Post-Brexit UK Could Lose Access To EU’s Drug Safety Database
Executive Summary
One of the many ramifications of the UK’s decision to leave the EU is that it could lose access to the revamped EudraVigilance adverse drug reaction database.
The UK is likely to lose its access to the European Medicines Agency’s EudraVigilance database of drug adverse reactions as a result of Brexit, unless some sort of agreement for continued access can be reached, experts have warned.
The draft withdrawal agreement that was published by the EU on Feb. 28 states that at the end of any Brexit transition period, the UK “shall cease to be entitled to access any network, any information system, and any database established on the basis of Union law.”
That includes the EudraVigilance database, which was established under Article 24 of EU Regulation 726/2004, says Els Janssens of law firm Baker McKenzie.
EudraVigilance is a key component of the EU drug regulatory system. The EMA’s Brexit preparedness business continuity plan issued last October listed the database as a Category 1 (highest priority) activity and as a core activity supporting the agency’s IT applications, including the clinical trials database, EudraCT.
A new version of the system was launched in November 2017, with enhanced features for the reporting and analysis of suspected adverse reactions, such as simplified reporting, improved searching and tracking, and extended access for marketing authorization holders.
Under the EMA’s access policy, different stakeholders have different levels of access to EudraVigilance, with marketing authorization holders and regulatory agencies of the European Economic Area (the EU plus Iceland, Liechtenstein and Norway) having full access, including to all data elements for individual case safety reports (ICSRs) and spontaneous reports. Non-EEA regulatory authorities, by contrast, have access to only a defined set of ICSR data elements, which are provided to a named contact on request.
As things stand, the UK could lose its current access to EudraVigilance – particularly as the EU has just stated in its draft guidelines on the future relationship that the UK will not be able to participate in the EMA after Brexit, despite suggestions by the government that it could seek “associate membership” of the agency. REF
Derogation Possible?
It is possible that the UK could try to negotiate a derogation or some other arrangement to have access to EudraVigilance, but it is far from clear whether that would succeed.
Janssens noted that Articles 46 and 49 of the draft withdrawal agreement provide for derogations allowing the UK to have access to EU information systems, networks and databases, “but only to the extent strictly necessary to comply with its obligations under the relevant titles.” The information systems, networks and databases concerned will be listed in “Annex Y + 4 which is currently empty.”
However, Article 46 is part of Title II regarding customs procedures and Article 49 is part of Title III on value added tax and excise duty matters, and “these matters are in no way related to the pharmacovigilance activities undertaken under Regulation 726/2004 and Directive 2001/83,” Janssens told the Pink Sheet. “Therefore, I do not see the derogations of Articles 46 and 49 as a potential means to provide the UK access to Eudravigilance.”
“While in theory a hard Brexit would see the UK lose all access to EudraVigilance, things might be different if a softer exit is negotiated” – Bart Colbert, president of BLCMD Associates
Might things change? Possibly, depending on how the Brexit negotiations go. According to Bart Cobert, president of BLCMD Associates, a US drug safety and pharmacovigilance consulting firm, while in theory a “hard Brexit” would see the UK lose all access to EudraVigilance, things might be different “if a softer exit is negotiated. I think the latter scenario is likely in about six months when the panic sets in. Folks will realize little concrete progress seems to have been made.”
Could the UK's Medicines and Healthcare products Regulatory Agency continue to function adequately without EudraVigilance and a whole range of other functions after Brexit? “Yes. They’re starting to work on contingency plans now but I’m not sure this is going too well or too quickly; nor is it clear where the millions of pounds to do this will come from.”
Workarounds
There is the possibility that some workarounds might be found, though. “I think that major efforts will be made to allow the MHRA to continue to use or at least access EudraVigilance and other EMA and member states’ functions but at a heavy cost,” Cobert said. “The technical and logistic work and costs will be very heavy and really would need to start today no matter which path is chosen.”
Janssens noted that the withdrawal agreement was “only a draft and subject to further changes as negotiations progress.”
And while the UK and EU positions on UK participation in the EMA (which would include access to databases such as EudraVigilance) are “very far removed from each other,” she pointed out that Eudravigilance is “directly related to patients’ safety” and “in itself is not related to the integrity of EU decision making or ECJ [Court of Justice of the EU] jurisdiction, which are key drivers for the EU position.”
“I would therefore not exclude that… an agreement could be found on a longer period of access for the UK to EudraVigilance against payment of fees. Even if such access is only on a temporary basis.”
From the editors of Scrip Regulatory Affairs.