Medicines Cooperation on a Knife-Edge in the English Channel

November 27, 2018
Peter O'Donnell

Applied Clinical Trials

The decision of the leaders of the European Union over the weekend to endorse the Withdrawal Agreement for the UK's departure was historic in that it was the first time ever that the European Council had to face the imminent reality of a member state dropping out.

The decision of the leaders of the European Union over the weekend to endorse the Withdrawal Agreement for the UK's departure was historic in that it was the first time ever that the European Council had to face the imminent reality of a member state dropping out. But historic moments do not necessarily mean decisive moments, and that is definitely true here. As a result, everyone in the healthcare sector with a stake in the future is left as uncertain as before about what is actually going to happen to cooperation between the UK and continental Europe.

For a start, the Withdrawal Agreement is not valid until it is ratified by the UK and European Parliaments-and the chances of that look very slender at present.

In addition, the Withdrawal Agreement, even if it is backed by parliamentarians, says nothing about future links across the Channel, but merely defines the terms of departure.

Alongside it, EU leaders also approved a Political Declaration setting out the framework for the future relationship between the EU and the UK. But this is no more than an expression of vague ambitions, and is not binding on anyone. Any binding effect will emerge only from tough negotiations that will take place between both sides over the next two years, assuming the Withdrawal Agreement wins support. So it brings no certainty either.

What might this mean for people developing medicines? The declaration does contain one last-minute addition that offers some imprecise prospect of some cross-Channel cooperation on product authorization. "The parties will also explore the possibility of cooperation of United Kingdom authorities with Union agencies such as the European Medicines Agency (EMA), the European Chemicals Agency (ECHA), and the European Aviation Safety Agency (EASA)," it says, and "in this context, the United Kingdom will consider aligning with Union rules in relevant areas." There are also expressions of hope over maintaining science and innovation collaboration, cooperation for medicines regulation, and a focus on future trade and customs and borders. 

It's not much. But it's something. Until a week ago, all the frantic appeals from medicines developers to maintain close UK links with the EMA had generated no formal response. Now there is at least a possibility of a pathway to some collaboration. 

The European research-based industry association, EFPIA, was quick to welcome the EU leaders' move. It said it hoped "that the deal is ratified and then immediate and intense focus is given to regulation and supply of medicines in the post-Brexit relationship." In an echo of remarks from across the healthcare community and the life sciences sector, EFPIA said "an explicit commitment to securing long-term, extensive cooperation around the regulation of medicines and medical technologies is in the best interests of patients and public health.

The chief executive of the Association of the British Pharmaceutical Industry, Mike Thompson, who has struck a resolutely optimistic note throughout the two years of the Brexit process and who appears to still take politicians' assurances at face value, said “the terms of the deal mean that medicines will continue to reach the patients who need them when the UK leaves the EU in March." That will be the case, of course, only in the event that everything is agreed-and so far it isn't.

At the UK's BIA, representing biotech firms, the view was rather more cautious-entertaining still (with anxiety) the persisting risk of the UK crashing out of the EU with no deal, and noting that the the UK and EU reaching a deal "improves the chance of stability and increased certainty for business." Its CEO, Steve Bates, points out that after the "disruption, duplication, and uncertainty" the UK’s life sciences industry has already endured, "it’s likely this will continue to be the case for the months ahead." He added: "There is a long way to go from a political declaration on a future relationship to a legally binding, effective and workable future framework."

The stakes are high-and for all the confident bluster from the UK prime minister after she squeezed her last-ditch plan through the European Council, they remain as high now as they were a week ago, and certainty over the future remains as elusive as ever.

 

Peter O'Donnell is a freelance journalist who specializes in European health affairs and is based in Brussels, Belgium

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