Brexiters' Clinical Trials Conundrum

Brexiters' Clinical Trials Conundrum

The Lords gave a drubbing to Mrs May yesterday on the Customs Union, as you may have noticed if you don’t solely watch BBC News.

But what has gone virtually unnoticed is that the government is in full retreat on the new EU Clinical Trials Directive. This enables novel medicines to be tested across the EU28.

Annabel Goldie, a Tory spokesperson in the Lords, gave the "strongest possible reassurance on the UK’s commitment to implement" the directive.

What she didn’t say is that she was crossing one of her government’s bonkers red lines. Dispute resolution within a clinical trial is ultimately referred up to the European Court of Justice (ECJ) and leaving the court’s jurisdiction is one of Mrs May’s Commandments.

So, why has the government crossed its own red line? Obviously the whole of the life sciences sector – public and private – wants and needs to work with EU27 countries to develop new medicines.

The need arises from the reality of biomedicine today. The age of "blockbuster drugs" has ended and we are at the beginning of the development of new highly targeted drugs. This means that they work very well, but they only work on a small number of patients.

Therefore, to test these new drugs, one needs access to enough of these rare patients to conduct a statistically sound trial. These numbers can only be found efficiently in a very large population like that of the EU28. The UK population is just too small.
So the choice for the UK is stark: either do a bonkers Brexit and destroy our life sciences sector or follow the Clinical Trials Directive and stay under ECJ jurisdiction.

Their Lordships – many of whom have nice portfolios of shares in UK pharma no doubt – saw sense. Even Brexit extremists like Lords Ridley, Lawson and Forsyth saw sense. Either they swallowed their pride on the red lines, or they didn’t quite know what they were doing.

Lady Goldie didn’t refer to the ECJ in her statement on this issue to the Lords. It might have stirred up a hornets’ nest. She just gave her "strongest possible reassurance" on implementing the directive.

And then, to show how tough the government is, she said she couldn’t guarantee the UK would fully join in with the EU27 in designing clinical trials or sharing clinical trial data. This was, she said, a matter for negotiations in Brussels that the UK could not pre-empt.

This is not being tough. It’s being plain stupid. You can’t have a pan-European clinical trial unless you design it together and collect the data together. There’s no point in accepting the EU Clinical Trials Directive unless you intend to work together. And that means give and take.

Annabel Goldie is, however, not stupid. Nor is Mrs May. But maybe they take us for fools.


Author: Martin Yuille, Honorary Reader at The University of Manchester

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