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Brexit, regulatory affairs, and pharmacovigilance: no man is an island

Gibson Research Consultancy

Most of us will agree that there are some things whose importance should transcend politics and borders. There are some basic human rights, such as safety, protection from harm, access to shelter, food, and medicines.

We live in a time where it is possible to provide everyone with these minimum requirements for a decent quality of life. And yet, this utopian idea is far removed from the real situation.

When the UK leaves the EU, it is not only the UK that will bear the consequences. When it comes to medicine regulation, the Medicines Healthcare Regulatory Authority (MHRA) in the UK has played a pivotal role in shaping how medicines are licensed in the EU.

It has been one of the major players in the setting up of the European Medicines Agency (EMA). Therefore, the MHRA has had a say in how medicines are traded and how their safety is monitored across the Member States of the EU. EMA also shares a high level of health information across the EU, thus monitoring communicable diseases and antibiotic resistance across its Members’ territories.

In an ideal scenario, when it comes to Brexit, there would be less disruption in the workings of this fine-tuned regulatory machine if the MHRA operated within the same framework of rules as EMA, where mutual recognition could be facilitated. Europe and Britain alike would thus avoid losing a large area for which it is obtaining health and medicine information, further protecting the patient better within a framework that has been years in the making.

This is only one possible regulatory solution, assuming the two regulatory bodies are aligned. However, this does not chime with the stated desire of many of the real architects of Brexit who are seeking a Britain that is a small government, low regulation country, a “Singapore-on-stilts”. In this scenario, looser UK regulatory affairs could look more like those of FDA, rather than EMA. In this case, mutual recognition will probably not be possible.  

The MHRA has been a major player to both medicines and medical device regulations, as well as pharmacovigilance in Europe. Losing the MHRA could lead to both operational and intellectual gaps. The MHRA was a key driver in developing the idea of user testing of package leaflets and was instrumental in the EMA adopting this as mandatory for all medicine package leaflets from 2005 onwards.

We recall a meeting at BfArM in Germany in 2007 where one pharma representative joked: “Are you bringing the English disease of user testing with you?” This year, in the run-up to the UK’s withdrawal, we have seen a shift in user testing being located outside of the UK. In the past 6 months alone, we have received numerous requests for us to conduct these projects in Ireland.

In the meantime, however, for the sake of preparedness for a ‘worst-case scenario’, EMA left its London premises and relocated its headquarters to Amsterdam in March 2019, taking with it some 900 jobs.

The scope also extends to the Falsified Medicine Directive (FMD) launched earlier this year in February. With FMD, safety features have been added to most prescription-only medicines (POMs) as well as some over the counter (OTC) products considered likely to be falsified. In most cases, a 2D code, as well as an anti-tampering device, have been added. By means of scanners connected within the European network (the repository system), each pack carrying these unique identifiers (UI) can be traced along its journey from the batch release site, to the wholesale dealer, to hospital or pharmacy. When it finally arrives at the patient, it is ‘decommissioned’ or ‘checked-out’ and thus removed from the system, thus confirming its authenticity.

Another disruption that is envisaged is the fact that the UK has been appointed Reference Member State (RMS) by applicants seeking a UK license. For example, in 2017 43% of procedures placed the UK as RMS. This means that it would be the UK, as a European Member State, that would be leading the review of the particular application in a mutual recognition procedure (MRP) or decentralised procedure (DCP).

Both MRPs and DCPs aim at facilitating access to a single market (i.e. the EU) by relying upon the basis of mutual recognition. This is a way to streamline and harmonise procedures whilst maintaining transparency. In essence, several Member States are piggybacking on the UK for licenses for several products, and the pig is about to walk away. This means that a new RMS may have to be appointed from within the member states before the Brexit date, distributing the workload that once belonged with the MHRA.

This centralised procedure is mandatory for all medicines derived from biotechnology and other high-tech procedures, as well as for human drugs for the treatment of HIV/AIDS, cancer, diabetes, neurodegenerative diseases, auto-immune and other immune impairments, and viral diseases, and for veterinary medicines for use for growth or yield (crop) enhancers.

Going forward, it must be kept in mind that once Brexit occurs, certain persons or activities pertaining to the EU or the EEA must be located within such area: marketing authorisation holder (MAH) and applicant, batch control and batch release site, qualified person (QP) and qualified person for pharmacovigilance (QPPV), and the pharmacovigilance site master file (PSMF).

In the case of medical devices, come Brexit date, the legal implication would be that CE (‘conforming with Europe’) markings from British notified bodies will no longer be recognised by the EU. Thus, UK manufacturers of medical devices will be classed as economic importers rather than EU distributors. The notified body would need to be within the EU to maintain the previous status for placing these medical devices on the market. 

Adopting two different regulatory systems (UK vs EU) would result in delayed access to new medicines and medical devices, weaker post-approval regulation and pharmacovigilance, as well as loss in expertise.

By Miriam Calleja, Pharmacist and Author, Malta

and Mark Gibson, Health Communication Specialist, United Kingdom

31st August 2019

Sources:

© 2019 Miriam Calleja and Mark Gibson, protected under British Copyright Law 1988.

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