PORTUGUESE OFFER TO THE EUROPEAN MEDICINES AGENCY (EMA) RELOCATION This is a courtesy translation into the English language. Only the text in the Portuguese language shall be authentic.

Official page in: http://www.emainporto.eu/ Portuguese Offer To The European Medicines Agency (EMA) Relocation

ÍNDEX

Executive summary

Institutional messages

Introduction

1. The assurance that the Agency can be set up on site and take up its functions at the date of the United Kingdom’s withdrawal from the Union

2. The accessibility of the location

3. The existence of adequate education facilities for the children of Agency staff

4. Appropriate access to the labour market, social security and medical care for both children and spouses

5. Business continuity

6. Geographical spread

Annex I - Macroeconomic background

Annex II - Technical features of the locations (confidential)

3 Portuguese Offer To The European Medicines Agency (EMA) Relocation

EXECUTIVE SUMMARY

PORTO, LOCATION OF EXCELLENCE Since joining the European Union in 1986, This is only possible thanks to the modern Portugal has been at the forefront of landmark infrastructure the city is endowed with, providing initiatives such as the Schengen area or the excellent access to Europe and to the rest of the Euro, of which it is a founding member. The world. The new headquarters of the European country's commitment to the European project Medicines Agency (EMA) will be located in is supported by the majority of the population, the Historic Centre of Porto, a UNESCO World and runs through political cycles. Heritage Site, in a modern building fulfilling all the necessary requirements for the Agency to be Being the westernmost country in Europe, with fully operational. the same time zone as the United Kingdom, Portugal has a privileged geographic location Francisco Sá Carneiro airport, with an annual to act as an intercontinental platform, bridging passenger volume of around 9.4 million is a state- the gap between Europe, America and Africa. of-the-art infrastructure, whose quality has been Additionally, Portuguese is the official language distinguished by several international awards. It in four continents, thus being a language with is only 15 Km away from the city centre, and is more than 260 million speakers worldwide. easily and rapidly accessible by car, bus or metro.

The city of Porto embodies the Portuguese tradition of openness and tolerance, presenting itself as a hub of excellence for the meeting of people coming from the four corners of the world.

4 Portuguese Offer To The European Medicines Agency (EMA) Relocation

PORTO, PRESENT AND FUTURE OF EMA The economic, social, scientific and The dynamics of growth, recognition and technological context of Portugal and the city of competitiveness of Research and Development Porto are guarantees of the continuity of EMA's (R&D), both in Portugal and Porto, in particular in business, while ensuring the attractiveness to the the health sector, is a guarantee for the training current, and future, staff and their families. and recruitment of highly qualified human resources, necessary for the work of EMA. There To ensure an effective transition, INFARMED, are 117 R&D public and private institutions, in the national regulator of medicines, with a health sciences, in Porto's area of influence, with remarkable and long-standing partnership with the University of Porto being the largest scientific EMA, will have in place the human, scientific producer regarding biomedical sciences and and technical resources to strengthen their health, in national terms. collaboration with the Agency. Additionally, the business sector in the health Portugal is a country that offers an undeniable sector has been expanding in Portugal, with quality of life for running an individual project more than 47,000 companies in life sciences or family life, being recognised by its stability, only in Porto's area of influence. its features in the domains of health and environment, by its given natural qualities, by its Portugal shows a growing trend towards the touristic, cultural and leisure offer, and - last but qualification of its population, as well as the not least - its hospitality. internationalization of its education system. There are about 700 courses offered in English, The Portuguese economy is now in solid 186 of which in Porto. Portugal also ranks 12th in expansion and in a sustained and long-lasting the English Proficiency Index 2016. cycle of convergence with the European Union. Growth during the current year should be higher 2%, above the European average, and surpassing the most recent forecasts by national and international institutions.

5 Portuguese Offer To The European Medicines Agency (EMA) Relocation

PORTO, THE ART OF HOSPITALITY

The Agency’s ability to take of its functions in the labour market for spouses. involves the existence of irreproachable quality facilities, as well as ensuring a smooth transition With regard to the adequate education for EMA staff and their families. facilities for the children of agency staff, Porto has a diversified educational offer, which will At the forefront of administrative modernization have 3.000 vacancies in September 2018 (and a physical (located initially in London) and digital expanding in the following years), in international infrastructure, will assist EMA staff and their schools of quality, among them the recognised families in the transition and settlement in the Porto British School, the oldest British school In city of Porto. This One Stop Shop for the hosting Continental Europe (1894). will be available during and after the relocation of EMA, covering areas such as: the management Portugal also offers a Welcome Package for of formalities in the establishment of residence the family members of the Agency staff, which and installation; information on the educational includes an attractive tax regime; job search offer in Portugal, recognition of equivalencies support; social security; and access to health and support in transition to portuguese schools; care. "Health concierge" service; and quick integration

6 Portuguese Offer To The European Medicines Agency (EMA) Relocation

PORTO, THE STRENGTHENING OF TERRITORIAL COHESION

Portugal has extensive experience in hosting same time, this constitutes an opportunity for the European and international organisations. promotion of decentralization at national level, by It is therefore able to conclude a headquarters strengthening cohesion and the enhancement agreement, which enshrines the advantageous of the territory by bridging the gap between conditions offered to EMA and its staff. citizens and the European project.

The location in Porto will bring EMA closer to one of its main partners, the European Monitoring Centre for Drugs and Drug Addiction. At the

7 INSTITUTIONAL MESSAGES Portuguese Offer To The European Medicines Agency (EMA) Relocation

The Portuguese Government has decided In recent years, Portugal has reached levels of to offer the city of Porto to the relocation of excellence in higher qualifications, scientific the headquarters of the European Medicines production and internationalization of knowledge- Agency (EMA). Porto is an extraordinary city, producing institutions, strengthening the relations which holds all the conditions to answer to the between these institutions and the business level of demand of the work carried out by EMA, community, so that the knowledge can function as well as to ensure the quality of life of its staff as a real engine for innovative and technological and their families. development.

Besides its exceptional climate, gastronomy We believe that scientific capital and priority and hospitality, complemented by a diversified given to knowledge and innovation are key for cultural offer, Portugal is recognized nowadays as the future of EMA. Portugal wants EMA to be a country endowed with excellent infrastructures, an integral part of this national and European being the city of Porto connected to the whole of strategy and places itself in the pole position to Europe and the World through a strong transport reinforce its growth. and telecommunications network.

Due to Portugal's strategic investment on a new model of development, Porto has important António Costa centers of knowledge, science and innovation Prime Minister that enable EMA’s quality of work and activities. The country has strongly invested in research and development as a way of ensuring sustainable economic growth and a more cohesive society.

9 Portuguese Offer To The European Medicines Agency (EMA) Relocation

The European Medicines Agency (EMA) is one Portugal is strongly committed to this process of the most relevant agencies in the European having as essential reference the deepening of Union. In the ongoing relocation process priority safety and quality of life of European citizens in should be given to a transition that ensure the the domains of access and regulation of health best conditions for the business continuity of the technologies. Agency, without compromising the excellence of the work developed so far.

The city of Porto has privileged conditions to Adalberto Campos Fernandes host EMA, given the concentration of relevant Minister of Health technical and scientific resources, in the sector of health, in different domains – education, training and research.

The region hosts several institutions that combine excellence in health care, biomedical research and technological innovation with a dynamic social and economic environment, reconciling the best working and safety conditions with high standards of quality of life.

10 Portuguese Offer To The European Medicines Agency (EMA) Relocation

Porto is a two-thousand-year old city, one of the Porto a port of talent and skills for the XXI century eldest in Europe, recognised as world heritage economy. As Mayor, I would be delighted to site by the UNESCO since 1996. Over the two welcome the EMA to Porto. I can assure the millennia its citizens have developed a unique Agency of every assistance and cooperation in capacity of resilience which allowed them to making its move a successful one. always answer the most demanding challenges with innovative solutions that have luckily preserved much of its heritage. Rui Moreira Currently Porto’s reputation as an innovative city The Mayor of Porto is primarily due to its cultural features which are as much differentiating attributes, as they are essential to the urban quality of life. They are also one way of making the city known to the World. Porto is in fact an open city with a vibrant cultural life, a resurgent entrepreneurial scene, a world class university, and a unique City Centre which carries a culture of diversity in its genes.

This unusual capacity of combining our cultural heritage with innovation gave origin to a set of unique projects for the city, aiming to make

11 Portuguese Offer To The European Medicines Agency (EMA) Relocation

12 Portuguese Offer To The European Medicines Agency (EMA) Relocation

INTRODUCTION

Following the United Kingdom’s decision to withdraw from the European Union, the need for relocation of the European agencies based in London, the European Medicines Agency (EMA) and the European Banking Authority (EBA), arises. Considering that the required conditions for its hosting are met, Portugal has decided to offer the city of Porto to the hosting of EMA’s headquarters.

The Portuguese offer, presented in detail in the following chapters, demonstrates the country´s continuous commitment to the European project and its development. Europe is a key part of Portugal and its democratic identity. Portugal’s commitment to the European Union is widespread across its society, from political decision-makers to the citizens, of which 79% say they feel themselves European citizens. This reading places the country well above the European average (67%) and establishes Portugal as one of the most pro-EU members in the Union.

Portugal deeply believes in the large benefits of belonging to the European Union and following its values. Since joining the EU, more than 30 years ago, the country has been in the frontline of some of the main landmarks of the European project, such as the Schengen area, or the Euro area, of which it is a founding member.

The Portuguese commitment towards the European Union is clearly evident in the way it has steered its three European Union Council presidencies, in 1992, 2000, and 2007. During these three presidencies, Portugal obtained significant achievements for the history of the European integration.

13 Portuguese Offer To The European Medicines Agency (EMA) Relocation

For example, in 1992, the European Economic Area Agreement (EEA) between the European Community and the European Free Trade Association, was signed in Porto, the candidate city to host EMA. It is precisely in the EEA that EMA carries out its mission of protecting and promoting public and animal health.

The political agreement that led to the approval of the then called «New System» and to the creation of the European Medicines Agency itself was also reached during the first Portuguese presidency, in 1992. This milestone shows the active and engaged involvement of the Portuguese authorities in the construction, development, and consolidation of a European system for medicines. Portugal’s commitment, through its national medicines regulator, INFARMED, I.P., is well established and still maintains its top position regarding the procedures of evaluation of medicines as well as in the coordination of EMA’s committees and working groups.

The following Portuguese presidencies also achieved other successes, such as, in year 2000, the preparatory work for the development of an economy based on knowledge - nowadays still at the top of the European concerns - or the signature, in 2007, of the Lisbon Treaty, an essential milestone in the recent history of the European integration.

Portugal’s action in the European Union is driven towards the domestic policies, as well as to the external dimension of the EU. It was under Portuguese EU presidencies that the first EU-Africa, EU- India, and EU-Brazil summits took place, which are an example of the Portuguese commitment to Europe’s political, economic, and cultural rapprochement to other regions.

Portugal’s proactive position shown in the Union’s external dimension mirrors a centuries-old history of openness to the world, but also a privileged geographical position, which enables the country to play a role as an intercontinental platform. Bearing in mind the several international actors relevant for the medicines sector, Portugal’s geographical position is a natural added value available for EMA’s activity.

