Brexit diagnosis predicts drug delay for UK patients

Professor Malcolm Macleod believes drug companies will turn first to the European Union to introduce products following Brexit. Picture: Stewart Attwood
Professor Malcolm Macleod believes drug companies will turn first to the European Union to introduce products following Brexit. Picture: Stewart Attwood
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One of Scotland’s leading neurologists has warned that Brexit will delay the newest life-saving drugs reaching patients in the UK.

Professor Malcolm Macleod said that EU withdrawal will make it less likely that pharmaceutical companies developing new treatments turn to Britain when it comes to drug approval.

Speaking to Scotland on Sunday, Macleod said that delays could prove critical for patients facing life-threatening diseases.

According to Macleod, Brexit would see the UK lose out to the rest of the EU when it came to drugs companies choosing the markets to introduce their drugs.

“Part of leaving Europe will be that we leave the European Medicines Agency,” said Macleod. “There is a lot of very appropriate due diligence to make sure drugs are safe and effective. Instead of sharing this work with European colleagues we will either just have to accept what they say, or duplicate all of that work. We know that drug companies seek regulation in the largest markets first and so they are likely to apply for approval for the European market with 435 million people before applying to the UK market with 65 million people.”

Macleod said a study published in 2016 had looked at how long it took new drugs to become commercially available and suggested that market size had a bearing on the speed of the process.

The research published in the American Economic Review found that larger market size when measured by population and GDP per capita was associated with faster distribution of new treatments.

He also gave the example of a life-saving cancer drug which came to market in the EU seven months before it was available in Australia.

“You can see that with a cancer drug called nivolumab – it was approved in Europe seven months before it was approved in Australia, and if you’re waiting for a cancer treatment, those seven months might be very important,” said Macleod.

Macleod, of Edinburgh University, is a practising neurologist who also sits on the Commission for Human Medicines, which advises the UK government on the safety and quality of medicinal products.

He also argued that membership of the EU made drug regulations more efficient and had contributed to patient safety. To support his case he pointed to last week’s decision by the UK government’s Medicines and Healthcare products Regulatory Agency (MHRA) to stop prescribing the valproate drug for epilepsy to women of childbearing age unless they agree to a plan to prevent them from becoming pregnant.

The action was taken in response to concern about birth defects. Since the drug’s introduction in the 1970s, it is estimated that 20,000 children in the UK have been left with conditions like autism and spina bifida.

Macleod said membership of the European Medicines Agency had led to the action being taken.

“One of the benefits of being in Europe is that it makes our drug regulations more efficient. Recent advice that a drug called sodium valproate should not be used in women who might become pregnant came about because of action by the French regulators, acting through the European Medicines Agency.

“Because of this we have been contacting patients to provide them with more information, and I’d encourage women on valproate to discuss this with their doctor or specialist nurse if they haven’t had a chance to do so already. It’s important that they keep taking the medication until they have had that discussion. From a Brexit perspective, the important thing is that being part of the European Medicine’s Agency has made a great contribution to patient safety, even if it’s a contribution that has gone unnoticed by many.”

A Scottish Government spokesman said: “Leaving the EU’s regulatory regime for medicines and medical devices could affect patients, with potential for slower or reduced access to new medicines, equipment or vitally important clinical trials.

“The only way to protect patients, our health and social care services, and our research and pharmaceutical industries is to retain our membership of the Single Market and Customs Union.”

The UK government’s Department for Exiting the European Union referred Macleod’s remarks to the UK health department. A spokesperson for the Department of Health and Social Care said the MHRA would continue to act as rapporteur for both ongoing new applications and in post-approval procedures and would play a leading role in scientific advice procedures in the EMA during the Brexit transition period.

The spokesperson said: “The UK’s position on medicines regulation remains clear: we want to retain a close working partnership with the EU to ensure patients continue to have timely access to safe medicines and medical innovations. We are committed to continuing a close working relationship with the European Medicines Agency

“This was reiterated further by the Prime Minister in her Mansion House speech of 2 March, where she confirmed the government would like to explore with the EU the terms on which the UK could remain part of EU agencies such as the EMA.”