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Maintaining the access to medicines

Since the vote for Brexit in 2016, there has been the possibility of the UK leaving the EU without a deal. Consequently, to avoid disruption if supply routes from the EU were affected, the Government asked pharmaceutical companies to stockpile an extra six weeks’ worth of medicines.

This became more pertinent when the leak of the Operation Yellowhammer document (on worst-case, no-deal planning) warned of ‘significant disruption lasting up to six months’ at ports.

But with the Withdrawal Agreement now ratified by both the UK and EU, this scenario seems less likely.

However, one aspect that is subject to change is the regulation of medicines in the UK.

At present, The Human Medicines Regulations 2012 (which incorporated an EU directive into UK law) determine the licensing, manufacture, advertising and sale of medicinal products.

Moreover, membership of the EU has meant that the UK has been part of a simplified, marketing authorisation system for medicines that is run by the European Medicines Agency (EMA), but with input from, for example, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).

Furthermore, together with evaluating applications for new treatments and monitoring their safety, the EMA is also responsible for the Clinical Trials Information System, a key component of the EU’s new Clinical Trials Regulation.

The problem here is that pharmaceutical companies, when faced with a choice about where to launch a treatment, would likely opt for the bigger EU market over the UK.

Thus, there would likely be delays in UK patients receiving new medicines. Indeed, past analysis by the Office of Health Economics revealed that access could be held up, on average, by two-three months, while the proportion of submissions for authorisation as a whole could reduce (based on the experience of other non-EU countries, such as Switzerland and Canada, with whom the EU has a mutual agreement on regulated products).

Any scenario leading to a delay in access to medicines would clearly be unacceptable for our community.

As a result, in its negotiating objectives on the future relationship with the EU, the Government is seeking ‘mutual recognition of certificates of Good Manufacturing Practice (GMP) compliance issued by the regulatory authority of either party.’

These certificates demonstrate that a pharmaceutical company has attained the minimum standard required when producing a medicine, and are required if marketing authorisation is to be subsequently obtained.

Meanwhile, the Medicines and Medical Devices Bill, first advertised in December’s Queen Speech, sets out the principles for a new, post-Brexit regulatory framework. Indeed, it would enable the MHRA ‘to go even further in developing innovative regulation’ for the manufacture and trial of medicines. This suggests that there could be a more divergent approach from that of the EU.

In addition, the Department of Health and Social Care has added: “The new bill means hospitals can use patient tissue and DNA samples to tailor treatments to individual patients when other medicines have failed, or to develop drugs that have a shelf-life of minutes and would otherwise be unavailable to them. This has the potential to streamline access to treatments for patients with rare cancers and brain tumours.”

The level of cooperation that the UK will have with the EMA going forward is unknown. Indeed, the Government has withstood efforts by the House of Lords to dictate its future relationship with the agency.

The Brain Tumour Charity believes that the UK should have continued cooperation with the EMA following the transition period. However, it is promising to hear about the positive impact that the Medicines and Medical Devices Bill could have for those affected by a brain tumour, including the personalisation of treatment. We will update our community with further information on this when it is provided.