Dr Prashanth BSB, head of safety and medical writing for ELC Group, talks to EPM about the ramifications Brexit may have on the pharmacovigilance landscape.
A changing landscape
The legal framework of pharmacovigilance (PV) for medicines marketed within the EU is provided for in regulation (EC) no 726/20041 with respect to centrally authorised medicinal products, and in directive 2001/83/EC with respect to nationally authorised medicinal products (including those authorised through the mutual recognition and decentralised systems).
The EMA has also released good PV practice guidelines (GVP)2 to facilitate the performance of PV activities. These GVP modules replace the volume 9A3 guidelines. The EMA requires that all applicants name a qualified person for PV (QPPV), and set up a PV system master file (PSMF) that describes all aspects of their PV system. The GVP also details requirements for signal detection and management, literature screening and risk management, with requirements which are often more stringent than FDA regulations.
The EMA (unlike the FDA), now requires all serious adverse events — both those labelled and those unlabelled — to be submitted within 15 calendar days to the EMA and other national regulatory agencies, as well as submission of all case reports of non-serious adverse events within 90 calendar days of receipt by a marketing authorisation holder.
In the US, all pharmaceuticals, including drugs and biologics, as well as medical devices, are subject to federal regulations, enforced by the Food and Drug Administration (FDA). During clinical development of a product, the FDA is focused on development of a safety profile and requires, similarly to Europe, the submission of expedited reports for serious and unexpected adverse events and confirmed signals occurring in association with the drug or biologic under development.
Unlike Europe, the FDA is focused on new molecular entities and on serious and unexpected adverse events occurring after marketing. Also, unlike Europe, not all newly approved pharmaceuticals are required to have a risk management plan in place at the time of marketing.
The FDA has a robust signal detection programme in place, and pharmaceutical companies and manufacturers of medical devices are subject to these regulations.
Brexit
On 29 March 2017, the UK government served formal notice under Article 50 of The Treaty on European Union to terminate the UK's membership of the EU. Based on Article 50, the EU Treaties shall cease to apply to the UK and the UK exit will take effect in March 2019 (subject to the unlikely possibility of the withdrawal agreement being concluded sooner and unless all member states agree to extend the period).
In October 2016, the prime minister further announced plans for a repeal bill. The proposed effect of this bill is to convert the current body of EU law into British law. The intention is that this will mean more ‘business as usual’ as the same rules and laws will apply to businesses and workers after Brexit as they did before.
However, notwithstanding the effect of the repeal bill, of arguably greater importance is the current position of the UK not to be part of the European Economic Area (EEA) post-Brexit. As the UK does not intend to remain in the EEA or be part of the European Free Trade Association (EFTA), the effects on the life sciences sector are likely to be substantial. This is because the UK would no longer keep access to many of the benefits of the EU system, such as the centralised procedure for marketing authorisations, the EU portal for clinical trials and the PV database.
Pharmacovigilance
The EU PV system is coordinated by the EMA, which will need to be relocated from the UK following Brexit. UK companies will therefore need to revise their PV reporting system as a single person cannot perform the PV function for the EU and UK, and as the appropriately qualified person should both reside and operate in the EU.
Furthermore, uniform product safety laws, as applied currently across the EU [e.g., the general product safety directive (2001/95/EC)], are likely to continue post-Brexit in common with those of the EU and globally, so as to maintain the competitiveness of UK goods and suppliers.
It is still, however, uncertain what the exact ramifications of Brexit are going to be and we therefore suggest the best policy at this time is to be prepared by keeping up to date as the process develops.
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