House of Commons considers the impact of Brexit on the life sciences sector
The House of Commons Health and Social Care Committee has published a report on the second phase of its investigation into the impact of Brexit on the life sciences sector: “Brexit: Medicines, medical devices and substances of human origin”.
As the UK’s withdrawal from the EU will affect many aspects of the provision of health, social care and the wider life sciences sector, the Committee’s dominant message is that the UK government and the EU should prioritise securing the closest possible regulatory alignment in the next round of Brexit negotiations in order to protect the interests of their respective citizens and the sector itself. The report highlights that the continued supply of safe and effective medical devices, medicines and substances of human origin on the UK market will be very much dependent on continued alignment with European regulations.
The report also expresses concern over the lack of clarity by the government in respect of contingency plans in the event of a “no deal” scenario. The Committee stress the importance of receiving such clarity in order to guarantee patient safety and continued health supplies, relieving the concerns of businesses and patients, which in turn will strengthen the UK’s negotiating position by demonstrating that it has a credible fall-back position. The Committee warn that a disorderly UK exit could result in an immediate impact on the supply of essential medicines and products in the UK and EU-27.
The report sets out specific recommendations to be considered by the government when preparing for Brexit, including:
- Trade, customs and supply chains: to negotiate free and frictionless trade with the EU, to include arrangements to maintain parallel trade in medicines with EU Member States as part of the future EU-UK trade agreement. In the event such an agreement is not possible, the Committee seek clarification from the government in its response as to whether the UK can participate in the WTO Pharmaceutical Tariff Elimination Agreement (which facilitates zero-tariff trade between WTO members) in its own right and whether that WTO Agreement will be updated to include all completed and component pharmaceutical products.
- European Medical Agency (EMA): seeking ‘associate membership’ of the EMA which would bring benefits to the UK and EU alike, to include provision for products to only undergo a single set of approvals in one country, facilitating speedier access to new innovative medicines in the UK and enabling the EU to have continued access to the expertise of the Medicines and Healthcare products Regulatory Agency (MHRA) and the UK’s leading universities.
- Qualified Persons (QPs): seeking agreement with the EU for QPs working in the UK to have their work recognised in EEA countries, to include publishing any contingency plans for a situation in which no mutual recognition of QPs in the UK and EU is agreed to prevent the relocation of UK QPs. The Committee also advise of the need to ensure training and recruitment of new QPs to fill any resulting vacancies.
- Clinical trials: Given that the new EU Clinical Trials Regulation will be implemented after the date of Brexit, the Committee recommends that the government incorporates it into UK law to ensure that patients can continue to participate in the EU clinical trials regime and to clarify the status of UK citizens currently engaged in ongoing clinical trials.
Regulatory alignment over EU rules for data protection: securing lawful data flow, including of personal data for health research and audit between the UK and the EU.
- Research and collaboration: ensuring the UK continues to be a member of EU research and development funding and research mechanisms such as Horizon 2020 and the Innovative Medicines Initiative post Brexit and, if possible, on current terms.
- Access to EU pharmacovigilance systems: seeking mutual recognition with the EU of pharmacovigilance studies by the MHRA and the EMA, to include maintaining membership of all of the major EU pharmacovigilance systems and databases including the European Databank on Medical Devices (EUDAMED) and Eudravigilance. The UK should also look to retain full membership of the Pharmacovigilance Risk Assessment Committee (PRAC),
The Committee report highlights concerns that are widely shared amongst the UK life sciences industry.
The Committee make it clear that regulatory alignment with the EU and the EMA is vital in order for the UK to attract global life sciences companies to research, develop, manufacture and promote new medicines and medical device products. The Committee warn that the UK market is too small to ‘go it alone’ by creating a standalone regulatory system. Nonetheless, manufacturer businesses will still need to consider investing time and money preparing for a ‘no deal’ scenario that may or may not be realised.