulatory impact have largely been addressed. The Competent Authority will be able to delegate its functions or be assisted by other bodies in carrying out its functions. This will allow a number of existing organisations in the UK to continue carrying out some of the functions referred to in Article 18 with a minimum of regulatory disruption from this Directive. Article 27 has been amended to ensure that this Directive does not prevent Member States from maintaining more stringent protective measures in addition to the minimum standards set out in the Directive’s Annex. In terms of the Government’s concerns that the term “authorisation” could not be read so broadly as to include light touch regulatory schemes, we have obtained movement in the compromise text by [Type text] the inclusion of the term “registration” in the definition of “authorisation” in Article 3. However, inserting the term “registration” is not sufficient on its own and we are seeking further amendments to the text to ensure that hospitals that are already registered under a healthcare regulator are not required to seek a separate registration or authorisation specifically to carry out organ transplantation. The Spanish Presidency is sympathetic to our concerns and we are likely to obtain appropriate wording, either in the Directive’s text or in its recitals, to address this outstanding point. In relation to the Directive’s Annex, the original detailed Annex is likely to be abandoned because there is unlikely to be sufficient time to agree it and that it would be better done by a committee of experts via comitology. The Presidency’s latest proposal is to issue a basic minimum data set of requirements in the Annex with complementary binding requirements being determined under the new Lisbon comitology procedures. We believe that this is a reasonable approach, though we recognise that this new comitology process will need to be handled carefully. In your letter of 10 December, you sought further information on a number of issues: — In view of the Treaty of Lisbon coming into force on 1 December and that it included important amendments to what was previously Article 152, now Article 168 of the Lisbon Treaty, did this have any bearing on discussions about the legal base and about the text of the Directive more generally; — How were the points raised by the UK in its discussions with the Spanish Presidency and the Commission received and were they addressed to the Government’s satisfaction; — How has the issue of the temperature at which organs are maintained in transit been addressed; — An update on discussions relating to the translation of the term “handle with care”; and — An update on discussions on the Action Plan as this is still under scrutiny. I will now deal with each of these points in turn: — The Treaty of Lisbon has not had any material impact in relation to discussions about the legal base. We believe that discussions in relation to whether Articles 2, 9, 13 and 15.1 (now 7.1.a) and their compliance with Article 168 of the Lisbon Treaty would have occurred along similar lines had these discussions related to the previous Article 152. However, the procedures by which acts are delegated to the Commission (the comitology provisions in Articles 290 and 291 of the Lisbon Treaty) have changed and we are negotiating amendments to deal with this change. — The vast majority of the UK’s concerns have been addressed in the Presidency compromise text, as explained above. There are some outstanding concerns in relation to the terms authorisation / registration and the Presidency has more work to do in relation to the technical Annex. However, as explained above, the Government believes that the Presidency is moving in the right direction in relation to the terms authorisation/registration and their proposals for a revised Annex are sensible. — In relation to the issue of the temperature at which organs are maintained in transit, the Presidency compromise text in Article 8 requires that shipping containers are labelled with information, including instructions for keeping the container at an appropriate temperature. This addresses the UK’s previous concerns whilst allowing for future proofing to take account of technological developments and medical advances in the transplantation field. — In relation to your Committee’s concerns that there was not one single commonly understood term or symbol for labelling shipping containers “HANDLE WITH CARE”, a number of options have been discussed in Health Working Group (HWG) including using the wording “Human Organ” or organ specific information such as “Heart” to ensure that the contents and the need to transport it appropriately is understood in all [Type text]

languages. Although this has still to be finalised, the concerns of the scrutiny committee are understood. — In relation to the Action Plan, although separate to the Organ Directive, we are suggesting that scrutiny is maintained. We are in the first year of a six year implementation programme. The UK plays a key role in developing priority actions and I intend to report back to your Committee on the Action Plan following the next plenary meeting of Member States in June. The draft Organ Directive is currently being considered by MEPs and a vote on the Organ Directive will be held at the European Parliament’s plenary session on 18 May. In the meantime, negotiations among Member States and between the Presidency, the Council and members of the European Parliament will continue. Should a first reading deal be reached (which is likely in view of the commitment on all sides to achieve this), the Council will seek to adopt this Directive at Health Council on 7 and 8 June. In view of the progress made in negotiations and the timetable described above, I am seeking your Committee’s clearance for the Organ Directive. 18 March 2010

