83 boulevard Voltaire - (F)75558 PARIS CEDEX 11 - Tél. : 33 1 49 23 72 80 / Fax : 33 1 48 07 87 32 N°1004 LA REVUE Translated from Rev Prescrire July-August 2004; 24 (252): 481. Medicines in Europe: the most important changes in the new legislation As we digest the results of the European elec- But we must not drop our guard: patients, tions and the last-minute agreement on the health professionals,consumers,health insurers European Constitution, the drafting process of and concerned politicians still have to ensure that the new legislative framework on medicines for the “competent authorities” fulfil their new human use reminds us once again that European obligations and make the pharmaceutical citizens’ voices can and must be heard. industry respect the legal framework that For more than two years the pharmaceutical European society has chosen for it. majors and their lobbyists took it for granted that “Europe” is not some distant land,but is at the they could obtain made-to-measure legislation heart of many of the most important decisions supporting their own narrow financial that shape our society.And Europe is neither ÉDITORIAL Action bears fruit interests, with scant regard for public health inaccessible nor incomprehensible:we just have or for the economic survival of national health to roll up our sleeves and make sure that care systems. special interest groups are not given a free hand. What they failed to realise was that Euro- Finally, Europe is not “too technical”: each new pean citizens from all quarters, including this dossier implies important choices for society. Journal, its subscribers, the “Association Mieux Europe was founded on the notions of free Prescrire” and the diverse member organisa- trade and free circulation,and was bolstered by tions of the Medicines in Europe Forum would the successful introduction of a single currency. come together to scrutinise the draft texts, In future,“Europe” will be increasingly synony- explain the stakes, sound the alarm, make mous with welfare and public services, chief counter-proposals, meet with European among which is health care.Many battles remain, deputies, and lobby ministers. given the inevitable clashes between major What we achieved together was a major financial interests and basic human health needs? change of perspective: in the end, European We offer our congratulations to all those who legislators endorsed the view that medicines contributed to correcting the course of Euro- are not just another consumer good.The drafts pean legislation on medicinal products. And underwent major improvements, not least we stand shoulder to shoulder with all those ensuring greater transparency on the part of defending accessible, high-quality health care. medicines agencies. ©Prescrire International PRESCRIRE INTERNATIONAL AUGUST 2004/VOLUME 13 N° 72 • PAGE 158-1 Ouvertures e UROPE Translated from Rev Prescrire July-August 2004; 24 (252): 542-548. Medicines in Europe: citizens’ successes G The new European legislative uropean harmonisation on medici- ed extracts on Prescrire website, www. framework for human medicines was nal products started in the 1960s, prescrire.org). A joint position was published on 30 April 2004, after a Ewith the founding Directive finally adopted by the Council of procedure lasting more than two 65/65/EC. It continued over subsequent Ministers on 3 June 2003 (8). years. years, notably with the creation of the In late 2003, deputies and ministers European Medicines Evaluation Agency again came under pressure, notably from G The stakes were high, as the new in 1995 (1). the Enterprise Directorate-General and texts determine the level of After multiple additions and amend- industry representatives, to complete their guarantees offered to EU citizens on ments, two major texts, valid until 2003, work before the new member states joined marketing authorisation, risk set out the legislative framework for the Union. The last compromises, management and information on medicinal products: namely Directive adopted on 17 December 2003, were medicines. 2001/83/EC, instituting the community reached after hasty negotiations. code on medicines for human use G Patients, consumers, health (grouping together the provisions of As a result, the final Directive and professionals and health insurance previous Directives); and Regulation Regulation, published in the Official organisations joined forces, notably 2309/93, establishing community Journal of the European Union on within the Medicines in Europe procedures and creating the European 30 April 2004 (10,11), differ substantial- Forum, to make their views heard Medicines Evaluation Agency (2,3). ly from the initial drafts. We list the most and to act as a counterweight to the The European Commission, which important changes affecting patients and powerful pharmaceutical lobby. initiates legislative changes, presented health care professionals, comparing two drafts: one to replace the 2001 the new text with the previous wording, G The citizens’ lobby made several Directive, and one to replace the 1993 and pointing out the most negative pro- noteworthy gains, especially Regulation. The Enterprise Directorate- posals that were ultimately rejected (b). regarding medicines agencies’ General of the European Commission is transparency. But pharmaceutical responsible for matters relating to medic- majors, with support from the inal products. Its overriding aims were to Transparency of medicines agen- European Commission’s Enterprise make the European pharmaceutical cies: unprecedented obligations Directorate-General, succeeded in industry more competitive, and to ensure ensuring that the notion of “ added that the single European market contin- therapeutic value” will not be taken ued to function after EU expansion on The main change concerns transparency into account when considering 1 May 2004. The draft texts placed too obligations by medicines agencies, which whether or not to authorise new much stress on relaxing marketing was barely an issue in the previous texts. drugs, and that the “clinical data authorisation procedures and permitting protection period” will be even advertising, while largely overlooking National agencies: public access longer than before. public health concerns (1,4). to the agendas and reports of meet- ings, and to assessment reports. The G EU citizens must remain The European Commission had to Directive now requires that “member mobilised to ensure that the texts are revise its work. The two new texts were states shall ensure that the competent author- effectively enacted in national adopted through the co-decision proce- ity (i.e. the national medicines agency) makes legislation and are strictly applied in dure, involving the European Parliament publicly accessible its rules of procedure and patients’ best interests.We must also and the Council of Ministers (a). This those of its committees, agendas for its meet- be on the lookout for the tricks that procedure took more than two years, ings and records of its meetings, accompa- the drug companies will inevitably from late 2001 to early 2004 (1,4-9). nied by decisions taken, details of votes and employ to preserve their financial At the first reading by the European explanations of votes, including minority interests. Parliament, in 2002, deputies adopted opinions” (D article 126b). It further stip- many amendments intended to place the ulates that the competent authorities accent on public health, despite strong will make marketing authorisation pressure from the industry lobby (6). “publicly accessible”, “without delay”, Some European health ministers subse- together with the assessment report Medicines in Europe : quently rejected a number of amend- and the underlying reason for their ments they thought might undermine the opinion provided separately for each the complete file is funding of national medicines agencies indication (D articles 21-3 and 21-4). available free in or the financial interests of their coun- tries’ drug companies. Others rallied to The European agency: public French and English defend patients’ interest, but the deter- access to all documents underlying on www.prescrire.org mined European Commission continued decisions. In the 2004 Regulation, to support the industrial sector (see select- almost all the articles concerning deci- PAGE 158-2 • PRESCRIRE INTERNATIONAL AUGUST 2004/VOLUME 13 N° 72 sions made by the European Medicines staff (…) responsible for granti- Evaluation Agency and the documents ng marketing authorisation, underlying these decisions mention an rapporteurs and experts (…), have obligation to make these documents no financial or other interests in available to the public (see below for the pharmaceutical industry details of each of the agency’s core tasks). which could affect their impar- In addition, article 73 of the 2004 tiality. These persons shall make Regulation stipulates that European an annual declaration of their Regulation 1049/2001 on public access financial interests” (D article to documents held by European insti- 126b). tutions now applies to the medicines The 2004 Regulation states agency. The agency is therefore required that the financial interests of to create a “register (…) to make available members of the management all documents that are publicly accessible board, committee members, (…)”, as is already the case for other insti- rapporteurs and European tutions. These registers were created to Medicines Evaluation Agency make documents easily accessible, even experts must