What future for the EMA?

It is probably fair to say that few people were thinking about medicines regulation or drugs pricing when they cast their vote on 23 June – regardless of whether they voted to Leave or Remain. The infamous £350m for the National Health Service certainly influenced many, but the genuine consequence of leaving the European Union is likely to be less money for the NHS, not more. I led a debate recently on the future of the European Medicines Agency, to find out more about the government’s plans for the United Kingdom’s new relationship with the EU medicines regulatory framework. Get that wrong, and costs to the NHS will rise.

The EMA has provided an invaluable and largely unsung role over the past two decades, harmonising medicines regulation across the EU, and granting marketing authorisations for medicines across the 28 EU member states as well as the countries of the European Economic Area. Currently the EMA gives companies a mechanism to get a medicine authorised in every EU country at once – providing access to a huge market of 500 million people. The EMA’s activity – simplifying and streamlining medicines regulation – has meant patients in the UK have had faster access to new treatments. For comparison’s sake, new medicines in Australia and Canada come to market between six months and 12 months later than they do in the EU. Based in Canary Wharf, the EMA employs around 900 people, many of whom are EU nationals.

As the home of the EMA, the UK has been well placed to tap into the potential of the growing global pharmaceuticals and life sciences industries. Indeed a quarter of the world’s top prescription medicines were discovered and developed in the UK, and in 2015 the industry in our country was worth £12.7bn. Just this July, Theresa May said it’s ‘hard to think of an industry of greater strategic importance to Britain than its pharmaceutical industry’. The life sciences and pharmaceutical sectors are particularly significant around my constituency of Cambridge and are an integral part of the city’s excellent research base.

Other EU countries are already throwing their hats in the ring to lure the EMA away, and the EMA has stated its location will be decided among member states. Winning the EMA for the UK was a big win for John Major in the 1990s – now it seems we are to give it away. The knock-on effect on the wider life sciences and pharmaceutical sectors are unclear, but few believe it makes it more likely that future investment and relocation decisions will be tilted in our favour by losing the key regulator. Of course, if we were to stay part of the EEA, the process for medicines regulation might remain remarkably similar. That looks increasingly unlikely.

Industry experts warn that breaking ties with the EMA will mean not only the slower release of new drugs, but higher costs to the NHS – quite an irony in light of the promises from the Leave campaign. American and Japanese companies already file in their home markets before seeking approval in the EEA. The UK with its much smaller market would in all likelihood be at the back of the queue.

Talking to businesses and researchers in and around Cambridge, I am becoming convinced the course the government is setting out upon will do us huge harm. The mixed messages from ministers; the government evasive answers to questions; and the sheer scale and complexity of the challenge ahead have done little to provide reassurance. The UK’s work with the European Medicines Agency is essential for patients, for business, for innovation, and for growing our economy. I believe it is essential we seek continued regulatory cooperation in order to ensure the UK’s excellent pharmaceutical and life sciences industries remain open for business. Failure to achieve that means new treatments will be delayed and the drugs bill will rise. That in turn means less money for the NHS – not exactly what people thought they were voting for.

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Daniel Zeichner is member of parliament for Cambridge. He tweets at @DanielZeichner

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