Letter from the Chairman to Gillian Merron MP Your letter of 18 March 2010 on the above Proposal and Action Plan was considered by Sub- Committee G (Social Policy and Consumer Affairs) at its meeting of 25 March 2010. We found your letter helpful. It provided useful clarification on the work undertaken to ensure that the Directive is in line with the Treaty. Useful progress has clearly been made on this important dossier of particular interest to the Committee in the light of our report on the subject. In our report, we emphasised that the Directive should not be overly bureaucratic and we therefore welcome the information from the Government as regards the regulatory impact of the Directive. We were encouraged to learn that the Sub-Committee’s concern about the label of “HANDLE WITH CARE” is under discussion. Clarity on this is clearly required, and we look forward to learning how it is resolved. Given your expectation that a First Reading deal with the European Parliament will be reached in the coming weeks and that the Directive will be on the agenda for adoption at the June Health Council meeting, we are content to release the draft Directive from scrutiny. As you suggest, it would be appropriate to retain the Action Plan under scrutiny pending further developments. We look forward to information from you on the outcome of the Council’s discussions. 25 March 2010

PARENTAL LEAVE (12761/09)

Letter from Pat McFadden MP to the Chairman Thank you for your letter of 20 November informing me that the Committee has released this proposal from scrutiny. I am pleased to inform you that the proposal was agreed in Council on 30 November. The UK now has two years to implement the changes set out in the proposal once it is adopted. The Government will consult in due course on how best to transpose the revised Directive. In the course of this consultation officials will discuss the possible impact of the changes with small business representatives as well as wider business, employee and family group representatives. You requested some further information about how we would ensure that small firms were not adversely affected by the implementation of the revised Parental Leave Directive. The consultation will take into account the needs of small businesses. In addition, the Directive allows us to make special arrangements to meet the operational and organisational requirements of small undertakings. 8 December 2009 [Type text]

PHARMACOVIGILANCE: PHARMACOVIGILANCE OF MEDICINAL PRODUCTS (17501/08, 17502/08)

Letter from the Chairman to Gillian Merron MP, Minister of State, Department of Health Your letter of 18 March 2010 on the above proposals was considered by Sub-Committee G (Social Policy and Consumer Affairs) at its meeting of 25 March 2010. We are grateful for the information that you have provided on the outcome of the public consultation and on developments in the Council and European Parliament. It seems to us that good progress has been made and in a welcome direction and we are therefore content to release the proposals from scrutiny in advance of any vote at the June Council. We look forward to information from you on the outcome of the negotiations. 25 March 2010

Letter from Gillian Merron MP to the Chairman I am writing further to my brief update in November 2009, to update you on progress in negotiations on these proposals, to provide you with the outcome of our public consultation last year and to ask you if the Committee would consider clearing scrutiny on these proposals in view of the possibility that Member States may be asked to vote on them at June’s Council meeting. I last formally updated you on progress on these negotiations in November 2009, and although my officials have been in contact with the Committee Clerks since then, negotiations continued under the Swedish Presidency to the end of 2009, and there were not any significant developments to report. Negotiations are now being taken forward by the Spanish Presidency, who have scheduled an ambitious programme of working group meetings and are beginning to make real progress in finding consensus on the wording of key provisions in the Commission’s proposals. In particular we expect the Council to adopt wording that is acceptable to the UK on the structure of the new Pharmacovigilance Risk Assessment Committee (PRAC), on representation from each Member State and the need for explanations to be given if other committees are minded not to accept their expert advice. We also expect there to be clear provisions that require an independent audit of the functionality of the EU database (Eudravigilance) and its ability to send relevant adverse reaction reports immediately to the appropriate Member State before we accept that companies may submit information about adverse reactions to their medicines direct to the EU database. Other important proposals which the UK supports such as streamlining procedures and reducing duplication of effort between Member States have been retained, with widespread support amongst the Member States, as have proposals for risk management plans to be developed for each new medicine coming to the market. We have also seen the draft report from the European Parliament (EP), and although the EP vote will not be until later in the spring, we are encouraged to see that the report adopts a position that is very similar to that of the UK on the key provisions. In particular it supports the view that the PRAC should include representation from each Member State. The public consultation on these proposals took place between 8 June and 31 August 2009. MHRA received 19 responses to the consultation, and the vast majority of these offered support for our proposed negotiating position. A summary of responses is attached at Annex A for your information [not printed]. You will note a reference to intensive monitoring markings in the summary of responses (paragraphs 10-13) – although the UK maintains support for this provision, and it is also supported by the EP draft report, the majority of Member States have not warmed to the proposal, and it may not, therefore, survive in the final text. In summary, the Government’s position on these proposals is shared by a majority of Member States, and the Council working group is beginning to coalesce around the proposals as they are currently drafted. Although it remains unclear at present whether the Spanish Presidency can achieve sufficient agreement amongst all the Member States to allow them to include these proposals on the agenda for June’s Health Council for agreement, if they do manage to do so it would be most uncomfortable for the UK, as a strong supporter of these proposals, if we were not to be in a position to vote on the issue. We will continue to negotiate on all of the above areas to reach an acceptable outcome for the UK. [Type text]