Other than the country’s geographical location, in Portugal, EMA will also benefit from a headquarters of excellence in Porto. Nowadays, the region of Porto is more and more acknowledged as a privileged location for industry, innovation, investment, and tourism. Recently, the city of Porto was considered the third best city in the South of Europe for investment (FDI Intelligence) and was awarded with the distinction of European Best Destination 2017 (ACI). These are some examples of the unique conditions that Porto offers, not only in terms of the Agency’s operations in Portugal, but also on what concerns the excellent living standards provided for its staff and their families.

In line with the Commission guidelines with standard provisions for headquarters agreements of EU decentralised agencies and the legal instruments signed with the agencies already located in the country, Portugal will sign with EMA a headquarters agreement, before its relocation to the national territory, covering all the offered benefits and stated throughout this candidature.

14 Portuguese Offer To The European Medicines Agency (EMA) Relocation

Portugal’s commitment to the European project, the experience in hosting other European agencies (European Monitoring Centre for Drugs and Drug Addiction and the European Maritime Safety Agency) and international organizations, together with the natural and institutional conditions offered to EMA, enable Portugal to fulfil the criteria endorsed by the European Council on June 22, thus presenting an ideal location for the relocation of this important European agency.

15 Portuguese Offer To The European Medicines Agency (EMA) Relocation

1. THE ASSURANCE THAT THE AGENCY CAN BE SET UP ON SITE AND TAKE UP ITS FUNCTIONS AT THE DATE OF THE UNITED KINGDOM’S WITHDRAWAL FROM THE UNION To identify the best location for EMA in Porto, a set of options were analysed in detail, which resulted in three location proposals considered as the most appropriate for the relocation of EMA. These proposals are presented below.

The first proposed location is the Palácio Atlântico building, located in Praça D. João I. The second one is the Palácio dos Correios building, located in Avenida dos Aliados. The third offer is to be built in a plot located in Avenida Camilo Castelo Branco.

The main parameters considered in the selection process included the functional and technical requirements established for EMA’s relocation, the potential site expension and the relocation timeframe. The table below allows a comparison between the three different location proposals.

The buildings are locatated in central Porto, served by a dense network of services and urban equipment, shops, hotels, restaurants, public parking lots, gardens, and regenerated heritage areas, together with many national and international business companies.

16 Portuguese Offer To The European Medicines Agency (EMA) Relocation

All these three locations are in the most cosmopolitan area of the city, close to its UNESCO World 1. THE ASSURANCE THAT THE AGENCY CAN BE SET UP ON SITE AND Heritage Centre and its service centre, yet not far from the best residential areas. TAKE UP ITS FUNCTIONS AT THE DATE OF THE UNITED KINGDOM’S WITHDRAWAL FROM THE UNION Any of the three options is easily accesible by metro, with stations less than three minutes away, thus To identify the best location for EMA in Porto, a set of options were analysed in detail, which resulted connecting to the whole city and to main infrastructure such as the airport, universities, hospitals and in three location proposals considered as the most appropriate for the relocation of EMA. These other equipment in the metropolitan area. proposals are presented below.

Urban and inter-city road and railway network are also within close reach. The first proposed location is the Palácio Atlântico building, located in Praça D. João I. The second one is the Palácio dos Correios building, located in Avenida dos Aliados. The third offer is to be built in a plot located in Avenida Camilo Castelo Branco. The three proposed locations are immediately available for EMA’s relocation, since they have planned works already in the design phase. The main parameters considered in the selection process included the functional and technical requirements established for EMA’s relocation, the potential site expension and the relocation timeframe. The table below allows a comparison between the three different location proposals. In all cases, it is fully feasible to start the adaptation works of the existing buildings immediately, as well as the construction of the new premises for EMA, so that the process can be completed by the scheduled date of March 2019, as shown in the respective chronograms. The buildings are locatated in central Porto, served by a dense network of services and urban equipment, shops, hotels, restaurants, public parking lots, gardens, and regenerated heritage areas, together with many national and international business companies. The availability of premises with the features required by EMA, namely regarding auditoriums, meeting rooms, reception space, cafeterias, archives and other special facilities, is fully compatible with the current state of the three buildings, which the Municipality already took the initiative to revise in coordination with the respective owners.

17 Portuguese Offer To The European Medicines Agency (EMA) Relocation

In these three proposals, the owners of each property agreed to receive EMA, changing the buildings original purposes, guaranteeing their financing and leasing contract under the most favourable conditions for EMA: with rental prices between €16 and €18 per square meter, without any additional charges for the tenant: as the prices already include building management and maintenance services. For the three locations, a grace period is also foreseen for the first 12 months after the relocation of the Agency.

The Municipality of Porto will bear the costs of structuring high-speed internet connections to any of the locations through the Porto Digital network.

Costs for the future upgrade of the buildings, in addition to the proposals presented, will be negotiated between the Agency and the owners.

Table 1 (a) Comparison between the different location proposals

Praça D João I /Palácio Aliados / Palácio dos Proposal conditions Avenida Camilo Atlântico Correios Type of construction/ Adaptation of existing Adaptation of existing New renovation works buildings and extension buildings and extension construction Total area (m2) 29, 536 29, 939 29, 900 Current available area (m2) 20, 665 24, 000 0 Extension area (m2) 8, 871 5, 939 29, 900 Possibility of future Ye s Ye s Ye s extension Compliance with technical Yes (see Annex Yes (see Annex II-1) Yes (see Annex II-2) requirements II-3) Duration of construction/ renovation works (from Nov. 14 months 12 months 14 months 2017) 16 €/m2/ Financial conditions 18 €/m2/month 18 €/m2/month month

18 Portuguese Offer To The European Medicines Agency (EMA) Relocation

1.1. PALÁCIO ATLÂNTICO

Palácio Atlântico is a major landmark of an iconic square in the city centre, where the Rivoli Theatre (Municipal auditorium) is located. It was built in the middle of the 20th century to house one of the most important Portuguese banks, Banco Português do Atlântico. Whether from an urban, or artistic point of view, the building is a refence of the international architecture style in the city of Porto.

Palácio Atlântico is part of a block that is currently subject to an integrated urban regeneration strategy (ARU-Aliados), and therefore offers great possibilities not only for renovating the existing building, but also for new constructions, which can house the most demanding facilities of EMA large size, high ceilings or special features.

In this way, the complex formed by the existing building and the new areas to be built provides the new EMA headquarters the best conditions in terms of functionality, immediate availability and urban integration.

19 Portuguese Offer To The European Medicines Agency (EMA) Relocation

The block where this building is located is next to Bolhão Market, one of the landmarks of Porto, as well as the main streets and squares in the city.

Implementation chronogram - D. João I/Palácio Atlântico

2017 2018 2019 Phases 7 8 9 10 11 12 1 2 3 4 5 6 7 8 9 10 11 12 1 2 3 Studies Architecture design Technical specification analysis Relocation Demolition Contentions and excavations Structures Building construction Finishing works Equipment

1.2. PALÁCIO DOS CORREIOS

Palácio dos Correios, located on the main avenue of the city and opposite to City Hall, is a modern building with great architecture designed by Carlos Ramos, one of the most famous architects of the renowned Architecture School of Porto.

This building occupies a whole block designed for services, with an immediate availability of spaces. It also has potential for expansion, both for the part of the building that is still in use and the new building to be constructed on the available plot.

The functional change of the existing building, which is to a large extent empty, is eased by its structural features and does not face any constraints that could delay the relocation.

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Implementation chronogram - Aliados/Palácio dos Correios

2017 2018 2019 Fases 7 8 9 10 11 12 1 2 3 4 5 6 7 8 9 10 11 12 1 2 3 Studies Architecture design Technical specification analysis Relocation Demolition Contentions and excavations Structures Building construction Finishing works Equipment

21 Portuguese Offer To The European Medicines Agency (EMA) Relocation

1.3. AVENIDA CAMILO

The project for this site is developed on plots located in the central area of the city, previously occupied by two large industrial facilities, allowing the construction of buildings and large patios in perfect harmony with the two surrounding streets.

All pre-existing structures are currently being demolished and can therefore be made available immediately with conditions that can fully satisfy the Agency's needs within the required timeframe.

This site is also part of an urban regeneration area (ARU-Bonfim) and is currently the preferred location by several multinational companies which are planning to set up their operations in Porto.

Implementation chronogram - Av. Camilo

2017 2018 2019 Fases 7 8 9 10 11 12 1 2 3 4 5 6 7 8 9 10 11 12 1 2 3 Studies Architecture design Technical specification analysis Relocation Demolition Contentions and excavations Structures Building construction Finishing works Equipment

22 Portuguese Offer To The European Medicines Agency (EMA) Relocation

The technical characteristics of the location proposals are detailed in Annex II.

1.4. IT INFRASTRUCTURE, TELECOMMUNICATION NETWORK AND DATA CENTRE

Portugal has international and local IT providers for Data Centre Networks capable of offering EMA the technological services to match its needs, displaying excellent internet and fibre connections, with broadband covering nearly 100% of households.

In Portugal, EMA will also have tier-3 data centres, complying with green energy standards ISO 14001 and 50001, security and operational ISO standards.

Portugal has a high quality IT infrastructure and Porto is one of the most competitive, innovative and creative cities in Europe, with a thriving digital ecosystem, a dynamic environment for business creation and an increasingly qualified international labour force.

All over the country there is widespread fixed and mobile broadband services, both in public and private sectors. Portugal’s state of art digital and communications technology was ranked 7th among in 61 economies (IMD- World Competitiveness Yearbook 2016).

Portugal’s performance in Digital Public Services remains well above the EU average (EU Goverment Benchmark 2016), with new initiatives enabling business efficiency and easing people’s lives. Electronic medical prescriptions are just an example.

Above average connectivity (DESI 2017 – Digital Economy and Society Index) is the major enabler for this fast adoption of digital technologies, with Portugal ranking 8th in broadband availability, 6th in 4G coverage and 4th in fast broadband subscriptions.

Finally, since the task of renting/building a dedicated institutional data centre is affected by the risks of natural disasters and associated damages, data centre facilities need to assure the maximization of employee safety and a reduced risk of downtime during seismic activity. According to the European Archive of Historical Earthquake Data from AHEAD, the city of Porto, belonging to the Northern Region, does not have any historical record of significant earthquakes.

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Portuguese Offer To The European Medicines Agency (EMA) Relocation

2. THE ACCESSIBILITY OF THE LOCATION

Due to its geographic location, and due to its tradition of openness and tolerance, Portugal is a hub of excellence for the meeting of peoples from the four corners of the world. The city of Porto has transport infrastructure and accommodation capacity with quantity and quality levels necessary for the continuation of the volume and intensity of current meeting activities of the Agency.

2.1. FLIGHT CONNECTIONS

The city is endowed with airport infrastructures of renowned international quality: Sá Carneiro airport has received the 2016 Airport Service Quality (ASQ) Awards for infrastructures of 5-15-million passenger size. With a passenger volume of 9,4-million passengers, Porto has regular direct flights to 81 different airports, located in 72 cities of 22 countries.

The existing one-hour air-bridge with Lisbon (Humberto Delgado airport) allows Porto to complement and scale-up its airport capacity, additionally connecting the city to 118 airports, located in 106 cities of 39 different countries, encompassing 4 continents.

26 Portuguese Offer To The European Medicines Agency (EMA) Relocation

2. THE ACCESSIBILITY OF THE LOCATION The city is thus connected to all of Europe. EU Member-State capitals can be reached within an average of 4 hours. Due to its geographic location, and due to its tradition of openness and tolerance, Portugal is a hub of excellence for the meeting of peoples from the four corners of the world. The city of Porto has transport infrastructure and accommodation capacity with quantity and quality levels necessary for the continuation of the volume and intensity of current meeting activities of the Agency.

