The associations representing the European and UK pharmaceutical and life science industry have written to the UK and EU chief Brexit negotiators David Davis and Michelle Barnier to underline the importance of securing ongoing cooperation between the UK and EU on medicines regulation, 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 patients across Europe and the UK are able to continue to access safe and effective medicines and that there is no adverse impact on public health, the associations say.
They are pressing their case after two senior members of the UK government broke ranks following the poor showing of prime minister Theresa May in the snap general election on June 8. The UK business secretary, Greg Clark and the Health Secretary, Jeremy Hunt, said they wanted to secure cooperation on the regulation of medicines as part of the Brexit negotiations.
The industry’s letter says, “We would like to explore this possibility to maintain close regulatory ties between the EU and the UK and to begin these discussions immediately.”
It is important to set out the preferred position at this early stage given the significant time pressure to ensure that the necessary arrangements are in place to secure patient access to drugs, and avoid any adverse impact on public health and patient safety in both the EU-27 and UK, after the UK leaves the EU.
EU-UK partnership on the regulation of medicines
The industry is at risk because it 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 drug regulators. “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 letter says.
The maintenance of previously granted European marketing authorisations both in the UK and the EU, and the continued cooperation between national drug regulators 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.
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) makes the largest contribution of any national regulator to the operations of the European Medicines Agency (EMA) and its withdrawal would mean a loss of capacity and expertise for the network of bodies involved in the review of new drugs, as well as the capacity across Europe for the surveillance and safety supervision of products.
To replace MHRA’s expertise, the EMA will need a capacity building exercise that would lead to duplication of assessment work at EU and national level. UK-based staff working on pharmacovigilance 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 drugs.
In the case of an unorderly withdrawal of the UK there is a risk that all goods due to be moved between the UK and EU could be held either at border checks, in warehouses or manufacturing and/or subject to extensive retesting requirements. This would lead to a severe disruption of most companies’ supply chains.
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. 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 drugs regulators which 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,” the letter says. “Alongside an adequate implementation period, this will ensure that patients continue to have access medicines after 29 March 2019.”
The signatories, including Nathalie Moll, Director General, The European Federation of Pharmaceutical Industries and Associations; John Brennan, Secretary General, EuropaBio; Adrian van den Hoven Director General, Medicines for Europe; Mike Thompson, Chief Executive, the Association of the British Pharmaceutical Industry; and Steve Bates
Chief Executive Officer, UK BioIndustry Association, say they are committed to a continued and open dialogue with Barnier and Davis and are ready to contribute their expertise to the negotiations.