s of mid-February, leading up to the Brexit deadline on 29 March 2019, the outlook for the exit of the United Kingdom (UK) from the European Union (EU) has been largely viewed with great uncertainty. The UK Parliament’s rejection of the Prime Minister’s Brexit deal twice within two months before the deadline significantly increased the likelihood of a “no-deal” Brexit, casting even greater doubt and anxiety among people and businesses in UK and EU. Outside of Europe, stakeholders in Asia-Pacific are no less concerned about the potential rippling effects for the region, which would be even more difficult to predict.

Key Takeaways

• Understand different Brexit impacts across the medicines, medical devices, and cosmetics sectors.
• Be proactive with your regulatory authorities regarding possible impacts.
• Be patient with your regulatory authorities as they may also be navigating the post-Brexit environment.
• Be flexible–we still don’t know what sort of Brexit we will get.
• Be aware of knock-on effects (e.g., impacts on pricing, packaging, and translations).
• Keep up to date (i.e., via industry associations etc.).

Brexit’s Impact on Healthcare Systems

To provide the context of Brexit, Mr. Ranson outlined various possible Brexit scenarios–examples including a “no-deal” Brexit, a call for a second referendum, and comprehensive re-negotiations. In view of the unpredictable ways that Brexit has progressed, both speakers voiced the same opinion: It is presently impossible to predict the final outcome.

Describing the current place of the UK within the EU therapeutics sector, the speakers highlighted UK’s key role in contributing to R&D, pharmaceutical products and market value, as well as regulatory functions and responsibilities undertaken by the UK Medicines and Health products Regulatory Agency (MHRA). Referencing various publications by the European Federation of Pharmaceutical Industries and Associations (EFPIA) on preparing for Brexit impacts, Mr. Adams underlined the industry’s perspective, which strongly emphasized the need for flexibility and practicality in making Brexit-related changes (i.e., changes should be administrative in nature and delivered within transition periods).

Other areas within the UK and EU therapeutics sector that would likely be affected are:

• Supply chain: Shortages of medicines imported into UK, especially in the event of a ‘no-deal’ Brexit.
• People: Loss of about 25 percent of manpower within the European Medicines Agency (EMA) due to relocation of operations outside of UK.
• Research: Impact to management of ongoing EU multi-centered clinical trials that are UK-sponsored, as well as UK participation in new trials in the post-Brexit era.
• Regulatory activities: Delays to EMA’s regulatory timelines due to loss of manpower; good Manufacturing Practices (GMP) inspections and pharmacovigilance activities across the UK and EU borders may be affected due to delinking of MHRA from EMA.

What This Impact Means for Asia-Pacific

Given the vast uncertainty surrounding the Brexit situation and its wide range of impact on all sectors in UK and EU, the exact implications for those outside EU remain unclear and under-discussed. Insights from the speakers’ presentations and from discussions during the panel session elicited several points of consideration as possible implications for the Asia-Pacific therapeutics sector.

• Likely impact on international regulatory cooperation activities due to scaling back of EMA priorities may lead to downstream impact on public health and regulatory progress in Asia-Pacific.
• Likely impact on Asia-Pacific markets with regulatory approvals based on UK or EU-issued Certificate of Pharmaceutical Product that may undergo Brexit-related changes.
• Likely impact on import and export of therapeutics between UK, EU, and Asia-Pacific markets; this impact may be disproportionate across the region.
• Likely impact on medical technology sector with respect to medical devices CE marking strategy for EU market access (i.e., expect transitional changes to Notified Bodies due to Brexit as well as the new EU Medical Device Regulations).

The panel stressed that despite the expected impact of Brexit on EMA’s manpower, timelines and priorities, the EMA’s position with respect to the level of stringency of regulatory assessments and openness to innovation would remain unaffected.

Continued International Collaboration

Plan for Uncertainty, Look for Opportunity