2.1. FLIGHT CONNECTIONS

The city is endowed with airport infrastructures of renowned international quality: Sá Carneiro airport has received the 2016 Airport Service Quality (ASQ) Awards for infrastructures of 5-15-million passenger size. With a passenger volume of 9,4-million passengers, Porto has regular direct flights to 81 different airports, located in 72 cities of 22 countries.

The existing one-hour air-bridge with Lisbon (Humberto Delgado airport) allows Porto to complement and scale-up its airport capacity, additionally connecting the city to 118 airports, located in 106 cities of 39 different countries, encompassing 4 continents.

27 Portuguese Offer To The European Medicines Agency (EMA) Relocation

Tabela 2 (a) Flights to EU Capitals

EU Capitals Number of weekly flights Flight duration1 Amsterdam 24 02h08 Athens Daily (with connecting flights) 05h10 (with connecting flights) Berlin 4 03h03 04h05 (connecting flight via Bratislava 2 (connecting flight via Vienna) Vienna) Brussels 34 02h00 Bucharest Daily (with connecting flights) 05h12 (with connecting flights) Budapest 2 03h21 Copenhagen 3 03h14 Dublin 6 02h20 Helsinki Daily (with connecting flights) 05h35 (with connecting flights) Lisbon 140 00h37 Ljubljana Daily (with connecting flights) 05h35 (with connecting flights) London 58 02h15 Luxembourg 21 02h00 Madrid 69 00h46 Nicosia Daily (with connecting flights) 08h25 (with connecting flights) Paris 102 01h42 Prague 3 02h59 Riga Daily (with connecting flights) 05h45 (with connecting flights) Rome 3 02h35 Sofia Daily (with connecting flights) 04h55 (with connecting flights) Stockholm 2 03h56 Tallinn Daily (with connecting flights) 05h50 (with connecting flights) Valetta Daily (with connecting flights) 07h25 (with connecting flights) Vienna 2 03h05 Vilnius Daily (with connecting flights) 05h25 (with connecting flights) Warsaw 7 03h40 Zagreb Daily (with connecting flights) 05h00 (with connecting flights)

[1] Flight duration with the note “with connecting flights” include the extra hour of the air-bridge via Lisbon.

Source: Portuguese Ministry of Planning and Infrastructure; Municipality of Porto; Porto Tourism Association

EMA’s work is based on the knowledge of 3,700 experts from the entire European Union. The national regulators of medicines, including those from the European Economic Area, play a key role in the Agency’s work. It should be noted that some regulators are not located in the EU Member-States capitals.

28 Portuguese Offer To The European Medicines Agency (EMA) Relocation

Tabela 2 (b) Flights to the locations of the EEA’s National Regulators Destinations within EEA Number of weekly flights Flight duration1 National Regulator Athens Daily (with connecting flights) 05h10 (with connecting flights) National Organization for Medicines Bonn (Cologne-Bonn Airport) 5 04h10 (with connecting flights) Federal Institute for Drugs and Medical Devices 2 (connecting flight via 04h05 (connecting flight via Bratislava State Institute for Drug Control Vienna) Vienna) Federal Agency for Medicines and Health Brussels 34 02h00 Products Bucharest Daily (with connecting flights) 05h12 (with connecting flights) National Medicines Agency Budapest 2 03h21 National Institute of Pharmacy and Nutrition Copenhagen 3 03h14 Danish Medicines Agency Dublin 6 02h20 Health Products Regulatory Authority Gżira (Valletta) Daily (with connecting flights) 05h25 (with connecting flights) Medicines Authority Helsinki Daily (with connecting flights) 05h35 (with connecting flights) Finnish Medicines Agency Langen (Frankfurt) 28 04h11 (with connecting flights) Paul Ehrlich Institute National Authority of Medicines and Health Lisbon 140 00h37 Products Agency for Medicinal Products and Medical Ljubljana Daily (with connecting flights) 05h35 (with connecting flights) Devices of the Republic of Slovenia Medicines and Healthcare products Regulatory London 58 02h15 Agency Luxembourg 21 02h00 Ministry of Health Spanish Agency for Medicines and Health Madrid 69 00h46 Products Nicosia Daily (with connecting flights) 08h25 (with connecting flights) Ministry of Health - Pharmaceutical Services Oslo Daily (with connecting flights) 04h50 (with connecting flights) Norwegian Medicines Agency National Agency for the Safety of Medicine and Paris 102 01h42 Health Products Prague 3 02h59 State Institute for Drug Control Reykjavík Daily (with connecting flights) 06h25 (with connecting flights) Icelandic Medicines Agency Riga Daily (with connecting flights) 05h45 (with connecting flights) State Agency of Medicines Rome 3 02h35 Italian Medicines Agency Sofia Daily (with connecting flights) 04h55 (with connecting flights) Bulgarian Drug Agency Stockholm 2 03h56 Medical Products Agency Tartu Daily (with connecting flights) 13h30 (with connecting flights) State Agency of Medicines Utrecht 24 02h08 Medicines Evaluation Board Utrecht 24 02h08 Healthcare Inspectorate 28 (connecting flight via Vaduz 02h30 Office of Health / Department of Pharmaceuticals Zürich) Vienna 2 03h05 Austrian Agency for Health and Food Safety Vilnius Daily (with connecting flights) 05h25 (with connecting flights) State Medicines Control Agency Office for Registration of Medicinal Products, Warsaw 7 03h40 Medical Devices and Biocidal Products Warsaw 7 03h40 Chief Pharmaceutical Inspectorate Agency for medicinal products and medical Zagreb Daily (with connecting flights) 05h00 (with connecting flights) devices of Croatia

[1] Flight duration with the note “with connecting flights” include the extra hour of the air-bridge via Lisbon.

Source: Portuguese Ministry of Planning and Infrastructure; Municipality of Porto; Porto Tourism Association

From Porto, there are also several air routes to different parts of the world, making it easy for EMA’s international stakeholders to come and go (4,000 visitors outside the EEA).

29 Portuguese Offer To The European Medicines Agency (EMA) Relocation

Tabela 2 (c) Flights to locations outside the EEA

Destinations outside EEA Number of weekly flights Flight duration from Porto Australia Daily (with connecting flights) Porto - Sydney (26h20 with connecting flights) Brazil 4 Porto - São Paulo (10h40) Canada 6 Porto - Toronto (7h55) China Daily (with connecting flights) Lisbon - Beijing (12h25); Porto +1h India Daily (with connecting flights) Porto – New Delhi (11h25 with connecting flights) Israel Daily (with connecting flights) Lisbon - Tel Aviv (5h30); Porto +1h Japan Daily (with connecting flights) Porto - Tokyo (15h25 with connecting flights) Russia Daily (with connecting flights) Lisbon - Moscow (5h20); Porto +1h South Korea Daily (with connecting flights) Porto - Seoul (15h00 with connecting flights) Switzerland 97 Porto - Geneva (2h10) USA 2 Porto – New York (08h05)

Source: Portuguese Ministry of Planning and Infrastructure; Municipality of Porto; Porto Tourism Association

2.2. TRANSPORTATION BETWEEN THE AIRPORT AND THE NEW EMA HEADQUARTERS

The privileged location of the Porto airport, just 15 km away from the city centre, allows a passenger to get to the new EMA premises in about 30 minutes (see location in chapter 1), whatever the transportation option made - metro, bus or taxi - even at rush hour.

Tabela 2 (d) Transportation between the airport and the new EMA headquarters Transportation between the airport and the new Palácio Atlântico/Palácio dos Correios Avenida Camilo EMA headquarters Taxi / car Average duration of the trip between the airport and 00h25 00h25 new EMA HQ, at rush hour Bus Number of lines between the airport and new EMA 2 N/A HQ Frequency of direct lines between the airport and 00h25 N/A new EMA HQ, at rush hour Average duration of the trip between the airport and 00h35 N/A new EMA HQ, at rush hour Metro Number of direct lines between the airport and new 1 1 EMA HQ (without switching to other lines) Distance between the airport and new EMA HQ 16 18 (number of stations) Frequency of direct lines between the airport and 00h15 00h15 new EMA HQ, at rush hour Average duration of the trip between the airport and 00h27 00h30 new EMA HQ, at rush hour

Source: Municipality of Porto

Porto has a wide, modern and reliable public transportation network. For example, the metro (with stations designed by the Pritzker Prize winner Souto Moura), received the Light Rail Award 2008 and

30 Portuguese Offer To The European Medicines Agency (EMA) Relocation

the Veronica Rudge Green in Urban Design 2013; the bus network is the largest in the world with WI- FI, running mostly (55%) on natural gas.

Tabela 2 (e) Some data on Porto’s public transportation

Metro Bus 67km of length 74 lines 81 metro stations 500 vehicles

Fonte: Municipality of Porto

2.3. HOTEL CAPACITY

In 2016, Porto had 1,426,863 visitors, which resulted in 2,833,406 hotel nights. According to PwC, in 2017 and 2018, Porto will be the European city with the biggest growth in RevPar terms (Revenue per Available Room).

As a business centre and tourism destination of excellence, Porto has a vast hotel offer, which allows the city to accommodate EMA’s 36,000 annual visitors and to cope with a daily peak hotel capacity of 350 rooms.

Tabela 2 (f) Porto’s accommodation capacity

Aliados (Palácio Atlântico/Palácio dos Accommodation capacity Avenida Camilo Correios) Number of available rooms in

hotels in the city 5 stars 1,305 4 stars 2,421 3 stars 1,203 Number of available rooms in hotels within 1 km from EMA (“walking distance”) 5 stars/4 stars 1,185 827 3 stars 515 336

Source: Portuguese Ministry of Planning and Infrastructure; Municipality of Porto; Porto Tourism Association

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3. THE EXISTENCE OF ADEQUATE EDUCATION FACILITIES FOR THE CHILDREN OF AGENCY STAFF

The wide and diversified network of schools in the Porto area will ensure a tailor made, swift and smooth transition to all the children of Agency staff.

3.1. THE EDUCATIONAL OFFER IN PORTO

If EMA is relocated to Porto, the Agency staff will have several multi-lingual, international and European-oriented education facilities available. This offer consists primarily of international schools established in Porto, where courses are taught in the three working languages of the European Commission – English, French and German.

32 Portuguese Offer To The European Medicines Agency (EMA) Relocation

Table 3 (a) Short description of the international schools established in Porto 3. THE EXISTENCE OF ADEQUATE EDUCATION FACILITIES FOR THE CHILDREN OF AGENCY STAFF Lycée Français International de Porto (LFIP) Established in 1963, LFIP covers all education levels from pre-school to secondary education. As part of the global The wide and diversified network of schools in the Porto area will ensure a tailor made, swift and network of the AEFE (Agence pour l’enseignement français à l’étranger), this school provides intensive French language smooth transition to all the children of Agency staff. teaching, in line with the programmes designed by the French Government. Its diploma has wide international recognition. Deutsche Schule zu Porto Established in 1901, the German School of Porto is part of a network of 130 German schools abroad (Deutsche 3.1. THE EDUCATIONAL OFFER IN PORTO Auslandsschulen International). This school provides a complete range of education to students, from kindergarten to secondary school, namely allowing them to pursue their studies in Germany. Porto British School If EMA is relocated to Porto, the Agency staff will have several multi-lingual, international and Established in 1894, this is one of the oldest international schools in the world, and the oldest British school in Continental Europe. The school provides an international education for students from ages 3 to 18. European-oriented education facilities available. This offer consists primarily of international schools established in Porto, where courses are taught in the three working languages of the European Colégio Luso-Internacional do Porto (CLIP) Commission – English, French and German. Established in 1990, CLIP has students, aged 3 to 18, from 34 different countries. CLIP follows the English national curricula, with local adjustments. It is accredited by the Council of International Schools. Colégio EFANOR Established in 2008, this private school stands out for its innovative teaching methods and strong focus on foreign language teaching – English and Spanish. Its offer currently ranges from nursery to primary school, but in the future it will be extended to secondary education.

