Medicines regulation and law
While the implications of Brexit on drug regulation in the UK are largely unknown, the government needs to consider its options quickly to avoid delaying public access to important medicine.
On 29 March 2017, the UK’s EU representative Sir Tim Barrow hand-delivered the letter signifying the UK’s official intention to leave the EU within two years. In the days since, the European parliament has agreed a negotiating stance and the UK government has released its white paper on the ‘Great Repeal Bill’ to transfer EU laws to the UK. Formal discussions await. In the increasingly likely event of a so-called ‘hard Brexit’, the future of relationships between Britain and the many institutions that have been formed as a result of the country’s 40-year EU membership remains unclear. The UK government has remained vague about what Brexit will really mean, and many decisions must now be taken — for example, on how new drugs will be approved for use and monitored safely in the UK. A preferred post-Brexit model for patient access to new medicines may also be required. The future role of the UK’s drug regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), and how it can unpick the tangled web of mutual reliance with its EU counterpart, the European Medicines Agency (EMA), also remains unclear.
The EMA does not have its own scientific assessor for drugs, but relies on 50 medicines regulatory authorities in the EU/European Economic Area (EEA), including the MHRA, to evaluate drug submissions and monitor safety reports. The MHRA brings a huge amount of expertise and experience to the European drug regulatory landscape, a contribution that is underpinned by its access to comprehensive external advice via the UK’s Commission on Human Medicines and its expert advisory groups across the range of drug disciplines. The MHRA also contributes to the EU regulatory network of national competent authorities in decentralised and mutual recognition procedures. For example, the MHRA is among the countries most commonly selected to account for around 4,000 licensing procedures across the EU/EEA. It is also responsible for about 50% of new marketing authorisation applications submitted in the UK.
Brexit means that the MHRA will lose the benefit of work-sharing for those applications in which it does not act as co-rapporteur at the EMA, which equates to around 70% of new marketing authorisation applications. However, the MHRA has committed to continuing to prioritise a full and active role in regulatory procedures for drugs. If the MHRA is to duplicate the EMA’s work, it would need to substantially increase in size. And such expansion is not cheap.
The UK as a drug market is dwarfed by the EU, which represents 25% of the global market. The UK alone accounts for only 3%, making it of less importance to pharmaceutical and biotech companies when planning product approvals and launches. Recent announcements from GSK and Takeda, headquartered in London and Osaka, Japan, respectively, confirming long-term investments in the UK are encouraging signs for the UK’s place in research and development and manufacturing. But the uncertainty surrounding the future of the UK pharmaceutical industry means confidence is low among industry leaders. One major uncertainty is how European pharma companies can do business with and inside the UK following a hard Brexit. Similarly, there is little understanding of any possible knock-on effect the disruption will have on the global pharmaceutical industry.
The UK is one of the top five European markets, and is part of the core global market for launching innovative new drugs. However, financial problems in the NHS and barriers in its local organisations raise challenges for market access to new drugs, especially for rare diseases. In a report published on 16 March 2017 on access to rare disease treatments, data — collected and analysed by Office of Health Economics Consulting, and commissioned and funded by Dublin-based pharmaceutical company, Shire — showed that the average time to the treatment of rare diseases being funded following EMA authorisation in England is just under 28 months, compared with 9 months in Italy, and almost immediate reimbursement in Germany.
But Brexit will also create opportunities for the MHRA, which should adopt a system of reciprocal regulatory approval if it splits from the EMA. The MHRA’s influence and expertise, and its central involvement in EU regulatory process and granting marketing authorisations, may be a key bargaining point for the UK in any negotiations regarding existing marketing authorisations and future collaborations.
One option for negotiation would be to seek continued mutual recognition, which means the UK would remain as attractive for trials and early drug introductions as it is now. But this would also preclude the UK departing from EU rules on issues such as clinical trials, seen by some as a potential opportunity afforded by Brexit. The EU Clinical Trials Regulation, which aims to harmonise the assessment and supervision processes for clinical trials throughout the EU, is due to come into force in 2018. The regulation provides more streamlined approaches for the multi-centre trial approval process and also provides more coordination between national competent authorities and ethics committees, both of which should benefit sponsors. The UK should consider implementing equivalent legislation in the UK post-Brexit. But to do so, it would need some form of agreement with the EU. Companies conducting clinical trials in the UK would need to prove that they are complying with standards that are equivalent to those in the EU, otherwise these trials would not be able to go ahead because they would be considered to be taking place in a third country.
The UK government may decide to go down the route of divergent regulation, in line with talk of leaving the European single market and standing beyond the reach of the European Court of Justice. If so, the MHRA and NICE may have a role in advising on changes in regulatory processes and on what the UK can do to limit damage to clinical trials and new product introductions. Unilateral recognition of drugs approved in Europe or the United States to retain the UK’s prompt access to new drugs, might be one possibility.
Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2017.20202618
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