ABPI and BIA – Written Evidence (UER0006)
A1. The UK’s membership of the EU has provided much of the scientific, regulatory and trade infrastructure for the life sciences sector in the UK. The new UK-EU relationship should ensure that the UK life sciences sector remains strong in the interests of public health and safety.
A2. We have welcomed the Prime Minister’s commitment to explore the terms on which the UK could remain part of the European Medicines Agency (EMA) to achieve the best outcome for patients, across the UK and in Europe. Alongside regulatory cooperation, ensuring that the supply of medicines is uninterrupted is essential to ensure patients have access to the medicines they need from day one of the UK leaving the EU.
A3. Every month, 45 million patient packs of medicine move from the UK to the EU, with 37 million patient packs moving from the EU to the UK. (1) Pharmaceutical companies require legal certainty, currently provided by multiple regulatory approvals, in order to manufacture and supply medicines for patients. It is vital that agreement on the close cooperation on medicines regulation is prioritised in the second phase of negotiations.
A4. The ABPI and BIA have welcomed progress on negotiations and the agreement of an implementation period. However, as this is subject to the final agreement, we need rapid clarity on the legal position of medicines during the implementation period from the EU and UK. In addition, we need progress on how the desired close cooperation will work in practice.
A5. Securing regulatory cooperation for medicines in the UK’s new relationship with the EU will send a strong, positive message to global boardrooms. Achieving alignment and agreement in the UK’s new relationship will further support the Government’s ambitions for a strong life sciences sector, as outlined in their Industrial Strategy.
B1. The Association of the British Pharmaceutical Industry (ABPI) represents innovative research-based biopharmaceutical companies, large, medium and small, leading an exciting new era of biosciences in the UK. We represent companies who supply more than 80 per cent of all branded medicines used by the NHS and who are researching and developing the majority of the current medicines pipeline, ensuring that the UK remains at the forefront of helping patients prevent and overcome diseases. Globally our industry is researching and developing more than 7,000 new medicines (2).
B2. The BioIndustry Association (BIA) is the trade association for innovative life sciences organisations in the UK. BIA members include emerging and more established bioscience companies, large pharmaceutical companies, academic research and philanthropic organisations, and service providers to the UK bioscience sector. Our goal is to secure the UK's position as a global hub and as the best location for innovative research and commercialisation, enabling our world-leading research base to deliver healthcare solutions that can truly make a difference to people's lives.
B3. The ABPI and the BIA have worked closely together since the outcome of the referendum on the UK’s membership of the European Union. Our objective is to ensure that the UK life sciences sector is in as strong a position as possible as the UK establishes a new relationship with the EU in the interests of public health and safety.
B4. In July 2016, the ABPI and BIA worked with Government to establish a joint industry and Government forum to discuss the impact of the UK leaving the EU on UK life sciences. The UK EU Life Sciences Steering Group is currently co-chaired by GSK and AstraZeneca, with the Life Sciences industry further represented by the ABPI, BIA and the Association of the British Healthcare Industry (ABHI) (3). Government ministers and civil servants are also members of the Steering Group.
B5. The key objective of the Steering Group is to determine how to create a world-leading Life Sciences environment in the UK outside of the EU, including ensuring a framework for a continued dialogue between the life science industry and the government. Under their direction, we held over 50 hours of working group meetings with over 200 experts in 90 organisations in the summer 2016 to inform our policy analysis (4). The issues identified were as follows:
The themes of which run through this submission.
B6. We welcome the opportunity to submit evidence to the House of Lords Select Committee on the key priorities for the UK’s future relationship with the EU to maintain a thriving life sciences sector and safeguard public health.
C1. Implementation period. We welcome the political agreement of an implementation period, as per the draft Withdrawal Agreement published in March. This period is necessary to accommodate the considerable changes in process, workforce and infrastructure ultimately required in a new UK-EU relationship, to protect public health and patient safety in the UK and EU. It is crucial that this period is confirmed in the final Withdrawal Agreement, as this will provide companies with the necessary legal certainty.