33 Portuguese Offer To The European Medicines Agency (EMA) Relocation

The international education facilities located in Porto, which provide high-quality education, can meet the needs for education facilities for the children of the current staff, in a timely fashion. Indeed, these international schools’ are capable of accommodating the demand at the time of EMA’s relocation to Portugal, as detailed in the table hereafter.

Table 3 (b) Capacity of international schools in Porto, in September 2018 and September 2019

Children of the current EMA staff, divided School Level September 2018 September 2019 by age group 117 children between 0-3 years old + 96 Nursery + Pre-school 538 630 children between 3-5 years old (as of July 2016) 1st cycle Primary + 2nd 231 children between 5-11 years old (as of July 1,201 1,406 cycle Primary 2016) 3rd cycle Primary + 149 children between 11-18 years old (as of 1,272 1,489 Secondary July 2016)

TOTAL 3,011 3,525 593

Source: Portuguese Association of Private and Cooperative Education Facilities (AEEP), Municipality of Porto

The members of EMA staff who wish to do so can also enrol their children in the Portuguese educational system, which can thus complement the offer of the international schools in the city. It must be pointed out that Portuguese national curricula place considerable emphasis on the teaching of foreign languages.

The Portuguese Government guarantees free access to all pre-school education facilities belonging to the public (or funded) network, to all the children of EMA staff who wish to do so. Free access to the public school network is also ensured, from the beginning of primary school until the end of secondary school, in any of its options (scientific / humanistic / or vocational education), in any establishment near the staff member’s area of residence (or work).

34 Portuguese Offer To The European Medicines Agency (EMA) Relocation

Table 3 (c) Current number of students attending public schools in the Porto Metropolitan Area

Children of the current EMA staff, divided by School Level Porto Metropolitan Area age group

Pre-school 21,262 96 children between 3-5 years old (as of July 2016)

1st cycle + 2nd cycle Primary 231 children between 5-11 years old (as of July 86,912 School 2016) 3rd cycle Primary School + 149 children between 11-18 years old (as of July 75,978 Secondary School 2016)

Source: Ministry of Education

In addition to the network of public schools, a vast range of private education facilities is available, thus increasing the number of vacancies by about 50%.

Table 3 (d) Number of students attending public and private schools in the Porto Metropolitan Area (2014/2015)

Porto Metropolitan School Level Children of the current EMA staff, divided by age group Area

Pre-school 44,259 96 children between 3-5 years old (as of July 2016)

1st cycle + 2nd cycle Primary 108,402 231 children between 5-11 years old (as of July 2016) School 3rd cycle Primary School + 135,073 149 children between 11-18 years old (as of July 2016) Secondary School

Source: Directorate-General for Education and Science Statistics of Portugal

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3.2. A SINGLE INTERFACE WITH THE SCHOOL NETWORK

Whatever the preference of EMA staff members is – international schooling or Portuguese schooling –, additional information will be available to help them select the best option, as well as support to complete the necessary proceedings for their children’s enrolment, through the centralised “Balcão Único” (One-Stop-Shop) (see chapter 4).

Through the Ministry of Education, the Portuguese Government will put together a team with the purpose of liaising with EMA staff, composed of specialised and certified English-speaking technicians. This team will ensure: the facilitation and follow up on the processes of information and selection of the children’s educational careers; school enrolment; the accreditation of prior education; and the granting of curriculum equivalencies. The team’s dimension will be determined according to the needs imposed by the Agency’s relocation procedures, so that a timely answer is given to the simultaneous relocation of all staff members.

3.3. HIGHER EDUCATION OFFER, ALSO IN ENGLISH

Portugal is increasingly becoming a destiny of choice for university students. Between 2009 and 2016, the number of foreign students attending Portuguese universities almost doubled, representing already 12% of the total university students of the country. The high quality of Portuguese universities, validated by international rankings (such as the Financial Times, the Shanghai ranking, or the Times Higher Education), and the huge increase in scientific output have been decisive attractiveness factors for the Portuguese higher education system.

36 Portuguese Offer To The European Medicines Agency (EMA) Relocation

The amount and variety of courses provided in English has been another crucial factor in the attraction of more foreign students. According to the data provided by the Ministry of Science, Technology and Higher Education, available for the academic year of 2014-2015, Portugal offers an average of 700 higher education courses (bachelor, masters degrees and PhD) delivered in English, 186 of which in Porto.

Table 3 (e) University courses totally or partially taught in English in Porto

Bachelor Master MBA PhD Total Agriculture & Forestry 0 1 0 1 2 Applied Sciences & Professions 0 1 0 1 2 Arts, Design & Architecture 2 6 0 5 13 Business & Management 6 13 2 2 23 Computer Science & IT 2 8 0 7 17 Education & Training 0 0 0 0 0 Engineering & Technology 1 9 0 17 27 Environmental Studies & Earth 1 1 0 4 6 Sciences Hospitality, Leisure & Sports 2 1 0 1 4 Humanities 1 1 0 0 2 Journalism & Media 0 1 0 0 1 Law 2 3 0 0 5 Medicine & Health 1 14 0 28 43 Natural Sciences & Mathematics 0 8 0 9 17 Social Sciences 5 12 0 7 24 Total 23 79 2 82 186

Source: Universities in Porto

37 Portuguese Offer To The European Medicines Agency (EMA) Relocation

4. APPROPRIATE ACCESS TO THE LABOUR MARKET, SOCIAL SECURITYAND MEDICAL CARE FOR BOTH CHILDREN AND THE SPOUSES

Portugal has a wide experience in welcoming international Organisations.At European Union level it has welcomed since 1998 the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA), and since 2004 the European Maritime Safety Agency (EMSA).

Other international organisations have also chosen Portugal to establish themselves, mainly (community of Portuguese speaking countries), North-South Centre of the Council of Europe's and some of NATO’s structures.

Portugal is internationally recognised as a friendly country that welcomes not only those who visit but also those who intend to move here.

According to the Global Peace Index, elaborated by the Institute For Economics and Peace, Portugal

38 Portuguese Offer To The European Medicines Agency (EMA) Relocation

is the third most peaceful country in the world and the first within the European Union. 4. APPROPRIATE ACCESS TO THE LABOUR MARKET, SOCIAL SECURITYAND MEDICAL CARE FOR BOTH CHILDREN AND THE 4.1. THE WELCOME ONE-STOP-SHOP SPOUSES

In order to help the settling in and integration of the employees, Portugal will create a Welcome One- Portugal has a wide experience in welcoming international Organisations.At European Union Stop-Shop, whose main purpose will be to help EMA staff and their families throughout the moving level it has welcomed since 1998 the European Monitoring Centre for Drugs and Drug Addiction process, making procedures easy, and minimising the impact of this relocation. (EMCDDA), and since 2004 the European Maritime Safety Agency (EMSA). The aim of the Welcome One-Stop-Shop is to:

• Make sure the move is swift and smooth for all families, by bringing into play services and Other international organisations have also chosen Portugal to establish themselves, mainly consultancy. (community of Portuguese speaking countries), North-South Centre of the Council of Europe's and some of NATO’s structures. • Communicate clearly the interaction needs with the Portuguese public administration entities in order to ease and/or mediate the relationship with those entities;

• Provide information regarding the rights and obligations of the foreign citizens in Portuguese Portugal is internationally recognised as a friendly country that welcomes not only those who visit but territory; also those who intend to move here. • Make sure the customer service is effective, in an integrated and streamlined way, minimising unnecessary bureaucratic interactions. This One-Stop-Shop will render advice on several important areas and services to help in the moving and settlement of EMA staff and their According to the Global Peace Index, elaborated by the Institute For Economics and Peace, Portugal families, encompassing not only on the so called public services (including a contact point with

39 Portuguese Offer To The European Medicines Agency (EMA) Relocation

many Ministries), but also the private associations (such as the private schools association).

In particular, it will be possible to obtain information and consultancy at the One-Stop- Shop on the following subjects:

• Welcome to the country and the necessary formality management;

• Establishment of a residence and settling in;

• Following the transistion to the Portuguese schooling system (see 3.2);

• Information on the transportation network;

• A health “concierge” service;

• A service for the swift integration of spouses in the Portuguese labour market

This One-Stop-Shop shall initially be established on location in London, in the months preceding the Agency's relocation and, later, also in Porto in order to accompany the entire transition. It will remain available in Porto, in the 18 months following the relocation, in order to guarantee an adequate follow-up. Additionally, it will be complemented with an online version - “Digital One-Stop-Shop” -which will become available simultaneously with the physical structure in London.

Efforts to ease citizens lives, such as this proposal for EMA staff and their families, is a structural policy of the Portuguese Government in the last years, with several programmes developed. The most iconic is Programa SIMPLEX, launched in 2006. This programme gathers several initiatives and its main goal is to ease the lives of the citizens and enhance the business environment in their relations with the Administration while simultaneously contributing to a raise in internal efficiency of public services. Its main operating tools are based on legislative and administrative simplification and on measures to implement digital reform.

This strong commitment to the simplification and digital reform of public services, allowed Portugal to reach top positions at European level in the indicators of eGovernance. As referred in the recent report from the European Commission (“European e-Government Benchmark”), Portugal ranks 4th regarding citizen-oriented services, 4th in transparency, and 6th place as facilitators of information technology. In the mobility across borders indicator, Portugal also ranks above European average, regarding companies, and in line with the average, regarding citizens.

The existence of a unique service in Porto - a "health concierge", is also worth highlighting. It is a personal assistant who will support EMA staff and their families, refer them to renowned doctors at national and international level, and recommend the best hospitals and treatments for each specific case.

A free-of-charge international phone line will also be made available to EMA staff, in order to provide tailor-made assistance and specific information in real time about the city of Porto.

40 Portuguese Offer To The European Medicines Agency (EMA) Relocation

4.2. WELCOME PACKAGE

4.2.1. TAXATION REGIME

Portugal offers one of the most attractive taxation regimes worldwide, for qualified professionals in high added value activities. Aiming to attract these professionals to Portugal, in 2009 the non-habitual resident regime was created.

In order to comply with this regime, both foreigners and Portuguese citizens should establish their tax residence in Portugal for a period of over 6 months of the fiscal year or keep a residence for housing purposes in Portuguese territory. In addition, they cannot have been considered residents in Portugal in the 5 years previous to the demand, the same being applicable during a period of 10 years from the date of registration as tax resident in Portugal.

This particular regime is limited to candidates whose line of work falls into the definition of high value added (as defined by law), including, with no limits, investors, managers, directors, medical doctors, artists, architects, and so on. According to this regime, the income earned through these activities developed in Portugal is subject to a personal income tax flat-rate of 20%. Provided that additional criteria are met, income earned in other countries by these professionals can also be taxed at the same level.

