HDA UK Media And Political Bulletin – 10 February 2017
BBC Health, Ross Hawkins, 10 February 2017
The former UK regulator Sir Alasdair Breckenridge has said that access to new cancer drugs could be affected if Britain leaves the EU’s medicines regulator. Health Secretary Jeremy Hunt suggested that the UK will depart from the European Medicines Agency (EMA), with the Department of Health saying that Brexit offers new opportunities to bring prompt access to new drugs.
Sir Alasdair told BBC Radio 4’s Today programme: “The UK market compared to the European market of course is small and they may decide not to come to the United Kingdom. “So therefore there will be delay in getting new drugs – important new drugs, anti-cancer drugs, anti-infective drugs – for patients in the UK.”
David Jeffreys, the vice-president of Eisai – a Japanese drugs firm that employs 450 people in the UK, and who also speaks for the trade body the Association of the British Pharmaceutical Industry (ABPI) – said the ABPI wanted the UK to agree a co-operation deal with the EMA, even if it did not remain part of the EU system. The EMA is answerable to the European Court of Justice, and Prime Minister Theresa May has affirmed that the UK must be outside the court’s jurisdiction. The Today programme can be found here, with the EMA item at 07:50.
Pharma Phorum, Richard Staines, 9 February 2017
GSK’s outgoing CEO Sir Andrew Witty says the government must carefully consider post-Brexit drug regulation. He presented a balanced view: departing from European regulatory framework offers opportunities, if the risks are managed. Witty said “The EMA has to make sure that disruption does not lead to new products delayed or affect monitoring of patient safety.” Joint regulation and health technology assessment has been discussed in Europe for years but progress has been slow as reimbursement arrangements are decided by member states, preventing a single assessment system. Witty voiced his trust in the European Commission to ensure that this disruption is kept to a minimum; his comments followed a warning from AstraZeneca’s chief executive, Pascal Soriot, who said that European authorities could ban the UK from harmonising with the EMA and force it to regulate drugs independently.
Chan weighs in on clinical ‘Gold Standard’
Politico, Giulia Paravicini, 10 February 2017
World Health Organization Director General Margaret Chan told a conference in Seattle this week that “regulatory agencies everywhere must resist the push to replace randomized clinical trials, long the gold standard for approving new drugs, with research summaries provided by pharmaceutical companies.”
Some argue this change “would speed up regulatory approval, lower the costs to industry and get more products on the market sooner,” Chan said. “This kind of thinking is extremely dangerous … Don’t let politicians, the public, or industry forget the lessons from the thalidomide disaster.” The WHO circulated Chan’s comments, criticising those who have suggested that the Food and Drug Administration should be overhauled.
There is no Parliamentary Coverage.
BBC Health, Ross Hawkins, 10 February 2017
Patients in the UK could face delays getting new drugs if Britain withdraws from the EU’s medicines regulator, ministers have been warned.
Former UK regulator Sir Alasdair Breckenridge said new cancer drugs could be among those affected.
Health Secretary Jeremy Hunt said he did not expect the UK to remain within the European Medicines Agency (EMA).
The Department for Health said Brexit offered new opportunities to bring timely access to new drugs.
Sir Alasdair told BBC Radio 4’s Today programme: “The UK market compared to the European market of course is small and they may decide not to come to the United Kingdom.
“So therefore there will be delay in getting new drugs – important new drugs, anti-cancer drugs, anti-infective drugs – for patients in the UK.”
The EMA authorises drugs for use across the EU and is currently based in the UK, although it is expected to leave after Brexit.
Sir Alasdair – who was the chairman of the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for almost a decade – said companies could be slower to seek permission for Britain alone, as they may need to pay for a separate assessment of their product for use in the country.
His concerns echo those expressed by the current MHRA chairman Professor Sir Michael Rawlins, who said the UK could be at the back of the queue behind Japan, the US and the EU when drugs are introduced.
In previously unreported comments in January, he told peers: “One of the biggest worries I have about Brexit and standing alone as a regulator is that we are only 3% of the world market for new drugs and if we are not careful we are going to be at the back of the queue.”
The UK needed to carry out regulation more efficiently to cope, he added.
