Mark Samuels, Chief Executive of the British Generic Manufacturers Association (BGMA), said: “While the sentiment of what the European Union has put forward in its latest non-papers concerning medicines and the Northern Ireland Protocol is moving in the right direction, the proposal isn’t practical. Regrettably, the EU’s solution is unworkable because it does not provide legal certainty for manufacturers if the negotiations fail and it includes practical barriers to allowing Northern Ireland to be supplied with the same packs as the rest of the UK.
“Our industry thrives on simplicity and efficiency as margins are typically razer thin. So while we welcome the recognition that quality control laboratories, for example, don’t need to be duplicated on the ground in Northern Ireland, there remains a convoluted process that the Commission proposes that will not work in practice.
“First and foremost, the MHRA needs to be able to grant UK-wide licences; the GB and NI elements of the licence to be assessed together in the same way. This ability needs to be an enduring solution so that – if the UK and EU diverge on medicines regulation – it doesn’t immediately break any agreement. We believe that MHRA should assess and maintain the majority of licences without the necessity to participate in EU DCP or MRP procedures. Otherwise, the further work created by what is, in reality, managing a separate Northern Ireland dossier will, in most cases, render sustainable supply unviable because of the additional complexity for both industry and regulators. It’s a question of feasibility.
“The impact is already being seen. Several thousand products are already on notice with the UK health authorities for discontinuation. In addition, Medicines for Europe, which represents the industry at the EU level, has assessed the number of new licences in which Northern Ireland has been included as part of a Europe-wide Marketing Authorisation application in the first half of this year. Northern Ireland only accounts for 38 out of 771 new MA submissions, which is extremely low. It ranks Northern Ireland as the second-lowest in the EEA region after Iceland, a country with a population one fifth the size of Northern Ireland.
“The BGMA’s own October survey of its members shows that hardly any companies have filed for a specific standalone Northern Ireland new medicines licence. Without a UK-wide licence, these are the only routes available to licence medicines to Northern Ireland. These findings reiterate that to supply Northern Ireland, a UK-wide licence approach is the only sustainable solution. This will easily meet EU standards as the MHRA and EU regulators apply the same policy on safety, quality and efficacy which is all that really matters to patients.
“For all these reasons, there must be a pragmatic solution agreed with politics set-aside. Last month, European Commission Vice President Maros Šefčovič said he would do ‘whatever it takes’ to guarantee the supply of medicines. We share this commitment, but we rapidly need movement towards a practically workable solution.
“We would urge both sides to intensify discussions in the coming weeks and return with an agreed way forward which allows these issues to be dealt with quickly and with certainty. If this cannot be achieved, we would support medicines being removed from the protocol if mutually agreed. Manufacturers want to keep supplying medicines, and any decision to withdraw will be made with the utmost reluctance. However, at present, the proposals from the EU place too many barriers in the way of an established system that has always functioned well and for the benefit of patients in Northern Ireland and the rest of the UK.”