The Portuguese Government believes that the possibility of benefiting from this taxation regime constitutes a pull factor for the spouses of EMA staff, in the establishment of their professions and activities in Portugal. This attractiveness factor works not only for the spouses of EMA’s present staff, but also for the potential employees from all over the European Union who might be recruted in the future.

41 Portuguese Offer To The European Medicines Agency (EMA) Relocation

4.2.2. JOB SEARCH ASSISTANCE

The Portuguese economy has a very positive perspective of future growth.1 In the first three months of this year, the GDP registered the highest growth since the beginning of the century (2.8%) which should lead to a growth higher than 2% for the whole year, above the European average, while the 2016 deficit (2%) was the lowest of the last 40 years.

Since 2016, 135 thousand new jobs were created and employment is growing across all sectors, especially in the more productive ones. The unemployment rate shrank to pre-crisis levels and is currently at 9,4% in a context of active population growth.

The sustained recovery of the Portuguese economy together with the increasingly positive image of the country abroad is boosting the confidence of the economic agents. The consumer confidence is at its highest level ever and the economic climate reached its highest reading of the last 15 years, pointing to a long-term growth of the economy.

The high number of initiatives to promote entrepreneurship, which have attracted talent and international innovation to Portugal, demonstrates the Portuguese Government's commitment in this recovery. Nowadays, Portugal ranks 25th in the world when it comes to offering the best conditions to create a new business (World Bank ranking).

The spouses of EMA staff will have all these tools at their disposal to help create their own businesses, as well as the State’s support if they are looking for dependent employment opportunities.

The Institute of Employment and Professional Training (IEFP) can supports any resident citizen in the search for an employment, by means of the on-line portal, or in person, at a public employment office. Additionally, through the EURES network,2 the IEFP can provide support in hiring qualified professionals in Europe.

According to the profile of each spouse, the IEFP, in close cooperation with the Welcome One-Stop -Shop, will help select the most adequate tools for the swiftest integration in the Portuguese labour market.

1 For more detailed information on the Portuguese economy and its developing mode , see Annex 1 - Macroeconomic framework 2 www.eures.europa.eu

42 Portuguese Offer To The European Medicines Agency (EMA) Relocation

4.2.3. SOCIAL SECURITY

Portugal has an advanced social protection system intended to ensure the citizens basic rights and equal opportunities, as well as promoting the welfare and the social cohesion for all Portuguese citizens and foreigners that develop a professional activity or reside in the national territory. The social security system is managed by the Ministry of Labour, Solidarity and Social Security at central level, and by the Regional Social Security Centres at local level.

The tax-paid occupational protection system of Social Security has been reshaped according to the changes registered in the labour market, including the mainstreaming of new types of contractual terms, the diversification of labour incomes, as well as the increase of contingency risk that workers are exposed to.

The present setting of the Social Security System assembles the contributions of several three-party agreements devised in the context of the permanent social consultation committee (CPCS).

The contributory regime and applicable protection to the EMA’s staff relatives is similar to a Portuguese dependent or independent employee, with the same rights and obligations.

In the case of nationals of the other Member-States of the European Union, these citizens will be covered by the Regulation Coordinating Social Security Systems that states they can choose where to pay their contributions,either by the country of origin of the working contracts, or their country of residence (in this case Portugal). In the case of independent workers, if they start their activity in Portugal, they are obliged to contribute to the Portuguese social security system.

Whatever your contributing option, all contributions will be added to the previously made in the country of origin for warranty payment contributing effects, under the multilateral convention for social security in the European space. This way, contributions such as illness support or parental leave will not be affected by the vesting country change. Likewise, the contributing time in Portugal will be accounted for the insurance history, the right assisting, by the time of the retirement, to a pension granted by the Portuguese system.

Additionally, and for non-covered citizens by any mandatory system of social security of any country, there is also the possibility of contributing for the Portuguese Social Security through voluntary payments, as long as they have been residing in Portugal, at least for more than one year.

43 Portuguese Offer To The European Medicines Agency (EMA) Relocation

4.2.4. HEALTH CARE ACCESS

Portugal has a long tradition in health care system provided by the state. The first legislative initiatives for this purpose having been taken in 1946. Following the democratic revolution in 1974, a restructuring of these services took place leading to the creation of the present national health service (SNS) in 1979. The SNS is a universal access service, funded by the Portuguese State central budget, its main objective being the defence of the citizens’ individual and collective health. In parallel to the SNS, there are insurance systems specific to some professions (for example public servants or bank employees), the so called subsystems, as well as the private health insurances with voluntary contribution.

The Portuguese national health system which includes the three above mentioned components (SNS, subsystems, and private insurances), stands out for its quality and international acknowledgement, having reached the 12th position (in 191 countries) in the 2016 World Health Report by the World Health Organization. Other indicators at European level, such as the Euro health Consumer Index 2016, confirm the good performance of the Portuguese health system, with a 14th place (among 35 countries). The high number of medical doctors per inhabitant, about 443 per 100,000 inhabitants (in 2014), is crucial to guarantying this system’s quality, Portugal being the 5th country in the 28EU in this indicator, above the European average of 350 medical doctors per 100,000 inhabitants.

All citizens have access to the health care rendered by the SNS, including foreign citizens, the last being given a user card that grants them equal rights to any Portuguese citizen. Regarding the relocated EMA staff and their families in Porto, a direct registration will be provided so that they can have a national health system user number to access the services of public health centres immediately.

The preferential “gateway” to the SNS is the primary health care network, consolidated by the network of family health care units (USF), personalized health care assistance units (USCP) assembled in the health centres groupings (ACES). This organisation resulted from the primary health care reform that started in 2005, aiming to improve the accessibility, quality, continuity, and efficiency of the health care, as well as the users and the professional’s satisfaction. This network is composed of almost 500 USF and more than 400 UCSP, organised in 55 ACES throughout the country. The citizens (Portuguese and foreign with residence permit) should be enrolled in the USF, or UCSP of their residence area, where a general practise doctor (“médico de família” family doctor) is assigned to them, who will render the primary medical care including prevention. In case of acute disease, the family doctor should direct the patients as to the specialised health care, available in the network of nearly 120 public hospitals.

The private health care offer has registered an enormous growth in the latest years, with a huge variety of hospitals and private clinics spread throughout the country. Presently, the private operators offer more than 140 units with in-patient treatment capacity throughout the country, including about 90 hospitals. Many of these operators have been working for a long time with the main international insurance companies, and have a vast experience in the assistance of non-Portuguese patients.

44 Portuguese Offer To The European Medicines Agency (EMA) Relocation

There are 1285 healthcare units in Porto and 4349 in the Porto Metropolitan Area. When it comes to healthcare units with hospitalization services, 21 are located in Porto and 65 in the Porto Metropolitan Area.3

4.2.5. PORTUGUESE LANGUAGE TEACHING

Portuguese is the official language in several countries, with a speaking populations exceeding in the whole, 260 millions of people. It is a global language projecting itself all over the world. It is among the five most spoken languages, as well as being among the five most used by the Internet users. It is the third most spoken Indo-European language, after Spanish, and English, and the first more spoken in all southern hemisphere. It is an official language in European countries, Latin America, West Africa, Southern Africa and Southeast Asia and, by way of the diaspora, it is also systematically used in north America, south Asia, and in the Oceania.

The Instituto Camões — institute of the language cooperation4– provides free, in a self-taught apprenticeship, on-line courses of Portuguese, assisted by an e-learning platform and an application. These courses are promptly made available to the EMA’s employees and their families. In addition, the Instituto Camões also offers tutorial courses, in-person and specialised for an affordable price.

3 Source: ERS 2017 4 http://www.instituto-camoes.pt

45 Portuguese Offer To The European Medicines Agency (EMA) Relocation

5. BUSINESS CONTINUITY

Portugal is committed to a smooth relocation of EMA into the new headquarters, making sure the Agency can start its business in the new location, by the time the United Kingdom leaves the European Union, thus guaranteeing the business continuity of the Agency, which should remain operational during the transition.

As it can be verified in the previous chapters, in order to assure this transition, Portugal is committed to comply with the necessary timeframe, namely in what refers to: (i) the availability of adequate premises for the Agency’s headquarters; (ii) the availability of appropriate education for the children of Agency staff; (iii) the interface that will allow the staff and their families to successfully settle in, having access to all the information needed to contact with the relevant services.

For that purpose, it must be mentioned that INFARMED, I.P., which plays an important role in the European medicines regulatory system and within EMA, is committed to reinforce its collaboration with the Agency.

46 Portuguese Offer To The European Medicines Agency (EMA) Relocation

The socio-economic conditions offered by Portugal and by the city of Porto assures that EMA will 5. BUSINESS CONTINUITY have a highly attractive location for the qualified human resources it needs in order to maintain the demanding working standards in the medicines sector. In Portugal, and in Porto, the dynamic of growth, recognition and competitiveness of the healthcare sector and, in particular, the quality and availability of its human resources, is as privileged source to attract the necessary human resources Portugal is committed to a smooth relocation of EMA into the new headquarters, making sure for a smooth transition to Portugal. the Agency can start its business in the new location, by the time the United Kingdom leaves the European Union, thus guaranteeing the business continuity of the Agency, which should remain operational during the transition. Portugal’s commitment to the business continuity of EMA will be translated into a headquarters agreement to be signed after the decision of the Council of the European Union on its relocation As it can be verified in the previous chapters, in order to assure this transition, Portugal is committed to comply with the necessary timeframe, namely in what refers to: (i) the availability of adequate premises for the Agency’s headquarters; (ii) the availability of appropriate education for the children 5.1. INFARMED COOPERATION WITH EMA of Agency staff; (iii) the interface that will allow the staff and their families to successfully settle in, having access to all the information needed to contact with the relevant services.

INFARMED, I.P., National Authority of Medicines and Health Products, is the national authority responsible for the regulation and supervision of medicines for human use and health products For that purpose, it must be mentioned that INFARMED, I.P., which plays an important role in the (medical devices and cosmetic products). It has a staff of about 350 highly qualified professionals in European medicines regulatory system and within EMA, is committed to reinforce its collaboration several areas, in particular the life sciences. In its activities, INFARMED also counts on the support of with the Agency. expert committees gathering something like 300 people from academic institutions.

47 Portuguese Offer To The European Medicines Agency (EMA) Relocation

Throughout the years, in order to fulfil its mission and vision, INFARMED has developed a set of initiatives to play a fully-fledged role in the European regulation, to upgrade of its means and resources, and to promote efficiency and quality management.

INFARMED contributes, in a decisive way, to: the evolution of the European regulation; the sustainability of the SNS; a greater transparency, access, quality and equality in the sector of medicines and medical devices; the evolution of the evaluation model of health technology; the innovation in the biomedical sciences; and the growing demand of information and health literacy by citizens.

The prestige of INFARMED and its active participation in the scientific evaluation processes of EMA place Portugal as a country that stands out to host the Agency, ensuring as well the stability conditions the whole system needs to work.

Since its accession to the European Union, Portugal has maintained an active role, both in the establishment of the European regulatory system for medicines, and in its development and consolidation.

Another corollary of this intervention is the top position occupied by the Portuguese regulator in the framework of the medicines evaluation procedures and in the coordination of committees and work groups of EMA.

Moreover, Portugal has a prominent position as one of the first coordinators of the current management structure of the heads of medicines agencies network, an indispensable element for the definition of the strategic planning of the European regulatory system for medicines, in which EMA is included.

