Brexit will have a wide ranging impact on the lives of everyone, including people living with a muscle-wasting condition. This includes the way new medicines are regulated, arrangements for reciprocal healthcare rights, and accessing EU research funding programmes and EU-wide networks. What we know about each of these is discussed in more detail below.
The trade deal agreed between the UK and EU on 24 December 2020 starts to address the structures and processes which will now be in place after the transition period ended on 31 December 2020.
There will be more discussions between the UK and EU across all aspects of the future relationship. Therefore, further details will emerge over forthcoming weeks and months and we will provide updates when relevant information is released.
We are also monitoring and acting upon any issues which arise regarding medicine supplies, either within the UK or between the UK and EU.
The Medicines and Healthcare products Regulatory Agency (MHRA) will now take decisions on new medicines previously made by the European Medicines Agency (EMA), apart from in Northern Ireland, which will continue to follow the decisions of the EMA.
‘Centrally Authorised Products’ already in place (i.e. medicines such as Translarna for Duchenne muscular dystrophy or Spinraza for spinal muscular atrophy already granted a Marketing Authorisation by the EMA) have been automatically converted into UK Marketing Authorisations within the MHRA from 1 January 2021 to create a smooth transition for existing medicines.
The trade deal aims to ensure that there is mutual recognition and co-operation on regulation of products. Therefore, we hope that through the MHRA’s new and existing processes, there will not be any unnecessary duplication of procedures for pharmaceutical companies marketing medicines to both the UK and EU.
For many regulatory requirements, medicines signed off in the EU will be accepted in both the EU and UK.
It is also encouraging to see a clause in the deal which includes: “The Parties shall endeavour to cooperate with a view to strengthening, developing and promoting the adoption and implementation of internationally agreed scientific or technical guidelines”.
Reciprocal healthcare rights
In the Protocol on Social Security Coordination included in the agreement, people temporarily staying in another country – such as UK nationals on holiday in the EU – will have access to necessary healthcare, under arrangements similar to the existing European Health Insurance Card (EHIC) scheme.
A new UK Global Health Insurance Card (GHIC) will be available, replacing the existing EHIC. However, people will still be able to use their EHIC when travelling to the EU, as current cards will remain valid until their expiry date. The details of the GHIC are still being worked out.
Research funding programmes
When the UK was a member of the EU, researchers in the UK led and participated in research funding programmes, such as Horizon 2020 and its predecessors. These programmes provided support for collaborative research in laboratories across the EU, including the UK.
As we know, collaboration and sharing of ideas is vital to drive forward research. Previous programmes have helped establish the TREAT-NMD network (which Muscular Dystrophy UK has worked closely with to promote patient registries and establish best practice care guidelines) and support the SKIP-NMD project (a phase I/II clinical trial in Duchenne muscular dystrophy using Golodirsen to skip exon 53).
The pioneering work of the SKIP-NMD consortium, with which Muscular Dystrophy UK has been involved, has helped develop methodologies and technologies that will benefit future clinical trials for Duchenne muscular dystrophy.
In addition, since completion of the trial, the FDA in the United States of America has accepted Golodirsen for the treatment of Duchenne muscular dystrophy in people who have a confirmed mutation of the dystrophin gene that is amenable to exon 53 skipping. These are two examples of how collaborative EU research funding programmes have benefited people with muscle wasting conditions.
The UK is intending to participate in the new research funding programme, Horizon Europe, and there will be further details on how this will be put into practice once regulations establishing the programme are settled.
There will be a set of terms and conditions for participation in the programme, and the UK will pay a participation fee towards administration costs of the programme.
European Reference Networks
European Reference Networks (ERNs) are virtual networks which link specialist health professionals and centres of expertise across Europe. They aim to facilitate discussion on complex or rare diseases and conditions that require highly specialised treatment, and concentrated knowledge and resources.
UK-based healthcare providers ceased to be members of the ERNs as of 1 January 2021. The John Walton Muscular Dystrophy Research Centre in Newcastle had previously been the lead centre for the neuromuscular ERN.
We hope that there will be some mechanisms established for continued collaboration even though formal membership has end.
Muscular Dystrophy UK has been a member of the neuromuscular ERN, and we expect that patient representatives representing UK patient organisations in the ERNs can continue to be involved in the work of the Networks.
Catherine Woodhead, Chief Executive of Muscular Dystrophy UK, said:
We welcome the news that a deal has been reached between the UK and the EU. While there will be significant changes to the way medicines are regulated and processes for accessing research funding and sharing best practice on healthcare provision, it is encouraging to see the inclusion of provisions for co-operation and alignment in the trade deal.
We hope that this will translate into efficient and practical arrangements to ensure that people living with muscle-wasting conditions do not face delays in accessing new medicines and that there will be opportunities for formal collaboration for UK researchers and health professionals. We will be analysing further information which is made available, and alongside other medical research charities, we will be carefully monitoring the impact of Brexit and the trade deal.
In a joint statement Richard Torbett, Chief Executive of the Association of the British Pharmaceutical Industry (ABPI) and Nathalie Moll, Director General, European Federation of Pharmaceutical Industries and Associations (EFPIA), together representing the EU and UK pharmaceutical industry, said:
We have always said that a deal is in the best interest of patients in the UK and the EU. This means ongoing collaboration in key areas including scientific research and cooperation in areas like medicines safety. We will now take the time to look at the detail to understand what it means for our members and the future of the pharmaceutical industry.