The Commons recently passed New Clause 17 - making it a negotiating objective for the Government to secure an international agreement, through which the UK may continue to participate in the European medicines regulatory network partnership, between the EU, EEA and European Medicines Agency. It ensures that patients continue to have access to high-quality, effective and safe pharmaceutical and medical products, fully aligned with the member states of the EU and EEA.
Being part of the European Medicines Agency means that when a new drug is developed, a common set of protocols are followed to get that medicine approved. It also means the safety of medicines are assessed throughout the EU – important for rare diseases and infrequently-used medicines, and patients are provided with independent impartial advice.
The UK is a world leader in pharmaceuticals and biomedical sciences. We have been the driving force behind the EMA, which has provided significant employment and revenue here in London, and has helped raise and maintain standards for patients throughout Europe.
The loss of the EMA from London takes with it nearly 900 jobs, a turnover of 322 million euros (built from charges, so taxable), and 40,000 business visits every year, all of which have supported local hotels, restaurants, taxis and the entertainment industry. We are also likely to lose the industry that congregates around the EMA for easy access to the regulator. It is a substantial loss of finances, talent, infrastructure and influence – one of the many costs of Brexit.
But even though we have lost the EMA, we still have the chance to be part of the European medicines regulatory network partnership, and still benefit from the work of the EMA. There are three big markets for new drugs in the world – the United States, Japan and the EU. Companies already have to follow different processes to get their drugs approved in these countries. But together with the EU we are part of a single powerful block that represents 22% of the global pharmaceutical market. Companies prioritise getting their drugs to us, because we provide a single European system.
If we leave the EMA, we have only 3% of the global market. Quite simply, we won’t be a priority for new drugs.
Switzerland and Canada have separate approval systems and are typically six months slower than the EU to bring new medicines to market. That’s the cost of leaving the EMA: a six month delay. Try explaining to a patient that a new life-saving cancer drug won’t be available to them because we left the EMA.
Our life sciences industry isn’t complaining about EU ‘red tape’ – they like the common system. According to the Association of the British Pharmaceutical Industry and Bioindustries Association: “Creating a standalone UK regulator would require significant resource, time and expertise, and… would likely still leave the UK behind the US and EU for new product launches, to the detriment of UK patients.”
We are leaving because people voted to leave the EU. But how many people knew that when they voted to leave the EU they voted to increase the cost of new medicines regulation - a cost that will be passed onto the NHS? Or to reduce the UK’s international influence and excellence in this area of life sciences, and delay access to new drugs for cancer patients?
New Clause 17 asks that we take all necessary steps to continue to participate in the European medicines regulatory network partnership. We could do this by remaining members of the EU, by becoming a member of EFTA or by negotiating an associate membership of the EMA.
We are already seeing the high cost of Brexit to the NHS. We’re seeing an exodus of EU staff making recruitment challenges much harder, and we see the huge threat to the supply chain if we leave the Customs Union. And now we face delays in cancer patients getting new drugs, while our former EU partners continue to benefit from the system that we used to lead.
It doesn’t have to be this way.
I am pleased that Parliament has passed this clause, to put the interests of NHS patients above Brexit ideology, and to remain part of the European medicines regulatory partnership.