18 March 2010

PHARMACOVIGILANCE: FALSIFIED MEDICINAL PRODUCTS (17504/08)

Letter from the Chairman to Gillian Merron MP, Minister of State, Department of Health Your letter of 18 March 2010 on the above proposal was considered by Sub-Committee G (Social Policy and Consumer Affairs) at its meeting of 25 March 2010. We found your report on developments in Council useful and we consider the approach adopted satisfactory. The one area of considerable uncertainty would appear to be identification of those medicines to which the proposed safety feature would apply. We note and understand why it may be considered that there is little risk of low value generic non-prescription medicines being counterfeited, but we would nevertheless wish that these be closely monitored for any cases of fraud if they are excluded from the safety feature requirement. Furthermore, we would remind you of our original concern about the lack of detail concerning the available technology for introduction of such a safety feature. Given the desirability and importance of this legislation, we are content to release the proposal from scrutiny, but we would emphasise particularly the need for clarity on the medicines to which the safety feature should be applied, and the need for urgent work on identifying appropriate and cost- effective safety features that might be used. We look forward to hearing the outcome of discussions in Council. 25 March 2010

Letter from Gillian Merron MP to the Chairman I am writing further to my brief update in November 2009, to update you on progress in negotiations on these proposals and to ask you if the Committee would consider clearing scrutiny on these proposals in view of the possibility that Member States may be asked to vote on them at June’s Council meeting. I first notified you of the Commission’s proposed anti-counterfeiting measures in January 2009, setting out the key elements of the proposals and the proposed UK negotiating position on them. I last formally updated you on progress on these negotiations in November 2009, and although my officials have been in contact with the Committee Clerks since then, negotiations continued under the Swedish Presidency to the end of 2009, and there were not any significant developments to report. Negotiations are now being taken forward by the Spanish Presidency, who have scheduled an ambitious programme of working group meetings and are beginning to make real progress in finding consensus on the wording of key provisions in the Commission’s proposals. The current position on the key elements in these proposals is as follows:

WHOLESALE DISTRIBUTION The Commission wants to ensure that all parties involved in the distribution of medicines comply with the wholesale distribution requirements set out in Directive 2001/83/EC. This includes requirements to verify compliance with good distribution practice of the distributor supplying the product and to verify the manufacturer if importer holds a manufacturing authorisation. Under current arrangements, not all parties are required to comply with EU requirements. If, however, a medicine is to be exported to a 3rd country (outside the EU) there is no requirement for such products to have a licence or for an exporter to purchase or supply only holders of a distribution authorisation with the medicine. These provisions are supported by the Government, and have been broadly agreed during Council negotiations. The European Parliament’s draft report also supports these measures.

SAFETY FEATURES Safety features include measures to identify individual packs, a tamperproof seal and covert or forensic measures. The Commission proposals had restricted this provision to prescription medicines, [Type text] with a risk assessment to be undertaken that would allow certain prescription medicines to be excluded from the requirement. Whilst we do not want safety features to be affixed to all licensed medicines (this would be disproportionate and not in line with Better Regulation principles), we do want the option in the legislation to extend the requirement for safety features beyond prescription-only medicines when there is a risk of them being counterfeited. The agreed UK position has therefore been to seek to ensure that the scope of this provision will allow safety features to be affixed to certain non- prescription drugs on a risk basis. For example, the weight-loss drug Alli (Orlistat) is supplied without prescription in the UK, and has now been counterfeited in the United States. Alli has been targeted by counterfeiters because it sells in high volumes and at a high price. Support is growing amongst the Member States for an overall risk based approach to the application of safety features which, because it will include the cost of medicines as one element of the criteria for assessing risk, will ensure that most prescription medicines will be protected by the proposed safety features. Those likely to be excluded are lower-priced generic copies, which we have also argued should be exempted. We are therefore confident that the agreed position on this provision will meet UK requirements. The detail of the technology to be adopted for the safety features to apply in the EU will be set out in later EU legislation.

