On 20 September, VWV held a webinar attended by over 100 people across the pharma supply chain, in association with EMIG (the Ethical Medicines Industry Group) and Sigma Pharmaceuticals Plc (one of the UK's leading wholesalers for parallel imports and generics) entitled: "Northern Ireland Protocol Latest: supply, pharmacy and patient challenges - what are the DHSC's plans?"
The setting was against a backdrop of anxiety around the Northern Ireland Protocol across the pharma supply chain and what to do regarding supplies from Great Britain to Northern Ireland, Falsified Medicines Directive compliance, and the Marketing Authorisations and splitting up of products into additional categories. There have been concerns around practically how to supply.
Following the end of the Brexit transitional period on 31 December 2020, there was a one year grace period so that a detailed solution for Northern Ireland could be worked through. However, as 31 December 2021 has been approaching, it has become apparent that there was no solution yet, and instead of Northern Ireland having the best of both worlds in being both within the EU's Single Market /Customs Union AND a part of the United Kingdom, they were at risk of not having vital goods including essential medicines.
At the webinar, we heard from Martin Sawer, Executive Director of the Healthcare Distribution Association, who said the Northern Ireland Protocol meant the supplies of medicines from Great Britain to Northern Ireland was a challenge and would continue to be a challenge unless another solution was found. Martin explained how UK suppliers treat the UK as one market with a hub and spoke system. Only about 20% of medicine is actually stored in Northern Ireland, with the rest transported rapidly within just hours from big hubs, which happen to be in mainland Great Britain. Even if the wholesalers wanted to change the model, there was a lack of warehouse space in Northern Ireland to make that happen.
Due to the challenges of having to have medicines that comply with the Falsified Medicines Directive in Northern Ireland but not in Great Britain, this means subdividing the manufacture, storage and licensing of products. Already, 1,000 product lines were being discontinued with more to come. The HDA were forecasting as much as a 75% reduction in some lines of licensed generics and Over The Counter products.
Helga Mangion, Policy Manager at the National Pharmacy Association, echoed what Martin said with effects on reductions of supply, and noted the impact on pharmacies and patients.
Charley Maxwell from the regulatory specialists, Pharmalex, talked about the different marketing authorisations that were now available, including why people may choose to seek a different MA for Northern Ireland from Great Britain rather than a United Kingdom wide one, if the products were not going to be able to be marketed across the whole country. There was still uncertainty over what was going to happen.
Antonia Jeans, Head of Northern Ireland Regulatory Policy and Devices Trade at the Department of Health and Social Care, then gave a positive outlook. She acknowledged the significant difficulties that the Northern Ireland Protocol was causing for pharma suppliers and patients, and she said they had to get to a place where Northern Ireland had as good access to medicines as the rest of the UK.
The DHSC had proposed in a Command Paper to remove medicines from the Northern Ireland Protocol, and this was something that Martin and Helga, as well as Sigma's Bharat Shah, strongly endorsed. This would be the best way to avoid carving up the market, and ensuring continued supply of medicines to Northern Ireland.
The reason for optimism was the UK had, the previous week, unilaterally declared an open-ended standstill period, rather than the end of the grace period due to take effect on 31 December 2021. This would give more time to work through a proper long-term solution with the European Commission. Constructive talks with the Commission have continued, and, significantly, the Commission responded publicly to say that it was not taking legal action against the UK Government over this unilateral step.
As Antonia said, both sides are coming at this issue from different angles, but they both have the same objective in mind - they want to avoid the discontinuation of medicines to patients in Northern Ireland, and both sides want to make this work. Martin was full of praise for how Antonia and the DHSC had gone about things, and had listened to the concerns that had been raised. In turn, Antonia thanked the industry including the many people who spoke up at the webinar, for providing continued valuable informative insight and evidence to enable meaningful discussions to take place. She asked for the valuable information to keep coming.
Brexit was never going to be totally smooth. The biggest crunch point since the vote in 2016 was the situation in Northern Ireland. The Northern Ireland Protocol was set up to try to provide a solution, but it is clear that its application to pharma will have a real danger of meaning that patients will not get their medicines when they need them.
After some, at times, difficult public pronouncements, the recent developments strongly suggest that common sense, pragmatism and a desire to work together for a common solution has broken out. Antonia confirmed the more positive mood music at the webinar.
It has to be hoped that the two sides will find a way through in a way that recognises the reality on the ground and ultimately meaning that patients get access to all the medicines they need.
Catch up on the recording of the session.
This article first appeared on the C+D website on September 21, 2021.