By David Pye, Honorary Policy Officer, Biochemical Society and Derry Mercer, member, Biochemical Society Policy Advisory Panel
On 20th November 2017, the European Medicines Agency (EMA) announced that it would be relocating to Amsterdam from London with the intention of commencing operations on 30th March 2019 at the latest. The choice of Amsterdam was no great surprise to anyone, except possibly for a few Milanese. The EMA, based in London since 1995, currently employs almost 900 staff and it is hoped that many will move with the EMA to their new headquarters taking with them their €322 million annual budget. In addition to the loss of the EMA, there will be the loss of trade for companies associated with the approximately 40,000 business visits the EMA receives each year.
Therefore, it is certain that the EMA will leave the UK, but what is not clear is whether the UK leaves the EMA. It is obvious that the creation of a stand-alone UK regulator would require significant levels of expertise, resources, and perhaps most significantly, time. Eighteen months is not a long time to create a new regulator from nothing. The UK, therefore, runs the risk of falling behind the EU, US and other markets for the approval and launch of new drugs. This will be to the obvious detriment of the ultimate end-users, the patients. The EMA represents a market of over 500 million people, whereas the UK represents only 65 million. Would a new UK regulator be able to get the same pricing deals as the EU? If not, this has clear cost implications for the already creaking NHS and, again, the sick and unwell.
Impact on Industry
It is interesting that after an initial period of relatively quiet reflection, since November’s relocation announcement, industry is now beginning the process of lobbying the government on the issue of how the UK deals with the decision to move the EMA and our potential withdrawal from its regulatory framework. Earlier this month, two of the giants of global Pharma, AstraZeneca and Eisai both openly called on the UK government to commit to continued oversight over the movement and safety of drugs by the EMA when the UK leaves the EU. It seems unlikely at this stage that big Pharma will attain their preferred option of the UK remaining in the EMA, however, it does remain on the table along with numerous other choices. It has also been intimated that at least three senior government figures have let it be known that they hope that the UK remains regulated by the EMA, including the business secretary Greg Clark (according to the Financial Times), although this would appear to be in breach of one of Theresa May’s ‘red lines’ from her Conservative Party Conference speech in October 2016. However, 15 months is a long time in politics.
Many suggestions have already been received on the options for dealing with the situation, such as a mutual recognition agreement that allows the UK to work with the EMA. Perhaps a more ambitious option, suggested by the Nuffield Foundation, would be to allow pharmaceutical companies to approach either the current UK regulator, the Medicines and Healthcare Products Regulatory Agency, or the EMA with a new product. The regulator would then carry out an assessment and the recommendations would then be made to both the UK government and the EU commission. This would require an agreement that each policy making body would abide by the decisions of either regulatory body. Hence allowing decisions made by a UK regulator to be under jurisdiction by UK courts, and as such outside the influence of the European Court of Justice (ECJ). This model would represent a way around the UK government’s current refusal to be subject to ECJ jurisdiction once the UK leaves the EU and works for countries such as Norway, Iceland and Lichtenstein.
Some of the consequences and costs to the UK biopharmaceutical industry have already been laid out here, but others require our consideration. For example, the UK is a net exporter of medicines to the EU (45m packs exported compared to 37m imported each year), but will this continue if alternatives are available from EU suppliers? Trade barriers could make this situation even worse. According to the Life Science Industry Coalition, SME’s in the UK employ an international workforce, with up to 30% of R&D staff being non-UK EU nationals and these figures being up to 20% in larger companies. Will it be possible for this to continue, or will the anticipated “brain drain” affect industry as well as academia?
Brexit also has the potential to create significant uncertainties related to the framework regulating intellectual property (IP) and regulatory exclusivity rights for pharmaceuticals, especially those in development. IP costs are already significant, especially for SMEs, but if there are now to be two regulatory authorities, this cost will only increase. Additionally, the regulation of generic/biosimilar pharmaceuticals remains unclear.
Impact on Patients
Approximately 30 million people in the EU suffer from rare diseases and applications for orphan designation are examined by the EMA Committee for Orphan Medicinal Products. Presumably, the UK will require an equivalent committee, but the market size will be significantly smaller. Will it be a commercially viable option for biopharma companies to apply for orphan designation in the UK compared to the EU? Will this also impact on clinical trials, not just for orphan drugs, but for all investigative drugs? Will this be a loss of income for the NHS and the Contract Research Organisations (CROs) that maintain a significant presence in the UK. The NHS cannot leave the UK, but what is to stop the CROs from relocating along with the EMA?
We shouldn’t forget that Brexit will no doubt provide opportunities for beneficial changes to the regulations governing medicines approval and perhaps expedite decision making. One example might be the control of EU Paediatric regulation, which allows pharmaceutical companies to exempt children from clinical trials of new adult cancer therapies, using a waiver system, even if there is evidence that the medicines could work on patients of all ages. This leads to the 1,800 children a year diagnosed with cancer in the UK being denied access to the very latest cancer drugs that may potentially benefit their condition. Some progress has been made in revising the regulation governing the waiver system, although this has been painfully slow and despite the beginning of EU consultations last year, little has changed to date. Rather than changing the rules the European commission has simply set up another review of legislation, which could take two or more years just to report back, resulting in at least another 3,600 patients in the UK missing out on potential cures for their cancer. Hopefully this is one situation that might be addressed more expediently through a new regulatory framework within the UK. There will no doubt be other examples that offer further glimmers of hope to the process of leaving the EU, but clearly the biggest problems facing the UK medicines regulatory process won’t easily be solved.
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