Sigma Pharmaceuticals, the Ethical Medicines Industry Group, and the Pharmaceutical Industry Network Group jointly hosted a webinar on the Northern Ireland protocol, yesterday (September 20).

Currently, the protocol means that Northern Ireland has remained in the EU’s single market for goods. Since January 2021, the protocol has mandated that Northern Ireland must follow EU medicine regulations, although there is currently a grace period in place until the end of the year – which the UK extended unilaterally earlier this month (September 6).

Antonia Jeans, head of Northern Ireland Regulatory Policy and Devices Trade at the Department of Health and Social Care (DH) – who was invited to speak at the webinar – gave an overview of the actions the UK government is adopting to tackle the “significant disruption” caused by the protocol.

Ms Jeans told delegates about the UK government’s proposal – set out in a document referred to as a “command paper” – for medicines to be removed from the protocol, which would avoid having “two different regimes across one territory, which is the UK”.

“We are working with the commission to enter into serious discussions on the command paper position,” Ms Jeans said.

 

UK’s unilateral extension to grace period

 

Martin Sawer, executive director at the Healthcare Distribution Association (HDA) – who also spoke at the webinar – said that some of the challenges arising from the protocol include the responsibility for manufacturers based in Great Britain to manufacture separate medicine packs for Northern Ireland to comply with EU regulations.

But there are no “market incentives” for them to do so, as the Northern Ireland market only constitutes 3% of the UK medicines market, Mr Sawer explained. 

While the extension to the grace period has given manufacturers “breathing space”, Mr Sawer said that “HDA member companies believe that, without fundamental mitigation measures being introduced, there could be a significant reduction in the range of medicines available to NHS patients in Northern Ireland”.

C+D reported last week that manufacturers have “formally begun the withdrawal process” for over 2,400 drugs in total in Northern Ireland.

 

Manufacturers urged to rethink discontinuation intentions

 

Ms Jeans confirmed that the EU does not intend to take legal action following the UK’s decision to extend the grace period and that the DH is “confident that [that] provides the breathing space that industries need”.

“We’ve got talks with the Commission underway at the moment and we are thinking to negotiate significant changes to how the protocol works for medicines. We think this will give us the opportunity to find a long-term solution,” Ms Jeans added.

She asked manufacturers to consider whether they have “sufficient certainty to not make plans to discontinue”.

“It really helps with our prioritisation in terms of understanding which medicines are most at risk of supply shortages. There’s a team of pharmacists who have a very difficult job at the DH, who basically have to review every medicine that is at risk of discontinuation to try and find alternatives for patients.

“If there’s any positive sentiment that you have about being able to continue because you feel certainty from what you’ve heard today, then I would urge you to withdraw the discontinuations,” Ms Jeans added.

She said that the DH has already seen some companies stepping back from their intentions to discontinue medicines in Northern Ireland. While she warned that she cannot offer commercial advice on this issue, she said: “We know the EU is intending to pass legislation by the end of the year on those areas, so the picture is looking much more positive than it was”.

“The commission doesn’t want any discontinuation of medicines for patients in Northern Ireland, that’s not their objective and it’s the same for us. We’re working for the same goals,” Ms Jeans added.