‘Two Year Delays’
In January Jeremy Hunt said he did not expect the UK to remain within the EMA but was “hopeful” of being able to continue working closely with the regulator.
“Separate regulatory arrangements” would be put in place, he added.
David Jeffreys, the vice-president of Eisai – a Japanese drugs firm that employs 450 people in the UK – said British patients could face delays of up to two years.
He said: “The early innovative medicines will be applied for in the USA, in Japan and through the European system and the UK will be in the second or indeed the third wave so UK patients may be getting medicines, 12, 18, 24 months later than they would if we remained in the European system.”
Mr Jeffreys, who also speaks for the trade body the Association of the British Pharmaceutical Industry (ABPI), said they wanted the UK to agree a co-operation deal with the EMA, even if it did not remain part of the EU system.
The former chief executive of the MHRA, Sir Kent Woods, said he believed an agreement could be reached between the UK and the EU for drug regulation in the future, but was concerned about the issue getting absorbed in a wider debate about trade terms.
Moving the EMA from London could put its work overseeing the safety of medicines imported from outside the EU at risk, he added.
The Department of Health said ensuring patients have timely access to safe and effective medicines remains a priority for the government.
A spokeswoman added: “In fact, Brexit brings opportunities in this area, and we will be focused on whether we can secure even faster access to the latest innovations for British patients.
“So we are already taking action to ensure the UK continues to be a world leader and our cross-agency Brexit taskforce is considering the future regulatory roles the MHRA could adopt.”
The EMA is subject to rulings by the European Court of Justice, and Prime Minister Theresa May has said the UK must be outside the court’s jurisdiction.
Pharma Phorum, Richard Staines, 9 February 2017
GSK’s outgoing chief executive Sir Andrew Witty says the government must think carefully about post-Brexit drug regulation – but believes there are some creative possibilities.
In his final results conference as CEO of GSK yesterday, Witty said there are risks, but also benefits as the UK disentangles itself from the European regulatory framework.
Health secretary Jeremy Hunt last month said he expects the European Medicines Agency to move in a meeting with MPs.
Hunt added that the UK will leave the European regulatory system in order to ensure it’s not subject to decisions from the European Court of Justice after Brexit.
Witty told journalists in the conference call: “I assume that if the EMA moves it will create more disruption.”
“The EMA has to make sure that disruption does not lead to new products delayed or affect monitoring of patient safety.”
However Witty said he trusted the European Commission to ensure that this disruption is kept to a minimum.
Witty predicted that the new-look UK regulator will likely work closely with Europe, along the lines suggested by Hunt in a meeting with the health select committee.
Hunt suggested a mutual recognition system where the UK regulator can quickly adopt decisions taken by the EMA.
“There is an opportunity for the UK to create its own shape of regulatory agency. I think it will be wise for the agency to try and get recognition with other agencies like the EMA,” said Witty.
However approval of drugs in the UK could be delayed if the national regulator “asks one question and Europe asks another question.”
“The government has to think very carefully about this,” he added.
Witty’s comments follow a warning from AstraZeneca’s chief executive, Pascal Soriot, who said that European authorities could ban the UK from harmonising with the EMA and force it to regulate drugs independently.
Europe could block harmonisation
Negotiators may decide that harmonisation would allow the UK to “have its cake and eat it” after Brexit, warned Soriot.
But Witty also highlighted potential advantages of having a smaller, national body. This could lead to “streamlined” discussions about “value for money as well as safety and efficacy”, said Witty.
As well as becoming frustrated with NICE refusing to sanction NHS funding for drugs, pharma have long been concerned about the length of time it can take for the cost-effectiveness body to make its decisions, which can drag on for months if there are further negotiations on price.
A system where cost-effectiveness data is gathered at the same time as safety and efficacy data allows for simultaneous decisions on approval and pricing.
Joint regulation and health technology assessment has been discussed in Europe for years but progress has been slow as reimbursement arrangements are decided by member states, preventing a single assessment system.
However Witty has put forward these suggestions for some time, but hasn’t gained wider industry support. This is because many leaders believe the separation of value assessments and pricing negotiations is more favourable to the industry than a single all-powerful market access agency.
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