WHOLESALE DEALERS & GOOD DISTRIBUTION PRACTICE The Commission wants to ensure that wholesale dealers purchasing medicines from other wholesale dealers are required to verify that the supplying dealer is compliant with EU good distribution practices. Where the product is obtained from a manufacturer or importer, the wholesale dealer must verify that they hold an extant manufacturing authorisation. This will ensure reliability of business partners and compliance with good distribution practices throughout the supply chain. These provisions are supported by the Government, and have been broadly accepted in Council negotiations. The European Parliament’s draft report also supports these measures.

ACTIVE PHARMACEUTICAL INGREDIENT & EXCIPIENTS The Commission’s proposals aim to strengthen requirements for imports of Active Pharmaceutical Ingredients (APIs) from countries outside the EU if it cannot be established that the regulatory framework in the respective 3rd country ensures a sufficient level of protection of human health for products exported to the EU (for example by regular audits of manufacturers of APIs). APIs are starting materials for medicines and are often manufactured outside the EU – in places such as China and India – and there is currently no formal mechanism for ensuring that they are manufactured in accordance with EU good manufacturing standards. These provisions are supported by the Government, and have been broadly accepted in Council negotiations. The Parliament rapporteur’s draft report also supports these measures. During negotiations proposals have also been brought forward for the introduction of a level of control over certain categories of excipients (products with no pharmaceutical effects that are added to medicines; for example to stabilise the formulation). There have been significant occurrences where poor quality or contaminated excipients have posed a risk to public health, and we agree that all components of a medicine should be subject to an appropriate level of regulation. We have agreed that this represents an important addition to the Commission’s proposals and the inclusion of excipients in the anti counterfeiting proposals is also supported in the European Parliament’s draft report.

INSPECTIONS The proposals strengthen rules for inspections, including increased transparency of inspection results through publication in the EU database managed by the European Medicines Agency (EMEA). This will ensure that cases of non-compliance as well as compliance with EU standards of good manufacturing compliance and good distribution practice are entered into the EU database. The Commission will also list the 3rd countries (i.e. outside the EU) that have implemented EU-level standards of good manufacturing practice. These provisions are supported by the Government. However, there is continued uncertainty about how the Commission should confirm compliance by 3rd countries with appropriate standards of manufacturing practice. We believe that this must include more than a “paper exercise” and will be pressing for wording that will achieve our aim. There is growing support among other Member States [Type text] for this view. The European Parliament’s draft report supports the measures as drafted by the Commission.

MEDICINES IN CUSTOMS FREE ZONES The Commission has made proposals to develop detailed requirements to clarify the rules applying to medicines held in customs-free zones. There is currently legal uncertainty about the powers of entry and inspection in customs zones. Whilst final provisions and the detail are to be set out in separate texts, the Commission’s proposals will confer the power to the Commission to do this and these will now need to reflect changes in procedures introduced in the Lisbon Treaty, and on which the Council is currently working. There is strong support for greater clarity about powers that regulators have to operate within customs-free zones. In summary, the Government is confident that it will reach its key negotiating objectives on measures to strengthen the supply chain. Member State opinions in the Council working group are beginning to coalesce around the proposed amended texts. Although it remains unclear at present whether the Spanish Presidency can achieve sufficient agreement amongst all the Member States to allow them to include these proposals on the agenda for June’s Health Council for agreement, if they do manage to do so it would be most uncomfortable for the UK, as a strong supporter of these proposals, if we were not to be in a position to vote on the issue. 18 March 2010

SEASONAL INFLUENZA VACCINATION (11970/09)

