PORTUGUESE OFFER TO THE EUROPEAN MEDICINES AGENCY (EMA) RELOCATION - Consilium.europa.eu
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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
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 Heritage Centre and its service centre, yet not far from the best residential areas. Any of the three options is easily accesible by metro, with stations less than three minutes away, thus connecting to the whole city and to main infrastructure such as the airport, universities, hospitals and other equipment in the metropolitan area. Urban and inter-city road and railway network are also within close reach. The three proposed locations are immediately available for EMA’s relocation, since they have planned works already in the design phase. 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 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 Yes Yes Yes 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. 20
Portuguese Offer To The European Medicines Agency (EMA) Relocation 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. 23
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 The city is thus connected to all of Europe. EU Member-State capitals can be reached within an average of 4 hours. 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 31
Portuguese Offer To The European Medicines Agency (EMA) Relocation 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 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 network of the AEFE (Agence pour l’enseignement français à l’étranger), this school provides intensive French language 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 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 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. Colégio Luso-Internacional do Porto (CLIP) 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 35
Portuguese Offer To The European Medicines Agency (EMA) Relocation 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. 4.1. THE WELCOME ONE-STOP-SHOP In order to help the settling in and integration of the employees, Portugal will create a Welcome One- Stop-Shop, whose main purpose will be to help EMA staff and their families throughout the moving process, making procedures easy, and minimising the impact of this relocation. 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 consultancy. • 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 territory; • 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 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
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