Mr. Michel BARNIER
Chief Negotiator Task Force for the Preparation and Conduct of the Negotiations with the United Kingdom under Article 50 TEU
European Commission R
ue de la Loi / Wetstraat 200
1049 Brussels, Belgium
Rt. Hon David DAVIS MP
Secretary of State Department for Exiting the European Union
9 Downing Street
SW1A 2AG London
Brussels and London, 13 July 2017
We are writing to you as the associations representing the European and British pharmaceutical and life science industry (AESGP, EFPIA, EuropaBio, Medicines for Europe, ABPI, BGMA, BIA and PAGB) to underline the importance of securing ongoing cooperation between the UK and EU on medicines as part of the negotiations to agree a new relationship between the UK and the EU.
Securing such an agreement is the best way of ensuring that patients across Europe and the UK are able to continue to access safe and effective medicines and to ensure that there is no adverse impact on public health.
EU-UK partnership on the regulation of medicines
As you will be aware, our industry is highly integrated across Europe, and regulated under EU law through a sophisticated system of legal and regulatory arrangements between EU institutions, Member States and national competent authorities. It is important that there is as much certainty as possible, as early as possible, to enable the pharmaceutical and life science industry to transition smoothly into the new framework, ensuring there is no disruption to patient access to medicines.
The recent letter published by the UK Business Secretary, Greg Clark MP and the Health Secretary, Jeremy Hunt MP, signalled an opportunity to secure cooperation on the regulation of medicines as part of the negotiations. We would like to explore this possibility to maintain close regulatory ties between the EU and the UK and to begin these discussions immediately.
The maintenance of previously granted European marketing authorisations both in the UK and the EU, and the continued cooperation between national competent authorities as facilitated by the EMA and European Commission, will be important in achieving this. Similarly, any changes to the EU-UK trading relationship should not adversely affect the research, development, manufacture and supply of medicines across Europe, including for clinical trials.
Securing such a cooperation agreement would be in the best interest of public health and patient safety. The UK’s MHRA currently makes a significant contribution to the work of the European regulatory network (EMA, HMA, CHMP, CMDh), and its withdrawal would mean a loss of capacity and expertise for the network for the review of medicines as well as the capacity across Europe for the surveillance and safety supervision of products. A capacity building exercise would be needed leading to duplication of assessment work at EU and national level. UK based Qualified Persons Responsible for Pharmacovigilance (QPPV) would need to be relocated, trained or replaced. This would have an overall impact on the running of the systems that ensure the safety and efficacy of medicines treating EU patients.
An implementation period that adequately reflects the time needed by pharmaceutical and biotech companies to transition to a new framework should be agreed on by negotiators. This will allow companies time to make the necessary arrangements to avoid any unintended consequences on the availability of the medicines that patient rely on, both in the UK and the EU-27. For example, pharmaceutical and biotech companies may need to submit applications for the transfer of marketing authorisation for specific products, move batch release for products or move personnel into the EU-27 from the UK, all of which would take a significant amount of time.
An implementation period will also be necessary for national competent authorities who need to ensure they are adequately resourced to deliver the procedures and maintenance activities associated with the new regulatory framework.
We are confident that, with your support, an agreement can be reached which provides for an EU-UK partnership on the regulation and supply of medicines. Alongside an adequate implementation period, this will ensure that patients continue to have access medicines after 29 March 2019.
As stated above, our organisations are committed to a continued and open dialogue with you and your officials and are ready to contribute our expertise to the negotiations in order to ensure patients are able to continue to access the medicines they need, and avoid adverse impact on public health across Europe. We also continue to engage in constructive conversations with EU and UK regulators to ensure that there can be a successful transition to new arrangements as determined by the negotiations. A continuing role for the MHRA in the EMA’s committees and processes during this transition would be valuable for the continuity of the EMA’s operations.
We look forward to hearing from you and would very much welcome the opportunity to set up meetings with your services for in-depth discussions around our priority issues, given our sector’s technicality and complexity.