Letter from Gillian Merron MP, Minister of State, Department of Health to the Chairman My colleague Ann Keen, the Parliamentary Under-Secretary of State, sent you an Explanatory Memorandum (EM) on this Recommendation on 30 July. Your Committee considered the EM on 15 October and indicated that it wished to be kept informed on negotiations. I am now in a position to do so. Discussions on the draft involving the Commission, the Presidency and Member States have taken place in October and November. The UK's drafting amendments to meet its negotiating objectives have all been accepted. A copy of the latest version of the Recommendation is attached as an Annex. In summary, the main changes that have been made to the draft are: — all references implying obligations on Member States to take particular actions have been deleted; — the words "Member States should" have been replaced by "Member States are encouraged to" throughout; — the text now reflects the fact that in some countries health services are organised on devolved principles; — the list of "at risk groups" has been deleted, leaving Members States free to determine these; — the reference to target vaccination uptake rates have been watered down both in terms of deadlines and the groups covered, so that it is totally clear that vaccination rate targets are now aspirational and non-binding on Member States; and — the reporting arrangements have been minimised. During the course of discussions on the Recommendation, it was made clear by both the Commission and the Presidency that the purpose of the Recommendation was to bring other Member States up to the same level on flu immunisation as counties such as the UK and Netherlands which currently have the highest uptake rates. As noted in the July submission, the UK is already taking the steps encouraged by the Recommendation. The UK has secured significant changes to the original draft and has achieved all of its negotiating objectives. The status of the Recommendation as non-binding on Member States is now clear and I am confident that its ratification will not impose any additional onerous requirements on the UK. [Type text]

A further meeting of the EU Working Party on Public Health is due to take place in early December to seek to agree a final version of the Recommendation. The Swedish Presidency is keen to get this Recommendation adopted before the end of December, assuming that a reasonable consensus can be reached at the next EU Working Party on Public Health. If so, the Swedes may seek to get this Recommendation adopted as an "A Point" at a non health Council meeting in December. I look forward to receiving the views of the Committee on this matter. 2 December 2009

Letter from the Chairman to Gillian Merron MP Your letter of 2 December 2009 on the above Recommendation was considered by Sub-Committee G at its meeting of 10 December. We welcome the changes that have been negotiated to the text of the Recommendation. It seems to us that the text is now consistent with the principle of subsidiarity and we are content to release it from scrutiny. 10 December 2009

SOLIDARITY IN HEALTH: REDUCING HEALTH INEQUALITIES IN THE EU (14848/09)

Letter from the Chairman to Gillian Merron MP, Minister of State, Department of Health Your Explanatory Memorandum (EM) on the above Communication was considered by Sub- Committee G at its meeting of 10 December 2009. We consider that there are sufficient grounds to support an EU policy response to this important issue, and we are therefore content that the Communication is consistent with the principle of subsidiarity. While the policy initiatives proposed by the Commission may be largely acceptable, we consider that the devil will lie in the detail of what is proposed. We would draw your attention to the suggestion that Member States be encouraged to make better use of existing options under the Common Agricultural Policy (school milk scheme, school fruit scheme, food for deprived persons) to improve the public health of vulnerable groups and rural areas with high needs. The Government (Defra) have previously expressed doubt as to whether this is an acceptable use of EU rural development funds, and our Environment and Agriculture Sub-Committee has shared that scepticism. We would therefore appreciate clarity on your own position in that regard, and whether you intend to raise the matter with the Commission. The Communication is a non-legislative, strategic document. We are content to release it from scrutiny and look forward to your comment on the outstanding issue raised above. 10 December 2009

Letter from Gillian Merron MP to the Chairman Thank you very much for your letter of 10 December about this communication and I am grateful that you are content to release it from scrutiny. I am sorry about the delay in replying to the points in your letter. This was the result of confusion over the delivery of the original letter. The communication is consistent with subsidiarity - as you say - leaving the initiative about how to address this communication to Member States (MSs). It offers examples and suggestions about how MSs might take further action in this area. It identifies current EU flanking policies that draw on the wider, social determinants of health that - as the recently published Marmot review makes clear - are key to reducing health inequalities. I support this broad approach. The suggestions in the communication cover a range of activity but it is a matter for individual MSs to decide how to respond to these various suggestions. This applies equally to what it says about the use of CAP initiatives to improve health. It encourages MSs to use existing options such as the school fruit scheme, food for deprived persons programme and the school milk scheme as a way of supporting vulnerable groups and rural areas with high needs. [Type text]

