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| Brexit could lead to longer waiting times for new medicines, warn experts | Brexit could lead to longer waiting times for new medicines, warn experts |
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| Leaving the EU could mean it takes several months longer for new drugs and medical devices to become available in the UK, and reduce Britain’s influence in how such products are regulated, experts have warned. | Leaving the EU could mean it takes several months longer for new drugs and medical devices to become available in the UK, and reduce Britain’s influence in how such products are regulated, experts have warned. |
| At present, the European Medicines Agency (EMA), which approves new medicines and medical devices across Europe is based in London. | At present, the European Medicines Agency (EMA), which approves new medicines and medical devices across Europe is based in London. |
| But speaking at a press conference in London, a group of scientists have warned that, should Brexit go ahead, the EMA would relocate to mainland Europe, potentially leaving Britain without a voice when it comes to how medical products are regulated. “There is no question about it, if we were to leave the European Union, the EMA would go,” said Sir Michael Rawlins, chair of the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA). | But speaking at a press conference in London, a group of scientists have warned that, should Brexit go ahead, the EMA would relocate to mainland Europe, potentially leaving Britain without a voice when it comes to how medical products are regulated. “There is no question about it, if we were to leave the European Union, the EMA would go,” said Sir Michael Rawlins, chair of the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA). |
| Related: EU membership accelerates medical innovation and protects patients | Related: EU membership accelerates medical innovation and protects patients |
| The MHRA plays a key role in regulation, conducting around 40% of the scientific evaluations used by the EMA to approve new products. | |
| The scientists also raised concerns that Brexit could mean that pharmaceutical companies may have to re-register large numbers of drugs for the UK market. What’s more, the MHRA is not in a position to take on the burden of regulation should the approval of drugs in the UK no longer be down to the EMA, they add. “We’d have to enlarge ourselves hugely because we’d have to evaluate all new drugs,” said Rawlins. “Not only that, but I don’t know how it would be paid for,” he added, pointing out that companies would expect to pay far less to have a drug approved for the UK alone: currently approval in one EU country means a new drug or device can be used across Europe. | The scientists also raised concerns that Brexit could mean that pharmaceutical companies may have to re-register large numbers of drugs for the UK market. What’s more, the MHRA is not in a position to take on the burden of regulation should the approval of drugs in the UK no longer be down to the EMA, they add. “We’d have to enlarge ourselves hugely because we’d have to evaluate all new drugs,” said Rawlins. “Not only that, but I don’t know how it would be paid for,” he added, pointing out that companies would expect to pay far less to have a drug approved for the UK alone: currently approval in one EU country means a new drug or device can be used across Europe. |
| “If we do leave we need to be very aware of the size of the UK market and the attractiveness of Britain outside of Europe in our industry,” said Melanie Lee, chief scientific officer of the pharmaceutical company BTG plc. “We are 3% of the global market, whereas if we are with the EU we are 27% of the global market.” | “If we do leave we need to be very aware of the size of the UK market and the attractiveness of Britain outside of Europe in our industry,” said Melanie Lee, chief scientific officer of the pharmaceutical company BTG plc. “We are 3% of the global market, whereas if we are with the EU we are 27% of the global market.” |
| There are also concerns that Brexit would make it more difficult to monitor side-effects from new drugs and devices, and that it could take longer for new products to appear on the market in the UK. “If you look at what happens in those countries that aren’t part of the EU, on average it takes longer to get new medicines approved,” said Patrick Vallance, president of pharmaceutical research and development at GlaxoSmithKline. “On average it is 157 days longer for Switzerland, and on average it takes Canada 140 days longer”. | There are also concerns that Brexit would make it more difficult to monitor side-effects from new drugs and devices, and that it could take longer for new products to appear on the market in the UK. “If you look at what happens in those countries that aren’t part of the EU, on average it takes longer to get new medicines approved,” said Patrick Vallance, president of pharmaceutical research and development at GlaxoSmithKline. “On average it is 157 days longer for Switzerland, and on average it takes Canada 140 days longer”. |
| Related: Why I am wrong about Brexit, and you are too | Related: Why I am wrong about Brexit, and you are too |
| “We are in an era now of an unprecedented upswing in the potential to make new medicines - the pipelines are fuller across industry, there are cures coming through that there haven’t really been in the past, the last thing anyone needs in the middle of that is massive regulatory uncertainty,” he added. | “We are in an era now of an unprecedented upswing in the potential to make new medicines - the pipelines are fuller across industry, there are cures coming through that there haven’t really been in the past, the last thing anyone needs in the middle of that is massive regulatory uncertainty,” he added. |
| Simon Wessely, chair of psychological medicine at King’s College London and a founder member of Healthier in the EU, believes that with many healthcare issues common to the global stage, there is little benefit to severing ties with Europe. “If we look at the threats that we have from bugs - whether there is resistance to antibiotics or not - from climate change, from pollution, from tobacco smuggling, from all of these things, we can do everything we possibly can to set our own house in order,” he said. “But unless we act on an EU scale and ultimately a global scale as well, it will be all for nothing.” | Simon Wessely, chair of psychological medicine at King’s College London and a founder member of Healthier in the EU, believes that with many healthcare issues common to the global stage, there is little benefit to severing ties with Europe. “If we look at the threats that we have from bugs - whether there is resistance to antibiotics or not - from climate change, from pollution, from tobacco smuggling, from all of these things, we can do everything we possibly can to set our own house in order,” he said. “But unless we act on an EU scale and ultimately a global scale as well, it will be all for nothing.” |
| But Matthew Elliott, Vote Leave chief executive, said: “The EU has proven that it is no friend of science. The clinical trials directive was devastating for cancer research, increasing costs and delaying the start of trials. After we vote leave, we can invest some of the £350 million we send to the EU every week in science to ensure that the UK continues to lead the field in groundbreaking medical research.” | But Matthew Elliott, Vote Leave chief executive, said: “The EU has proven that it is no friend of science. The clinical trials directive was devastating for cancer research, increasing costs and delaying the start of trials. After we vote leave, we can invest some of the £350 million we send to the EU every week in science to ensure that the UK continues to lead the field in groundbreaking medical research.” |