C2. Regulation of medicines. For the mutual benefit of patients and the life sciences sector in the UK and the EU, the UK should seek to negotiate alignment and commonality with the EU for the regulation of medicines, Regulatory cooperation is critical for companies because the regulations are the legal basis on which authorisations are given to manufacture, research and supply medicines. The new relationship should:
C3. Trade and supply. Medicines move across multiple borders during manufacture and research due to the highly specialised technology involved and the integrated nature of existing supply chains. Due to this complexity the UK needs to secure the ability to freely trade and move medicines and pharmaceutical supplies across borders. This should be as frictionless as possible and include:
C4. Access to talent. The UK should seek to negotiate an agreement with the EU that facilitates the ease of movement for highly-skilled talent in Life Sciences, through:
C5. Scientific research and collaboration. The UK should seek to negotiate continued and predictable access to funding and collaboration for scientific research. This should include:
D1. The UK’s membership of the EU has provided much of the scientific, regulatory and trade infrastructure for the pharmaceutical industry in the UK. The negotiations that determine Britain’s new relationship with the European Union will be critical to how medicines are delivered to patients in the UK and in the EU, and the future success of the life sciences sector.
D2. The ABPI and BIA have welcomed progress in negotiations and the agreement to an implementation period (5). The Government should seek continued close cooperation of medicines regulation and achieve frictionless trade of medicines to ensure patients can access the medicines they need from day one of the UK leaving the EU.
Regulation
D3. The ABPI and BIA have warmly welcomed the Prime Minister’s position that “UK and EU regulatory standards will remain substantially similar in the future” and recognition that continued “membership of the European Medicines Agency would mean investment in new innovative medicines [continue] in the UK” (3). This position would be in the best interests of UK and European patients.
D4. The UK brings significant expertise and experience to the authorization of medicines and medicine products across the EU. The UK Medicines and Healthcare products Regulatory Agency (MHR)A was Rapporteur for about 20% of centralised procedures for marketing authorization and performed over 30% of GMP inspections coordinated by the EMA. However, the EMA guidance and position of the EU Council is that the UK would play a limited role in the EMA (6,7). This is concerning for patients in both the UK and EU. In negotiating the future relationship, it will be important to secure the maximum possible role for the UK in the EMA.
D5. Given the potential impact on patients and public health, the ABPI and BIA believe that the UK Government and Commission should approach issues surrounding the regulation and supply of medicines in the interests of public health. In order to deliver further certainty for the bio-pharmaceutical industry, it is critical that the negotiations between the UK Government and the European Commission progress to resolving this.
D6. The regulatory mechanisms for ensuring companies continue to have a legal basis for manufacturing and supplying medicines need to be clarified urgently. Companies are having to make decisions regarding infrastructure and workforce in order to meet the deadline of 29th March 2019. If clarity and legal certainty are not given urgently, decisions will be made that could impact the ability of the UK to benefit from any future relationship in the short to mid-term as companies are unlikely to be willing to make a second set of changes immediately after a first set.
D7. The European regulatory landscape has already started to change. For example, the Heads of Medicines Agencies has issued instruction to companies to make changes to marketing authorisations and the EMA is re-distributing UK work to other member states. (8,9) This already has an impact for companies in terms of making changes to existing licences.
People
D8. The UK’s position as leader in life sciences is underpinned by the ability to attract and retain a highly skilled workforce. The ABPI and BIA welcomed the announcement that the UK has reached an agreement with the EU on citizen’s rights (10). This agreement will provide EU citizens and their families living in the UK certainty about their rights after we leave the EU, and allow them to stay in the UK.
D9. The Government’s expected White Paper on Immigration should seek to create an immigration system that is needs- based, straightforward and rapid. It should facilitate ease of movement for scientists, researchers and highly skilled workers, maintaining current systems such as the Intra-company Transfer process.
Funding
D10. The ABPI and BIA further welcomed the UK Government’s commitment to underwrite funding beyond the date the UK leaves the EU for Horizon 2020 projects approved while the UK is an EU member (11). Subsequently, we welcome the joint agreement with the EU Government that the UK will continue to participate in the Union programmes financed by the Multiannual Financial Framework (which includes Horizon 2020) until their closure (12).
D11. However, the future beyond 2020 is uncertain. The UK/EU government joint report from December 2017 stated the UK “may wish to participate in some Union budgetary programmes of the new MFF post-2020 as a non-Member State”. Access to EU R&D funding could be retained, for example, through the UK gaining “associate member” status for Horizon 2020’s successor (as achieved by Switzerland and Israel for Horizon 2020). This would also allow UK-based academics to lead and participate in EU-wide collaborations (13).
Implementation Period
E1. The ABPI and BIA welcomed news that an implementation period had been agreed until December 2020. This implementation period should be a single step process which adequately reflects the time needed by pharmaceutical companies to move to a new framework.
E2. However, as an implementation period remains subject to the final agreement, we need rapid clarity on the legal position of medicines during the implementation period from the EU and UK. In addition, we need progress on how the desired close cooperation will work in practice.