This close relationship between INFARMED and EMA is also materialised by the dozens of Portuguese employees – admitted trough international application processes – working for the Agency, many of them in top positions.

INFARMED has promoted the reinforcement of the investment in emerging specialising areas, through the investment in the training, in the technical and laboratory capacities and in the research programmes in the medical, pharmaceutical and biomedical engineering areas. With this, INFARMED aims at a significant raise of the competitiveness, the technical-scientific capacity and the adequacy of its services in order to match EMA’s relocation to Portugal.

INFARMED is currently under a process of reviewing its legal status. The goal is to strengthen, affect and mobilise the national technical-scientific skills, in order to ensure a decisive and active participation in the evaluation of medicines, with a particular focus on innovative products, giving the National Authority the necessary human, scientific and technical resources for the task. This change

48 Portuguese Offer To The European Medicines Agency (EMA) Relocation

will lead to a raise in its efficiency in what regards the participation in the European regulatory system under the aegis of EMA and the European Commission.

INFARMED has been reinforcing as well, in number and competences, its Expert Committees in order to cope with the evaluation processes that will be redistributed as a result of the United Kingdom exit from the European Union, thus supporting EMA’s business continuity and complying with the high quality standards that public health protection demands.

This reinforcement of the evaluation capacity is also reflected at organisational level. The planning and allocation process of resources aims to achieve by 2019 the optimisation of the evaluation times and a significant increase in the number of procedures that Portugal will be ready to evaluate. In order to reach these goals the Portuguese Government will invest 4,8 million euros.

INFARMED’s active involvement in the European health system, inevitably associated to its high technical-scientific reputation, can be quantified by the following data:

• Member of EMA’s Committees since 1995;

• 3rd place as a reporter of pharmacovigilance procedures;

• 4th place of Portugal as a Member-State of reference for authorisation procedures by mutual- recognition or decentralised;

• 2nd place in the evaluation of orphan drugs designations;

• Portugal as chair of the orphan drugs Committee;

• Portugal among the 3 countries with the largest number of EMA senior officers;

• Portugal in the 8th place of EMA’s total staff (890);

• Since 2005, more than 125 evaluations under Portugal’s responsibility.

5.2. HIGH ATTRACTIVENESS FOR EMA’S CURRENT STAFF

Besides offering an ecosystem of great dynamism in the health sector, the city of Porto manages to bring together a favourable economic environment, a high quality of life and an affordable life cost: together, these elements will help to guarantee a smooth transition for EMA. In fact, Porto is a highly attractive destination ensuring that the Agency current staff will follow it in the relocation to Portugal.

49 Portuguese Offer To The European Medicines Agency (EMA) Relocation

5.2.1. A DYNAMIC SOCIO-ECONOMIC ENVIRONMENT

Portugal is currently on a sound economic recovery, based on an ambitious plan of structural reforms where modernisation, innovation and qualification of its human resources are key choices. The high levels of security, the political stability, the geography and the excellent climate conditions of Portugal are positive aspects for a favourable business and investment environment.

Portugal constitutes an excellent platform for business expansion: the geo-strategic position of the country, the qualified professionals, the investment-friendly legal and regulatory environment, and the political support of sectors requiring large amounts of know-how and technological input.

The Global Competitiveness Report of the World Economic Forum places Portugal in the 16th position (out of 138 countries) in the global quality of its infrastructures. The road infrastructure quality stands out in this area: the same Report ranks Portugal in the 9th place, with a road network of over 18,000 km and including over 3,000 km of highways.

Portugal has competitive and advanced IT infrastructures that have enabled the growth of an ecosystem of digital development with a dynamic job creation and a surge in new businesses in this area, attracting a growing number of qualified foreign workers.

There is a widespread use of fixed and mobile broadband services, both in state and private sectors. Portugal was ranked 7th, among 61 economies, in what regards digital technologies and communications (IMD- World Competitiveness Yearbook 2016). Also, according to Europe’s Digital Progress Report, 2017, Portugal’s performance in Digital Public Services “remains well above the EU average”, with new public and private initiatives aimed at boosting efficiency and upgrading services to citizens: electronic medical prescriptions are just an example. The quality of communication infrastructures is paramount to achieve these results. According to DESI 2017 – Digital Economy and Society Index –, Portugal ranks 8th in broadband availability, 6th in 4G coverage and 4th in fast broadband subscriptions.

Portugal has become a top destination for foreign investment in recent years. According to EY (EY’s Attractiveness Survey – 2017), the number of foreign investment projects in Portugal grew around 26% in 2016 and 32% of the inquired investors expect to expand or establish operations in Portugal in 2017. The country’s outlook for investment is even brighter with an increase of 15% from 2016 onwards.

Porto is an example of this positive economic trend which is driven by the growth of technology- based industries. On what concerns innovation and entrepreneurship, the city is home to 69 R&D centres which employ 10,245 people. Porto was considered the 3rd best city to invest in Southern Europe (FDI Intelligence, 2014/2015).

50 Portuguese Offer To The European Medicines Agency (EMA) Relocation

Table 5 (a) Key economic indicators – Porto Metropolitan Area

Indicators Porto Metropolitan Area Population (2015) 1,7 million GDP (2015) 28,3 billion € GDP annual growth (2015) 4,1% GDP per capita (2015) 16,374 € GDP annual growth per capita (2015) 4,6% Exports of goods (2016) 10,4 billion € Exports of goods annual growth (2016) 5,4%

Source: Municipality of Porto

During recent years, Porto has also seen a big boom in foreign investment. There are currently 872 foreign multinational companies in Porto Metropolitan Area, 301 of which are located in Porto and.

InvestPorto was created in 2015 by Porto Municipality to support the attraction investment and the city’s economic development. Over the past couple of years, InvestPorto has supported 154 investment projects in the city, 75 of which are international. This represents more than 400 million euros of investment and over 11,000 jobs. Many of these investments are in Information and Communication Technologies, Nearshore and Shared Services, Agrifood, Real Estate, Tourism, Health, Biotech, among others.

An increasingly number of foreign business have chosen Porto to set up their international operations. The first quarter of 2017 has reached unprecedented levels of investment in technological and industrial sectors in the city. Preliminary data show that the growth of companies in the city in the last three years has skyrocketed in 2017. During the past two months many important investments were made and which created highly-qualified jobs.

In the last decade, Porto has seen a remarkable development in its entrepreneurial ecosystem. In 2015, 1,722 new companies were established in the city. This means a growth rate of 30% comparing with 2012. Porto is the Portuguese leading region On what concerns entrepreneurship, accounting for 36% of the startups created in the country.

At present, there are 13 business incubators and 16 co-working spaces in the Porto Metropolitan Area. The Science & Technology Park of the University of Porto (UPTEC) is an award winner of the European Regiostars 2013 and is home to almost 200 of the most innovative startups in Portugal, including those supported by the European Space Agency.

The flourishing entrepreneurial ecosystem, alongside initiatives such as the Web Summit, will contribute to growing new business opportunities, fostering a qualified and innovative labour market.

51 Portuguese Offer To The European Medicines Agency (EMA) Relocation

5.2.2. EXCEPTIONAL QUALITY OF LIFE

In an international context of constant social change and global security challenges, it is imperative to underline Portugal’s unique characteristics in terms of quality of life, which make the country highly attractive for the establishment of a family or individual life plan. As a matter of fact, the country stands out for its environment of peace and security, for the attributes in the field of health and the environment, for the natural qualities, the tourist, cultural and leisure offer, as well as the famous hospitality. Together, these factors make Portugal attractive both for residents and foreign tourists: it is a 10-million inhabitants country that welcomes over 17 million tourists annually.

Portugal is considered the 3rd most secure country in the world (2017), according to the Institute for Economics and Peace. The feeling of security is lived and experienced by the Portuguese in their daily lives as well as by the thousands of tourists that visit the country every year. According to OECD, 69% of the Portuguese think it is safe to walk alone down the streets by night (slightly above the 68% OECD average).

The historical roots of openness to the world go back to the age of Portuguese Discoveries, over five centuries ago. They persist in the Portuguese culture making the country open to outer world. Portuguese people are experts in the art of welcoming and more than 60% speak at least one foreign language, thus making people of other nationalities feel at home.

These characteristics have enabled the country to receive and retain worldwide talent, as shown by the recent Global Talent Competitiveness Index (Insead, Adecco Group, Human Capital Leadership Institute, 2017) that places Portugal in the 31st place among 118 countries. This report underscores Portugal’s position in topics such as tolerance – 5th in tolerance towards minorities and 8th in tolerance towards immigrants – and “lifestyle” – 9th place regarding the combination of indicators that include environmental performance, personal safety, health care and sanitation.

Additionally, Portugal is one of the European countries with the highest availability of solar exposure: an annual average of 2,200 to 3,000 hours of sunlight. In Porto, there are 220 sunny days per year, and a daily average of 7,7 hours of sunlight. Besides the positive effect in the active lifestyle of the population, allows the devising of plans to reduce energy costs, a situation that can be further improved with the adoption of environment friendly energy systems.

Culture is part of Porto’s life. European Capital of Culture in 2001, the city has strengthen its position as a European cultural hub since, attracting visitors from all over the world. In fact, in 2014 and 2017 Porto was a winner of the Best European Destination Awards.

Home to Pritzker prize winning architects, Álvaro Siza Vieira e Eduardo Souto Moura, Porto displays several cultural spaces of excellence (39 museums, 20 cinemas, 12 theatres, 9 showrooms and numerous art galleries), which offer a busy cultural agenda throughout the year.

52 Portuguese Offer To The European Medicines Agency (EMA) Relocation

Among the most renowned Porto’s cultural spaces we find:

• The Serralves Museum of Contemporary Art, visited by over 500,000 people per year, making it one of the most visited Portuguese museums. Designed by Siza Vieira, it is a cultural centre of reference in the Iberian Peninsula.

• Casa da Música, city’s concert hall, is today a major ex-libris of Porto and it is known for its impressive architectural design of the Dutch architect, Rem Koolhaas.

• Teatro Nacional São João is the main theatre in the city and one of the most important in the country. It is listed as a national monument and displays a vast cultural programming.

Porto also hosts major events such as the Red Bull Air Race and the music festivals NOS Primavera Sound and MEO Marés Vivas. Serralves em Festa is one of city’s biggest cultural events combining music, dance, theatre, performing art and contemporary circus by artists from all over the world. It should also be mentioned Porto’s rich tradition of popular festivities: Festa de São João do Porto (Festival of St. John of Porto) is a major event with over six centuries of history that attracts thousands of visitors.

Porto’s cultural offer is complemented by its renowned local gastronomy mixing Mediterranean and Atlantic traditions. The wine region Douro valley – alongside de historical centre of Porto – is recognised as UNESCO World Heritage site.

The city has a vibrant nightlife as well, thanks to the countless cafés and bars that keep Downtown streets alive all night long.

5.2.3. AFFORDABLE COST OF LIVING

Porto combines favourable economic conditions, an exceptional quality of life and an attractive cost of living.

With highly competitive prices in the real-estate sector: the average price of residential leases remained in the €6,50 per sqm in 2016.

