BEIS Committee Report Warns of Dangers of Pharma Regulatory Divergence after Brexit
As we heard at the recent packed annual PING seminar that VWV held, there is no bigger issue facing the pharma industry than Brexit, and in particular the uncertainty over what will happen from a regulatory perspective.
Dr Ian Hudson, the Chief Executive of the Medicines and Healthcare products Regulatory Agency (MHRA) set out his vision for a post-Brexit regulatory environment, and the NSF's Dr Pete Gough gave some practical insight into what pharma businesses should be doing to prepare.
However, as the negotiations progress, it is also a matter of providing certainty and the industry's desire for regulatory alignment with Europe. At the PING event, Ian Hudson talked about UK Prime Minister Theresa May's desire for associate membership of the European Medicines Agency (EMA), but much will depend on the negotiations.
Now we have heard concerns from the Business, Energy and Industrial Strategy Committee that the biggest Brexit issue facing pharma is regulatory divergence.
"What little benefits there may be of regulatory divergence would be greatly overshadowed by the costs and loss of markets and influence the UK would face," said the BEIS Committee report. It added: "It makes commercial sense for the UK to remain aligned with standards in the EU market, given the significant amount of trade it provides for both the UK and EU and the access it gives both to medicines."
It strongly urged the Government to pursue that approach, and also to seek clarity from the European Commission regarding possible associate membership of the EMA. It would be important not to replicate manufacturing sites, testing or roles, the BEIS Committee added.
It warned that a separate UK regulatory regime could cost £45,000 for each new drug released, which would see the UK as an unattractive market for new and innovative medicines. It added that no deal could see harmful tariffs for many products with border delays putting time and temperature-sensitive treatments at risk.
Comment
The report chimes with what we are hearing from clients and what was said at the PING event. We hope that a sensible outcome is reached where the EMA and MHRA can continue working together. We feel that that is in the interests of pharma businesses and patients in both the UK and the rest of Europe.