While we support a number of schemes to improve the nutrition of such groups and areas, The Government does not look to the EU for funding such programmes. In terms of the detail in the communication, the school fruit and vegetable scheme for England predates the EU scheme, is separate from it and receives no EU funding. We do not participate in the food for deprived person's programme but we do have our own statutory Healthy Start scheme that targets vulnerable and disadvantaged mothers and babies on benefits and provides milk and essential food items. On the school milk scheme, it is local authorities (rather than the Government who decide on whether to make milk available in schools. Where milk is provided, it is at the expense of individual parents unless the child is eligible for free school meals in which the local authority will pay for the milk for those children. Local authorities claim a contribution to the costs of milk from the EU subsidy scheme so that the amount paid from local authority funds or by parents is net of this contribution. The Government has not sought the use of EU rural development funds to support national public health initiatives, but we remain of the view that it is for individual MSs to make their own decisions about how they respond to the advice in the communication about the use of these funds. In light of this view, I will not be raising the issue with the Commission. I hope this reply is helpful. 16 March 2010

SPORTS POLICY

Letter from Gerry Sutcliffe MP, Minister for Sport, Department for Culture, Media and Sport, to the Chairman Following my letter of 28 January 2009, I am writing to update you on the progression of the UK’s EU sports policy, with particular regard to the European Commission’s White Paper on Sport and associated discussions. Since I last wrote to you, there have been two further meetings of the EU Sports Stakeholders Working Group, which includes representatives from the FA, Premier League, LTA, RFU, RFL, ECB, CCPR and Sport England (the latter two representing many of the smaller sports). UK Sport has since been invited to join this Working Group and will be attending the next meeting which is scheduled for March this year. There have also been two further meetings of the Devolved Administration EU Sports Working Group with the next meeting also scheduled for next month. As I’ve previously stated, discussions with domestic sports plays an important role in concluding our policy position on many issues.

EU PRESIDENCIES During the last two EU Presidencies in 2009, held by the Czech Republic and Sweden, there were no informal meetings of EU Sports Ministers, however, there were Presidency conclusions resulting from informal meetings of EU Sports Directors which the UK was represented at. The key conclusions of the Czech and Swedish Presidencies included references to ensuring: — That sport policy should be aimed at supporting and providing the sport sector with the best possible conditions for its activities. — That if the sport sector takes responsibility, it will have a greater chance of gaining acceptance for its regulatory framework within the framework of Community law. — That the Commission would not support any general exemptions from the Lisbon Treaty’s provisions regarding the sport sector, but was committed to continue the dialogue with the sport sector and Member States to further clarify the legal conditions, area by area. — That the sport sector has special responsibility for ensuring that any regulation was effective, proportional and necessary. [Type text]

— That the fight against doping in sport must include efforts to protect individuals’ fundamental rights in Europe, including in the area of data protection and the right of sportsmen and sportswomen to compete in clean sport on equal terms with other athletes. — For the Commission to organise a conference on internal market barriers to the funding of grassroots sport, to complement the study currently underway. To include participants from across the sports and gambling movements. — That a study on the access of non-nationals to individual sport competitions was being launched. — Recognition of the importance of the non-profit sports movement and volunteering in sport based on a Czech survey in advance of the European Year of Volunteering in 2011.

LISBON TREATY – IMPLEMENTATION You will already know that, with the Lisbon Treaty being ratified in December 2009, sport now becomes a formal EU competence for the first time, similar in scope to the existing competences for education, culture and youth. Some of the consequences are still to be determined. However we already know that the the newly-appointed Commissioner for Education, Culture, Multilinguism and Youth (including sport) is Mrs Androulla Vassiliou from Cyprus. The Commission’s Sport Unit will issue a formal Communication later this year on the implementation of the Lisbon Treaty regarding sport. An EU ‘mini’sport programme, due to run in 2012-2013, will be drafted in parallel and this will feed into the 2014-2020 EU sport programme which will be drafted next year. There will also be a new formal Council structure for sport. This will involve meetings of EU Sport Ministers within the Education Council, and a new Council Working Party for Sport. The first formal Sport Council Meeting will take place on 11 May in Brussels. This will follow the informal meeting of EU Sports Ministers which will take place on 20-21 April in Madrid. We expect that both the Communication and the ‘mini’ sport programme will be brought before the new Council in the autumn. Together with special events in the field of sport proposed and approved by the European Parliament, the total EU budget for sport in 2010 will be €11 million. Specifically, there will be a new call for new projects and proposals this year, with a total budget of €3 million.