Trade
E3. Due to the existing integrated nature of cross European supply chains and to ensure continued supply in medicines, the UK and EU should seek to negotiate free and frictionless trade of pharmaceuticals and medical supplies.
E4. In 2016, the UK exported €15,816 million of pharmaceutical products and imported €7,768 million. The UK imports around 54% of its pharmaceuticals from Germany, the Netherlands and Belgium. The UK exports 48% of its finished medicines to three EU countries: Germany, the Netherlands and France (14).
E5. In addition, European and UK supply chains are profoundly integrated which affect both finished medicinal products as well as component products. Over 2,600 final medicines have some stage of manufacture based in the UK (14) and 37% of the active substances processed in the UK are included in the World Health Organisation’s list of essential medicines (14).
E6. Should trade between the UK and EU be subject to customs duties, import VAT and border controls (import/export declarations and inspections/goods’ testing), this would cause significant disruption to the supply chain for medicines.
E7. Customs delays have the potential to impact on the availability of medicines for patients. This is particularly relevant for medicines that are time and temperature sensitive, such as cutting-edge cell and gene therapies. Given the importance of such medicines to patients, the Government should take into account the specific requirements of pharmaceutical products when negotiating new customs and trade arrangements with the EU.
E8. Storage and transport of medicines is dependent on having appropriate specialized facilities and skilled personnel which will take time to put in place.
April 2018
1. European Federation of Pharmaceutical Industries and Associations. BREXIT EFPIA survey results [Internet]. 2017. Available from: https://www.efpia.eu/media/288531/brexit-survey-outcome-08112017.pdf
2. PhRMA. CHART PACK Biopharmaceuticals In Perspective [Internet]. 2016. Available from: http://phrma-docs.phrma.org/sites/default/files/pdf/chart-pack-biopharmaceuticals-in-perspective.pdf
3. PM speech on our future economic partnership with the European Union - GOV.UK [Internet]. [cited 2018 Apr 13]. Available from: https://www.gov.uk/government/speeches/pm-speech-on-our-future-economic-partnership-with-the-european-union
4. UK EU Life Sciences Steering Committee. Maintaining and growing the UK’s world leading Life Sciences sector in the context of leaving the EU [Internet]. 2016. Available from: http://www.abpi.org.uk/media/1375/uk-eu-steering-group-report.pdf
5. The negotiators of the European Union and the United Kingdom Government. Joint report from the negotiators of the European Union and the United Kingdom Government on progress during phase 1 of negotiations under Article 50 TEU on the United Kingdom’s orderly withdrawal from the European Union [Internet]. 2017. Available from: https://ec.europa.eu/commission/sites/beta-political/files/joint_report.pdf
6. European Medicines Agency - News and Events - Procedural guidance to help pharma companies prepare for Brexit [Internet]. [cited 2018 Apr 13]. Available from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2017/11/news_detail_002862.jsp&mid=WC0b01ac058004d5c1
7. European Commission. Draft Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community [Internet]. 2018. Available from: https://ec.europa.eu/commission/sites/beta-political/files/draft_agreement_coloured.pdf
8. Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human. Questions and Answers related to the United Kingdom’s withdrawal from the European Union with regard to national authorised medicinal products for human use [Internet]. 2017. Available from: http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/BREXIT/CMDh_361_2017_clean.pdf
9. European Medicines Agency. Redistribution of the UK centrally authorised product portfolio [Internet]. 2018. Available from: http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500247359
10. HM Government. EU citizens’ rights in the UK: Our agreement with the European Union [Internet]. [cited 2018 Feb 2]. Available from: https://eucitizensrights.campaign.gov.uk/
11. Pickard J, Neville S. UK ministers call for post-Brexit co-operation with EU on drugs [Internet]. Financial Times. 2017 [cited 2018 Jan 5]. Available from: https://www.ft.com/content/e3e9ac6a-5f2d-11e7-8814-0ac7eb84e5f1
12. HM Government. Future customs arrangements: A FUTURE PARTNERSHIP PAPER [Internet]. 2017. Available from: https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/637748/Future_customs_arrangements_-_a_future_partnership_paper.pdf
13. HM Government. Continuity in the availability of goods for the EU and the UK: POSITION PAPER [Internet]. 2017. Available from: https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/638958/Continuity_in_the_availability_of_goods_for_the_EU_and_the_UK_Position_Paper.pdf
14. Office of Health Economics. Public Health and Economic Implications of the United Kingdom Exiting the EU and the Single Market [Internet]. 2017. Available from: https://www.ohe.org/system/files/private/publications/Executive%20report%20-%20final.pdf?download=1#