Could UK's post-Brexit regulator evaluate value as well?
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.