BILATERAL MEETINGS I recently held a helpful bilateral meeting with my Spanish counterpart, Mr Jaime Lissavetzky, to find out more about Spain’s sporting priorities for its current EU Presidency and to present the UK’s views. I have now held a similar meeting with my Belgian counterpart, Mr Philippe Muyters, to discuss their priorities for the EU Presidency in the second half of this year. One of the priority areas that Spain has indicated it would like to progress during its Presidency is the idea of a permanent EU sports Structured Dialogue mechanism with the International Olympic Committee and other international sports federations. I agree with the principle of this proposal and I am keen to ensure that the full breadth of the sport movement is included, particularly so that national sport voices can be clearly heard. I believe that to do otherwise is likely to result in a one- sided discussion with the risk of conclusions that do not fit with the reality of the sporting landscape, particularly here in the UK. I am pleased to have gained support for this view from a number of other countries and we will ensure that we continue to work closely with sports stakeholders to get the best possible outcome on this issue. I have taken the opportunity of meetings with my Spanish and Belgian counterparts to welcome the Commission’s intention to focus attention on the issues of the new digital economy, intellectual property rights and related broadcasting issues. It is vital that sports’ voice continues to be heard loudly and clearly in these discussions. The UK will continue to advocate strongly on these areas as the Commission’s policy proposals are developed in the light of the new Lisbon Treaty. [Type text]

COMMISSION WORKSTREAMS A new Working Group on Education and Training in Sport was formed last year to focus on the promotion of dual careers for athletes. The UK successfully hosted a meeting of the Group in London in December 2009, including a visit to Chelsea’s Academy. The UK continues to be represented on the other Working Groups: the White Paper on Sport; Sport and Economics; Sport and Health; and Non-Profit Sport Organisations. One outcome of the UK’s membership of the Working Group on Sport and Economics was the publication of EU- comparable data on the importance of sport to the economy in the UK. The key findings show the value of consumer expenditure on sport being over £23bn per year, with sport related employment accounting for 569,000 jobs. Work will continue by publishing the UK’s results for each year from 2005 to 2009 by the end of 2011. Spain has indicated that it would like to form a new Working Group on Social Exclusion, Poverty and Equal Opportunities. The UK does not object to this in principle, but has also called for the period of adjustment after the Lisbon Treaty adoption to result in the minimum possible number of working groups, with the focus firmly on practical action. The Commission hosted a large-scale conference in autumn 2009 on the topical issue of professional sport, governance and financial licensing. The context for the conference was football, but other sports were also included. The Commission indicated their satisfaction with the widespread support for the principles presented by UEFA on what they have termed “financial fair play”. It is clear that the Commission will look to other sports to take a similar approach to governance issues. Our approach has been to welcome the work carried out by the international football authorities in this area, whilst remaining conscious of national competence and defending the principles of subsidiarity. In a related area, the Commission has recently published the conclusions of its report on players’ agents. The report is equivocal on the need for EU-wide regulation. The next stage is for the Commission to produce a formal impact assessment on the recommendations. The UK will remain engaged on this issue, but it does not appear as though this is an area where there will be immediate action.

CONCLUSION With the ratification of the Lisbon Treaty there is no doubt that we are entering a new period of challenges and opportunities for the UK in the area of sport. But based on the progress made over the last year, we can be confident that by continuing to work closely with our sports stakeholders we can ensure that we get the best possible deal for the UK and for our sports. The UK will continue to defend the principles of subsidiarity; to ensure that national voices on sport are heard clearly in Brussels; and that action taken at EU level is clearly adding value, rather than duplicating national competences. I believe that through our active, challenging and proportionate engagement we can continue to both shape the agenda and benefit from EU-wide action on sport. I propose to write and provide you with a further update on the Government’s EU sports policy discussions towards the end of this year. 10 March 2010

WORKING TIME: ROAD TRANSPORT WORKING TIME

Letter from Paul Clark MP, Parliamentary Under-Secretary, Department for Transport, to the Chairman I am writing to update you and the members of your Committee concerning the progress of the above proposed amending Directive. I am afraid that, as you will see, negotiations have not yet reached a point where we can give your Committee a clear picture of the outcome. Following my predecessor’s letter of 11 March 2009, the Transport Council agreed a ‘Common Approach’ on the proposal, which included an amendment that would allow Member States to have the flexibility to choose, when transposing any changes, whether to bring the self-employed in-scope of the Directive in their own territory. The UK was in support of this amendment. Progress in the European Parliament was not straightforward. Following the rejection of the Commission’s proposal by the lead European Parliamentary Committee (the Employment & Social [Type text]