53 Portuguese Offer To The European Medicines Agency (EMA) Relocation

Table 5 (b) Average annual expenditures per COICOP category (2015/2016) and average bank valuation price of housing (2016) Socioeconomic indicators Northern Portugal

(€/year) 20,437

Average annual expenditure per household 20,437

Food and non-alcoholic beverages 3,065

Housing, water, electricity, gas and other fuels 6,144

Health 1,127

Transport 3,029

Source: Ministry of Economy, Statistics Portugal (INE)

On what concerns the real-estate market, it is worthy of mentioning that: the average price for residential leases is €6,50 per sqm (data for 2016); while the average price for the acquisition of residence is 1,317€ per sqm (data for 2015). The acquisition of residence is even more accessible in Porto Metropolitan Area: 971€ per sqm. Such values place Porto as highly attractive city at European level.

Graphic 5 (a) Average size (sqm) of new dwelling for EUR 200,000, 2015

Source: Deloitte, Property Index | July 2016; Note: *offering price, **old dwellings ***all the dwellings (old and new), †2014, ††white box condition.

54 Portuguese Offer To The European Medicines Agency (EMA) Relocation

5.3. PORTUGAL AND PORTO: A POOL OF TALENTS IN RESEARCH AND HEALTH SCIENCES

5.3.1. THE SCIENTIFIC AND EDUCATIONAL DIMENSION

According to the Global Competitiveness Index 2016-17 of the World Economic Forum, Portugal ranks in the 25th place regarding the quality of its institutes of scientific research.

The I&D ecosystem in Portugal is composed of public and private sectors. For example, in 2015, the business sector was responsible for the execution of 46% of the total expenditure in I&D and hosted 11,785 researchers.The Portuguese higher education was responsible for an equal percentage, although gathering 25,045 researchers.

The Portuguese scientific community is productive, but also internationally renowned. For example, during the last 10 years, the number of published and quoted articles of Portuguese researchers was multiplied by 4. Half of these publications include authors affiliated with international institutions.

This link to international scientific research has been clearly leveraged due to several partnerships and consortium established between universities and Portuguese institutes of research with international top institutions, such as the Massachusetts Institute of Technology (MIT) or the Carnegie Mellon University (CMU), in different strategic areas that allowed the reinforcement of Portugal’s competitiveness in the economy of global knowledge.

In the health sector in particular, the investment in I&D increased around 128% during the last 10 years and the number of scientific publications by Portuguese researchers (including co-publications with international institutions) has keep up with this trend with an increase of 123% in the same period.

Portugal thus hosts a vibrant and innovative I&D ecosystem, supported by several institutions scientific and technologic-oriented, present throughout the whole chain of value of the health and medicines sector, including the clinical trials. This ecosystem has its roots in a higher education system of renowned quality.

In the specific case of Porto, the city alone hosts seven I&D centres of life sciences, gathering a total of 1,766 researchers, in a symbiosis between universities and hospitals.

55 Portuguese Offer To The European Medicines Agency (EMA) Relocation

Tabela 5 (c) Life sciences research centres in Porto

Research Centre Institution Research Area

Cardiovascular Research and University of Porto (UP) Clinical Research Development Unit Centre for Research in Physical Faculty of Sports, University of Porto Diagnosis, Therapeutics and Public Activity, Health and Leisure (FADE/UP) Health Research Centre of the Portuguese Portuguese Institute of Oncology of Diagnosis, Therapeutics and Public Institute of Oncology of Porto Porto (IPO Porto) Health Centre for Research in Health Faculty of Medicine, University of Porto Clinical Research Technologies and Services (FM/UP) Institute for Research and Innovation in University of Porto (UP) Biomedicine Health (i3S) Centre for Pharmacological Research Abel Salazar Institute of Biomedical Biomedicine and Drug Innovation Sciences Research Unit in Epidemiology - Public Public health institute, University of Diagnosis, Therapeutics and Public Health Institute of the University of Porto (ISPUP/UP) Health Porto

Source: Science and Technology Foundation, Portugal

There are 3,877 researchers in health and medical sciences in Northern Portugal, accounting for around 30% of the country's total. The total number of researchers in health and medical sciences in Porto’s area of influence is 6,407.

In line with the Portugal's strategic focus on innovation and knowledge, the country, as a whole, displays many other research centres of excellence in the areas of the life sciences such as: Research Institute for Medicines (Faculty of Pharmacy, University of Lisbon); Champalimaud Neuroscience Programme (D. Anna de Sommer Champalimaud and Dr. Carlos Montez Champalimaud Foundation); iMM (Institute of Molecular Medicine); GHTM – Global Health and Tropical Medicine (Portuguese Institute of Hygiene and Tropical Medicine); Public Health Research Center (National School of Public Health); Institute for Biomedicine (University of Aveiro); Centre for Biomedical Research (University of Algarve); or the Health Sciences Research Centre (University of Beira Interior).

The Northern Region of Portugal excels in the quality of its higher education institutions. Schools such as the Faculties of Medicine and Pharmacy of the University of Porto and the Faculty of Medicine of the University of Minho ensure the availability of world-class talent. Over 11,000 people graduate each year from health-related university courses in Porto’s area of influence. Over 500 of these graduates are PhD holders.

56 Portuguese Offer To The European Medicines Agency (EMA) Relocation

Tabela 5 (d) Health-related Graduates in Porto’s Area of Influence5a

Bachelor Postgraduate Master PhD Otherc Total Medicine 145 58 1,094 102 0 1,399 Pharmaceutical 355 2 588 45 0 990 Sciences Biology & 35 0 128 37 0 200 Biochemistry Life Sciences 12 0 18 1 0 31 Dental Sciences 173 27 391 6 0 597 Veterinary Sciences 211 0 158 21 100 490 Chemical Process Technologies 515 0 598 87 56 1,256 (incl. biomedical engineering) Psychology 594 0 923 78 12 1,607 Nursing 1,510 297 500 32 70 2,409 Diagnostic and Therapeutic 437 0 118 0 30 585 Technologies Therapy and 771 0 196 8 0 975 Rehabilitation Health Informatics 19 0 35 0 20 74 Other Health-Related 691 53 228 127 0 1,099 Areasb Total 5,468 437 4,975 544 288 11,712

Source: Directorate-General for Statistics of Education and Science (2017)

Porto has an innovative health research, development and innovation (I&D+i) ecosystem, characterized by the presence of world-class institutions and scientists. There are 57 public and private institutions of R&D in health sciences in Porto Metropolitan Area and 117 in the Porto Area of Influence.

The University of Porto is the largest scientific producer in Portugal in health and biomedical sciences, according to 2017 CWTS Leiden Ranking.6

5 a) The area of influence of Porto includes the North-region and a part of the Centre region (includes the districts of Aveiro, Coimbra and Viseu). b) "Other Health-Related areas" includes Health and Safety at work, Public Health, Health related Food Industry, Health related Chemistry, Health in Sports, etc c) "Outros" includes technological specializations courses and others.

6 http://www.leidenranking.com/ranking/2017/list

57 Portuguese Offer To The European Medicines Agency (EMA) Relocation

Graphic 5 (b) CWTS Leiden Ranking 2017 – Publications in biomedical and health sciences in Portugal, 2012-2015 (Web of Science)

Lisboa

Besides, the University of Porto has two leading faculties (Faculty of Medicine and Faculty of Pharmacy) and two university hospitals, C.H. Porto and C.H. São João, which are among the top 3 Portuguese hospitals with the highest R&D expenditure. As a result of its joint programmes with MIT, University of Texas at Austin, Carnegie Mellon University and Harvard Medical School, the university is part of the most prestigious worldwide R&D networks in the fields of biotechnology and healthcare.

The Health Research and Innovation Institute (i3S) of the University of Porto, the largest of its kind in Portugal, with 56 research groups, 800 researchers and an annual budget of 20 million euros, has been winning many international awards, such as the Janssen Innovation Award 2016 and World’s Most Influential Pathologist 2015.

The Faculty of Biotechnology of the Catholic University of Porto hosts the Centre of Biotechnology and Fine Chemistry, a State Associated Laboratory. In collaboration with the private sector, it is investing 50 million euros in the construction of a bioengineering research centre which will become a European Biotech Hub with more than 100 researchers by 2021.

The School of Medicine of the University of Minho hosts the Life and Health Sciences Research Institute (ICVS), which has over 250 researchers producing over 100 publications/year in international top-level scientific journals. Many of them have received national and international awards, such as the L’Oréal for Women in Science Award 2017.

Regarding to clinical trials, three of the five largest players in Portugal are located in Porto – IPO Porto, C.H. Porto and C.H. São João. Moreover, Hospital Prelada, a private hospital in Porto, is building the largest and most modern centre for Phase 1 clinical trials in Europe.

58 Portuguese Offer To The European Medicines Agency (EMA) Relocation

In terms of biomedical engineering, Northern Portugal has the first and only fully international research organisation in Europe in the field of nanoscience and nanotechnology – Iberian Nanotechnology Laboratory (INL). In 2015, it was the organization in Portugal with the highest number of patents filed at the European Patent Office, followed by other entities in Northern Portugal such as the University of Minho, University of Porto, and A4TEC – Association for the Advancement of Tissue Engineering and Cell Based Technologies & Therapies. In addition, the University of Minho is leading a Horizon 2020 project which aims to build the Discoveries Centre for Regenerative and Precision Medicine, one of the largest centres in Europe in human tissue engineering, regenerative medicine, biomaterials and stem cells. The Centre will operate with strong involvement of the University College of London (UCL) and will have some research activities performed in the University of Porto.

The research organizations in Northern Portugal have been actively participating in FP7 and Horizon 2020 projects in health-related areas, with prominent presents in the national total, both in terms of number and value.

Table 5 (e) FP7 Health/IMI projects of national research institutes in Portugal

Number Value Northern Portugal 17 5,919,108 € Portugal 53 19,117,735 € Weight of Northern Portugal 32% 31%

Source: GPPQ/FCT (2017)

Table 5 (f) H2020/ERC Health/Life Sciences projects in Portugal

Number Value Northern Portugal 24 87,108,300 € Portugal 73 183,610,667 € Weight of Northern Portugal 33% 47%

Source: GPPQ/FCT (2017)

The Polytechnic Institute of Porto is carrying out a H2020 teaming project – Nortexcel 2020 – which aims at creating a research and innovation centre in Northern Portugal dedicated to the development of medical devices, support technologies and well-being solutions.

59 Portuguese Offer To The European Medicines Agency (EMA) Relocation

Regarding research infrastructures, five of the nine national research infrastructures of strategic relevance in biological and medical sciences are either coordinated or participated by organizations located in Porto or Northern Portugal:

• TRIS-HCP: Translational and Clinical Research Infrastructures Specialisation Platform – Health Cluster Portugal. The cluster members include prestigious research organisations such as Gulbenkian Institute for Science, i3S, Biocant Park, Champalimaud Foundation, plus more than 100 Portuguese health and pharmaceutical companies, hospitals and academic institutions;

• RNEM: Portuguese Mass Spectrometry Network;

• Genome Portugal: National Facility for Genome Sequencing and Analysis;

• PPBI: Portuguese Platform of BioImaging;

• TERM RES-Hub: Tissue Engineering and Regenerative Medicine

In the areas of life sciences, Portugal offers internationally acclaimed human resources and institutions. But this is part of a wider trend with the country showing a growing qualification of the population, thus increasing the quality of its human resources in the different areas of knowledge. This positive dynamic is exemplified by the fact that, in 2015, the Portuguese students registered a significant performance above the OECD average in two of the three areas assessed by the PISA (Programme for International Student Assessment).

