How will the UK Pharmacovigilance market survive and thrive post-Brexit?

Amidst changes to the many laws altered by Brexit is uncertainty over the pharmacovigilance market. With time passing and the likelihood of a full withdrawal increasing, what shape will the medical and pharmacovigilance industry take with the UK leaving the European Union?

 

Concerns arise over the state of what is a significant industry with large spending power behind it. The intricacies of EU law and the requirements of pharmacovigilance spending and activities may be altered completely in the years to come, with pharmaceutical organisations no longer required to perform testing within the UK. UK providers of pharmacovigilance services may find themselves in the dangerous position of not being asked or required to undertake medical studies.

At present, the EMA (European Medicines Agency) is responsible for the running of PRAC – the Pharmacovigilance Risk Assessment Committee. This regulatory body is critical for ensuring an appropriate level of pharmaceutical standard within the European Union; a service that may no longer be required should a full Brexit scenario occur.

A matter of time

 With the United Kingdom not expected to confirm exit from the European Union for at least a year, the pharmacovigilance market remains somewhat as normal in the interim. The full range of legal obligations and arrangements continue in the short term.

The level of damage done to the pharmacovigilance market once this date passes will depend on the nuances of EU and UK negotiation. Of importance is the matter of the European Economic Area (EEA); if the UK remains within this agreement, minimal disruption to trade and the status of the industry is expected.

The alarming scenario is therefore that the UK leaves the EEA. Should this occur, the disruption and changes resulting will be far-reaching. The strong history of medical and life sciences research and investment that the UK enjoys may be impacted, with its desirability in R&D funding and testing lowering considerably.

The UK may find itself left outside of the important EU Clinical Trials Regulation that is due in October 2018. Aimed at reducing administrative and overhead costs of clinical trials and applications for research, this regulation involves the standardisation of medical databases and more, bringing a currently complicated system towards a more streamlined approach that reduces costs and speeds process. Should a ‘hard’ Brexit occur, the UK will not benefit from this.

Data complications

 A problem specific to the potential hard Brexit scenario is that of data access. In addition to the Clinical Trials Regulation mentioned above, the pharmacovigilance system as it exists now is coordinated and managed by the EMA on behalf of European countries. Should the UK fully leave the EU, it would subsequently have access to a smaller range of data sets, in addition to increases in PV cost and knowledge sharing with Europe.

This issue of data and ownership applies further to intellectual property, as laws surrounding this within Europe are governed on a territorial basis. In a hard Brexit scenario, it is feasible that companies within the pharmaceutical industry may cease imports of products into the UK due to the ownership of intellectual property such as patents. This greater strength in law could damage UK pharmaceutical trade if responding legislation is not swiftly implemented.

Speculation continues

 While the above points provide something of a guideline for the future of the pharmacovigilance market within the European Union, there is only so much to be gained by speculation at this point. With so many elements of intellectual property, data access and patent ownership depending on the UK’s final Brexit decision, it remains a waiting game.

The potential for damage to the industry is not set in stone; even in a hard Brexit scenario there are legal steps and responses that may be taken by the UK to ensure that pharmaceutical companies located in the country are not overly damaged and disadvantaged when compared to their European counterparts. As is the same with many other industries at present, we must wait and see as to how the UK acts in the months to come.