Affairs Committee (EMPL)) on 2 March 2009, the European Parliament rejected the Commission’s proposal at First Reading during its Plenary session in Strasbourg (in a narrow vote: 332 in favour of rejection and 302 against rejection). The proposal was not withdrawn by the Commission and it was referred back to the EMPL Committee. On 29 September 2009, following the European elections the new EMPL Committee rejected (by one vote) a report that intended to subject self-employed drivers to the same rules as employed drivers. This allowed a new report to be written and a new Rapporteur, Edit Bauer, was appointed. A new Rapporteur, Saïd El Khadraoui, was also appointed in the TRAN Committee who were scheduled to submit an opinion to the EMPL Committee. The TRAN Rapporteur’s draft opinion was released on 5 January 2010 and was considered on 26 January 2010. In the vote on 23 February 2010 the draft opinion was narrowly rejected. The TRAN Committee will not therefore provide an opinion to the EMPL Committee. The draft EMPL Rapporteur’s report is currently under consideration by the EMPL Committee. With the exception of a reference to the consideration of extending the scope of the Directive to vehicles of less than 3.5 tonnes, the UK can fully support the Rapporteur’s draft report. Amendments to this draft report, proposed by EMPL Committee members, are currently being reviewed by the UK Government. These include a number of amendments which the UK Government cannot support, as they would result in the inclusion of the genuine self-employed, the extension of the scope of the Directive to vehicles of less than 3.5 tonnes, and a redefinition of the “night work” period which would make the legislation more restrictive. Further brief discussions took place at EMPL Committee on 17 March 2010, during which MEPs acknowledged that it would be difficult to achieve a compromise between the opposing views over inclusion or exclusion of the self-employed. The Committee’s vote on the report will take place on 28 April, with a subsequent vote expected in Plenary in June 2010. Any political agreement will therefore be in June 2010 at the very earliest (the Transport Council is on 24 June 2010). I will keep your Committee informed of the outcome of these discussions. 22 March 2010

YOUNG PEOPLE: PROMOTING LEARNING AND MOBILITY (11968/09)

Letter from David Lammy MP, Minister for Higher Education and Intellectual Property, Department for Business, Innovation and Skills, to the Chairman Thank you for your letter of 15 October regarding the above Green Paper consultation on learning mobility. I attach a copy of the Government’s response to the paper. This outlines our views and examples of good practice in supporting mobility. It also states our opposition to any targets in this area. You asked about the discussion and Conclusions on mobility agreed at the Education Council in November 2008. The discussion focussed on the extension of mobility beyond students, to benefit other young people. Jim Knight represented the UK at this meeting and explained that widening mobility is one of our main objectives. Reaching out to underrepresented groups and regions of the UK is thus a key target of the organisations responsible for delivering mobility programmes. We argued that a period of mobility is a valuable opportunity for young people and that we should work to make this available to as many people as possible. This view is in contrast to that of some countries who want to greatly extend mobility opportunities solely for students. We do not believe that this is the best use of resources and we worked hard to ensure that the Conclusions reflected our view and did not support making mobility compulsory during any period of study.

“QUALITY MOBILITY”: You asked about a definition of quality mobility. We would define quality mobility experiences to mean experiences that are linked to specific learning outcomes and lead to the attainment of qualifications or professional experience. Periods abroad should also meet the principles outlined in Recommendation 2006/961 of the European Parliament and the Council on mobility within the Community for education and training purposes. Both of these criteria are in line with the Commission’s view outlined in the Green Paper. [Type text]

FINANCIAL IMPLICATIONS: We do not anticipate any great increase in mobility in the short term that will lead to increased costs. We will not support any increase in funding for the current education and youth programmes which run to 2013. Furthermore, we will only accept increased funding beyond this date that comes from within the existing EU budget. It is worth noting that the UK benefits from the funding arrangements for the EU programmes. For an annual UK contribution of £4M the Commission provides £60M to support UK projects. For this reason, it would be beneficial for the UK if other types of education projects were linked to EU funding. For example, the school and higher education projects we undertake with third countries outside the EU. We will await with interest proposals from the Commission following this consultation. 16 December 2009