In 2015/2016 Portugal had 356,399 students enrolled in the different levels of higher education. Also in 2015, 89,476 students concluded a degree of higher education. Of those, 27,835 are related to the areas of social sciences, business and law: although not part of EMA’s core business, they are essential to the composition of any large organisation. It is worth mentioning as well the 16,438 graduates, in 2015, in the areas of engineering, processing industries and construction: Portugal ranks at 9th in the availability of engineers (IMD – World Competitiveness Centre).

In Portugal, the education and training are oriented to an increasingly globalised world, which justifies a strong focus on foreign languages. According to the EY –Business Service Centres in Portugal, business refer the facility in finding linguistic skills in English, Spanish, French and, in a smaller scale, German. Regarding specifically English, it should be pointed out that Portugal ranks 12th in English Proficiency Index 2016.

These are some of the cases that demonstrate the capacity and the quality of the Portuguese education and research systems, in Northern Portugal and Porto. They are, in turn, strongly linked to the economic activities in the health sector.

60 Portuguese Offer To The European Medicines Agency (EMA) Relocation

5.3.2. THE ECONOMIC DIMENSION

As mentioned before, several research institutes throughout the country, together with health authorities, universities, hospitals and pharmaceutical industry, form the Health Cluster Portugal, a platform located in the region of Porto, that intends to turn Portugal into a competitive player in the research, devising, developing, manufacturing and commercialization of products and services of high added value related to health, and able to compete in a framework of excellence of the international markets.

The Portuguese Health industry is rooted in a dynamic of innovation and research. The Health Cluster Portugal states:

“The Portuguese pharmaceutical and medical device industries have grown above the country’s average in recent years, with a marked rise in the exports to countries such as the USA, Germany, UK, Angola, Spain, and France. In 2014, the value of Portuguese exports of goods from the health sector was EUR 1,216 million, representing a growth of 94% comparatively to 2008. This value includes the export of basic pharmaceutical products (104 million), pharmaceutical preparations (840 million), irradiation, electromedical and electrotherapeutic equipment (12 million), and medical and dental instruments and supplies (260 million), not including sales of e-health solutions and services.”

The sectors’ exports already surpass those of the more “traditional” ones, such as wine and cork.

There are 4,904 business in life sciences in Porto alone, 17,992 in Porto Metropolitan Area and over 47,000 (manufacturers and service providers in all health-related fields) in Porto area of influence.

61 Portuguese Offer To The European Medicines Agency (EMA) Relocation

Table 5 (g) Number of health-related companies in Porto Area of Influence (2015)

Pharmaceutical Human health and social Veterinary services Total manufacturing support services Porto Metropolitan Area 11 284 17,456 17,751 Northern Portugal 21 577 29,487 30,085 Central Portugal 18 494 17,119 17,631 Total Porto Area of 39 1,071 46,606 47,716 Influence

Source: Statistics Portugal (INE) (2017)

This high level of industrial activity is reflected by the large number of skilled professionals in related areas, as demonstrated by the table below.

Table 5 (h) Number of relevant industry professionals in the Porto area of influence (2015)

Veterinary service Pharma and human Law and finance Doctors Pharmacists personnel health support related personnel

Northern Portugal 3,542 1,279 52,752 38,758 19,940

Central Portugal 2,644 955 30,291 22,886 11,309

Porto Catchment Area 6,186 2,234 83,043 61,644 31,249

Source: Statistics Portugal (INE), Pordata (2017

62 Portuguese Offer To The European Medicines Agency (EMA) Relocation

5.4. BENEFITS TO BE GRANTED TO THE AGENCY

In case of EMA’s relocation to Porto, Portugal will sign a headquarters agreement with the Agency, in line with the Commission guidelines with standard provisions for headquarters agreements of EU decentralised agencies and the legal instruments signed with the agencies already located in the country, covering all the offered benefits in this candidature, especially on what concerns the conditions for the Agency’s use of the new premises and the One-Stop-Shop.

The legal instrument to be signed will establish that, in addition to the privileges and immunities defined in Protocol nr. 7 of the Treaties, the staff of the Agency will enjoy the privileges and immunities, exemptions and facilities granted to members of a comparable category of the diplomatic corps in the Portugal.

Portuguese authorities also commit to take all necessary measures to facilitate the entry into Portuguese territory, stay and departure of experts on mission to the Agency, as well as all persons invited by the Agency to participate in its activities. Visas and any other authorisations shall be issued to them free of charge and as speedily as possible, as well as assistance in transit, if necessary.

63 Portuguese Offer To The European Medicines Agency (EMA) Relocation

6. GEOGRAPHICAL SPREAD

The purpose of the geographical spread established in December 2003, by the representatives of the Member-States, meeting at Head of State or Government level, and confirmed in 2008, although desirable, cannot be a decisive criterion in EMA’s process, since it is a case of relocation of an already existing agency and not the creation of a new one.

On the other hand, although the decision to be taken in November by Member-States is one of political nature, there is necessarily a technical part to be considered. The specificity of the medicines sector, with all its impact on the public health, demands that this dimension is duly weighed, in order to guarantee an efficient and effective transition, thus minimising the impact on the Agency’s business continuity.

Moreover, in Portugal, EMA will benefit from greater synergies and cooperation with the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA), based in Lisbon. Within the framework of the European agencies, the EMCDDA is one of EMA’s main partners, working together in areas such as information exchange, risk assessment and control of new synthetic drugs. The ad hoc cooperation (information exchange) between the EMCDDA and EMA started in 1995 when the two agencies became fully operational. However it was only after the launch of the 1997 EU Joint action concerning the information exchange, risk assessment and the control of new synthetic drugs that

64 Portuguese Offer To The European Medicines Agency (EMA) Relocation

the partnership between the two agencies went beyond information exchange to become a fully 6. GEOGRAPHICAL SPREAD fledged cooperation. The close collaboration between the two agencies is reflected in the working arrangements signed in 2010 and 2012.

The purpose of the geographical spread established in December 2003, by the representatives of the Member-States, meeting at Head of State or Government level, and confirmed in 2008, although Finally, it must also be mentioned that with the relocation of EMA’s headquarters to Porto, Portugal desirable, cannot be a decisive criterion in EMA’s process, since it is a case of relocation of an already will be implementing a policy of geographical spread of European organisms within the country, thus existing agency and not the creation of a new one. promoting cohesion and territorial enhancement and further connecting citizens with the European project.

On the other hand, although the decision to be taken in November by Member-States is one of political nature, there is necessarily a technical part to be considered. The specificity of the medicines sector, with all its impact on the public health, demands that this dimension is duly weighed, in order to guarantee an efficient and effective transition, thus minimising the impact on the Agency’s business continuity.

Moreover, in Portugal, EMA will benefit from greater synergies and cooperation with the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA), based in Lisbon. Within the framework of the European agencies, the EMCDDA is one of EMA’s main partners, working together in areas such as information exchange, risk assessment and control of new synthetic drugs. The ad hoc cooperation (information exchange) between the EMCDDA and EMA started in 1995 when the two agencies became fully operational. However it was only after the launch of the 1997 EU Joint action concerning the information exchange, risk assessment and the control of new synthetic drugs that

65 Portuguese Offer To The European Medicines Agency (EMA) Relocation

ANNEX I - MACROECONOMIC OUTLOOK

The Portuguese economy is currently registering a stable and solid economic growth and converging with the European Union at a sustainable pace. After a continuous recovery throughout 2016, GDP reported the highest quarterly growth rate since the beginning of the century in the first quarter of 2017 (2,8%). The most recent data points towards the continuity of this solid economic performance in the second quarter of the year, which should lead to an annual rate growth of more than 2% in 2017, above the UE average and exceeding the most recent forecasts from national and international institutions that follow the Portuguese economy.

In 2016, Portugal reported a state budget deficit of 2% of the GDP - the lowest reading since 1974 – meeting the budgetary targets required by the European institutions for the first time in the last 10 years. This paved the way to the exit of the Excessive Deficit Procedure this year. In the first quarter of 2017, the government budget deficit was 2,1% of GDP (3,3% in 1Q 2016), ensuring a sustainable path to meet the objective of reaching a budget deficit of 1,5% in 2017 as established in the country´s Stability Programme. In the upcoming years, the public accounts are expected to maintain a solid and sustainable trend with the improvement of the budgetary balance, together with a sustained public debt reduction. The rigorous management of the public accounts will reinforce the confidence in the national economy, lowering the country´s financing costs in order to support growth.

The labour market is showing a robust recovery. Since 2016, 135 thousand new jobs were created and employment is growing across all sectors, especially in the more productive ones. The unemployment rate shrank to pre-crisis levels and is currently at 9,4% in a context of active population growth. By adding more qualified employees in the labour market, the labour productivity will rise throughout the next years, thus contributing for the sustainability of the Portuguese economy competitiveness.

The sustained recovery of the Portuguese economy together with the increasingly positive image of the country abroad is boosting the confidence of the economic agents. The consumer confidence is at its highest level ever and the economic climate reached its highest reading of the last 15 years, pointing to a long-term growth of the economy.

The exports are rising in a steady way, representing 43,1% of the GDP, and thus enabling the economy with a more solid structure for the current economic upturn. The increase in exports will also contribute to the structural change of the Portuguese economy. Until 2021, external demand will contribute positively to the growth of the economy, with an increase of 4,5% in exports, which will exceed the 4,1% growth expected for imports.

Portuguese companies are well integrated and consolidated in the EU markets. They´re are diversifying their businesses, both at sectorial and geographic levels, and investing more in innovation, that is leading to successive gains in market share in foreign markets.

66 Portuguese Offer To The European Medicines Agency (EMA) Relocation

Companies in Portugal have increasingly been registering gains of productivity and profitability, with more solid and less leveraged balance sheets thus increasing their capacity of financing. On the other hand, the financial system is stabilising, which contributes in a positive way to a sustainable investment recovery in Portugal.

The investment registered the highest annual growth of the last 18 years in the first quarter of 2017, mainly on key-sectors, such as construction. These developments reflect the acceleration of implementation of the European funds and show a growing confidence of companies in the economy that should continue in the medium term.

Supported by a model based on employment, investment and confidence, the Portuguese economic recovery is built on an ambitious reform agenda, an agenda for the decade that includes several structural reforms where modernisation, innovation and qualification of the human resources are key elements.

This reform roadmap is summed up in the country´s National Reform Programme (NRP), a long-term strategy that promotes economic growth, more jobs, more equality, supporting the transformation of the national productive structure for exports and the creation of better jobs. The implementation of the NRP and Stability Programme will correct domestic economic imbalances by fostering the potential growth, through more investment and more employment, thus promoting social cohesion.

The economic strategy for the medium term is focused on investment in knowledge and innovation, modernisation of businesses and public administration, enhancement of the territory and its resources, eradication of poverty and reduction of inequity.

The financial sector stabilisation, the consolidation of the public accounts and the implementation of the NRP constitute a solid foundation for an inclusive growth that guarantees convergence with Europe.

Key Macroeconomic Indicators ( 2017-2021) (% Change) 2017 2018 2019 2020 2021 GDP 1,8 1,9 2,0 2,1 2,2 Private consumption 1,6 1,6 1,6 1,6 1,6 Public consumption -1,0 -0,8 -0,9 0,0 0,5 Investment (GFCF) 4,8 5,1 5,1 4,8 4,7 Exports of goods and services 4,5 4,5 4,5 4,5 4,5 Imports of goods and services 4,1 4,1 4,1 4,1 4,1 Employment 1,3 1,0 1,0 1,0 1,0 Unemployment rate (%) 9,9 9,3 8,6 8,0 7,4

Source: Portugal: Stability programme 2017-2021

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