By Robert Seiler
One of the first concrete signs of Brexit’s approach came late last year when two EU agencies, currently located in London, were sent off to new pastures on the European mainland. In November, an EU-wide vote saw the European Medicines Agency (EMA) relocate to Amsterdam and the European Banking Authority (EBA) move to Paris.
Arguably the biggest prize was the EMA: with a budget of approximately £232 million and 900 staff, the agency also attracts over 40,000 business visitors to the UK each year. That’s a significant economic boon that the UK will surely miss – but Brexit could have a far bigger impact than a monetary one. The question is, can the right solutions be implemented to stave off a crisis?
Ripple effects
While the move is not scheduled to take place until an unspecified date before March 2019, its impact is already being felt. The EMA itself has admitted that the best-case scenario would see 19% of staff resign due to the move. The worst outcome could see up to 70% of employees quit, which could result in a near-shutdown of the system and raise the probability of a wider public health crisis.
Already, the UK Medicines and Healthcare products Regulatory Agency (MHRA) has tried to downplay fears in the pharmaceutical industry about the potential impact of the move, saying that it hopes to continue its relationship with EMA post-Brexit. The statement was intended to smooth feathers in an industry where getting timely approval for new products is crucial for getting new medicines to patients and turning a profit.
Indeed, although the move has yet to take place, its repercussions are already apparent: GlaxoSmithKline, the UK’s biggest drug manufacturer, has announced it will have to divert £70 million from cancer research to making accommodations for Brexit. The company has said that an estimated 1,700 products would be directly implicated by a disorderly Brexit, with new labs and regulation processes costing a minimum of £60 million. GSK has already begun building a new drug-testing facility in mainland Europe as a contingency plan in case Brexit negotiations hit a wall. Given all the adjustments it has to make, the firm has called for expediency in the run-up to March 2019, so it can meet the demands of its customers as seamlessly as possible after the transition.
Registration overload
For its part, though the MHRA has stressed it hopes to maintain close relations with the EMA, it did not rule out the possibility that it may have to establish its own drug rules. Should that occur, it could result in a logistical nightmare in terms of registering British drugs for use in EU countries.
At present, around 2,400 medical products would require authorisation to be marketed and sold in the bloc, which is difficult to achieve while the final outcome of Brexit negotiations remains opaque. Therefore, it’s likely that such registrations will only be submitted once the deal has been finalized. This means that thousands of applications could arrive in the new EMA office in March 2019, culminating in a massive bottleneck.
HTA to the rescue?
As luck would have it, Brussels has already come up with a way to bring new treatments to market more quickly: via the health technology assessment (HTA), a method for policymakers to decide how much their health systems are willing to pay for drugs. Effectively, it involves determining the value of a human life – especially critical in the rare disease market, where prices for treatments are relatively high.
Under the system, the EMA would remain responsible for verifying the drug’s safety, while its worth would be decided by national HTA bodies. Although the EC is chary of standardising pricing across all member states, it does wish to introduce a system whereby member states can access information about a drug’s efficacy prior to negotiating prices and deciding whether to cover it. This would be especially beneficial for smaller countries that do not have the resources to conduct comprehensive investigations on their own.
If it enters into force – a process that could take three years – such a system could help streamline the way patients access new drugs that the EMA has already approved but that member states have not yet decided whether to include for reimbursement. This could be a major boon for patients waiting to access breakthrough treatments, particularly in the expanding field of genetic disease therapies.
For instance, one of the most significant recent advancements in the field was Biogen’s Spinraza (nusinersen), which treats the rare genetic disorder spinal muscular atrophy (SMA). SMA causes progressive muscular weakness and loss of movement due to muscle wasting.SMA affects 40 new-born babies in the UK annually, many of whom cannot perform basic motor functions and often do not survive past age two.
The drug showed remarkable results in two clinical trials, both of which were truncated to allow patient access. However, eight months after the EMA approved the drug, only Sweden and Italy have approved Spinraza for reimbursement. Other EU member states, including the UK, are still deciding whether to cover the drug, leaving many patients without access in the meantime. For instance, some UK patients have been able to receive interim treatment in France while the NHS carries out its assessment – but if the French authorities approve Spinraza with no decision from the UK, these patients’ lives will once again be up in the air.
Time is of the essence
An EU-wide HTA would thus be an effective way to help streamline the lengthy process of achieving EMA approval, securing approval for reimbursement, and getting new drugs like Spinraza to patients. Unfortunately, however, even if wide-reaching advance measures are taken, its positive impact could be eclipsed by the massive disruption that Brexit is set to inflict in the market. With more new drugs in the pipeline than ever before (92 new drugs were given EU approval in 2017), policymakers and industry executives are now in a race against time.
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