Scientists for Labour

Mrs May caves in on EU medicines

Mrs May caves in on EU medicines

Not a whisper as Tory Lords cross Tory red line

The Lords gave a drubbing to Mrs May yesterday on the Customs Union, as you may have noticed if you don’t just get your news off the box.

But what has gone virtually unnoticed is that the government is in full retreat on the new EU Clinical Trials Directive. This sets EU standards for testing novel medicines 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 this is the strongest possible reassurance that Mrs May will cross one of her own red lines. Within a clinical trial, any disputes that arise will be resolved ultimately by the European Court of Justice (ECJ). Yet leaving the court’s jurisdiction is a key government Brexit policy goal.

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 may 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 robust 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 keep a Brexit red line and destroy our life sciences sector. Or follow the Clinical Trials Directive and stay under ECJ jurisdiction.

Their Lordships saw sense. Even Brexit extremists like Lords Ridley, Lawson and Forsyth saw sense, despite the fact that only one of them has a declared shareholding in life sciences. Either they swallowed their pride on the ECJ red line, or they didn’t know that the directive implicitly requires ECJ jurisdiction.

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 ignorant. 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. Annabel Goldie is, however, not ignorant. Nor is Theresa May. But maybe they take us to be.

Martin Yuille

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