Euro Roundup: Northern Ireland warns of Brexit border strain for pharmaceuticals

The Minister for Health in Northern Ireland has warned “additional bureaucracy and management” created by Brexit is putting a strain on a team that advises on medicines and pharmaceutical issues.
 
Robin Swann, the politician in charge of health in Northern Ireland, framed the problem as a result of the solution Brexit negotiators came up with to avoid the creation of a hard border on the island of Ireland. The solution, the Northern Ireland Protocol, leaves the jurisdiction governed by European Union rules and regulations that are enforced by the Medicines and Healthcare products Regulatory Agency (MHRA). Talking at the Northern Ireland Assembly, Swann outlined issues with the setup. 
 
“It puts an additional strain on the small team that works with my chief pharmaceutical officer on how we assess what medicines are available. While the grace period is useful, it is coming to an end, which puts an additional workload on how we seek to ensure that those medicine supplies and medical devices are there for the long term and not just through the grace period,” Swann said.
 
Swann made the comment in response to a question about the effect of the additional costs on the healthcare budget. One day earlier, Swann was part of a broader debate about a motion that called for the health minister to “resist strongly disruption to east-west trade for medicines and medical products in all circumstances.”  The motion was narrowly voted down but exposed major concerns.
 
The health minister, who voted in favor of the motion, was among the politicians to use the debate to discuss the perceived problems with the current system. Swann used the example of the recent MHRA approval of AstraZeneca’s Tagrisso to make his case.
 
“When a change of licence held by MHRA was approved under Project Orbis, it applied only to Great Britain, leaving Northern Ireland subject to an EMA update, which has not yet happened,” Swann said. The lung cancer drug is available on a compassionate use basis in Northern Ireland, but the case has raised concerns on both sides of the Irish Sea about the prospect of drug availability diverging.
 
The situation will become more complicated when the grace period ends later this year. Talking to the Financial Times this week, Steve Aiken, outgoing leader of the Ulster Unionists, said Northern Ireland will have a “huge price differential” from the rest of the UK if it is no longer able to benefit from the bulk buying power of the union.
 
Debate Transcript, More
 
Switzerland and Germany agree to cooperate on veterinary medicine regulation
 
The Swiss Agency for Therapeutic Products (Swissmedic) and a German authority have entered into a memorandum of understanding (MoU) to support closer cooperation on veterinary medicines.
 
Swissmedic said the MoU will provide a formal basis for working with Germany’s Federal Office of Consumer Protection and Food Safety (BVL). The MoU will support the exchange of information and work by Swissmedic and BVL to understand each other’s regulatory frameworks, requirements and processes. Swissmedic said the MoU “has major strategic importance for Switzerland.”
 
The decision to work together more closely comes in the run up to the application of the Veterinary Medicines Regulation, which is due to take effect in January. Swissmedic singled out the regulation as one reason that the cooperation with BVL is important.
 
BVL provided additional details in its statement, explaining that the two markets are closely linked, in part because manufacturers ship products with German-language labels in both countries. As such, BVL said close cooperation with Swissmedic is needed.
 
Swissmedic Notice, BVL Statement (German)
 
MHRA seeks feedback on proposed reclassification of Nuromol painkiller
 
MHRA is holding a consultation on whether to reclassify the Reckitt Benckiser painkiller Nuromol. The UK regulator is considering making the product available in shops such as supermarkets, as well as in the pharmacies where it is already sold.
 
Nuromol contains ibuprofen and paracetamol and is intended for use to relieve mild to moderate pain that has persisted despite treatment with either active ingredient individually. The Commission on Human Medicines has advised that the product can be cleared for general sale in shops, leading MHRA to seek the views of the public.
 
MHRA, noting that ibuprofen is not suitable for everyone, is particularly keen to hear from people who may be affected by the proposed change. Reckitt Benckiser has tried to address concerns that buyers may be unaware the product contains both ibuprofen and paracetamol through the content and design of its label. The effectiveness of the label was validated in two user testing studies. 
 
The UK regulator is accepting feedback on the proposal until 3 June.
 
Press Release, More
 
EMA updates COVID-19 vaccine document to clarify manufacturing requirements
 
EMA has updated a document that describes the development, evaluation, approval and monitoring of COVID-19 vaccines with additional information on the manufacturing requirements for approval.
 
The updated document states: “For approval, companies must also show that large scale commercial manufacturing produces vaccines of the required quality. Scaling up production and adaptations to commercial manufacturing can continue in the post-authorization phase.”
 
EMA made no other changes to the document, which first went online earlier this year. The rest of the resource provides an overview of vaccine development and approval, from small-scale studies to characterize the production process through to commercial manufacturing and postmarket safety monitoring.
 
EMA Update
 
Germany’s BfArM links sartan contaminated with NDMA to liver cancer risk
 
Germany’s Federal Institute for Drugs and Medical Devices (BfArM) has shared the findings of a study of the potential link between valsartan contaminated with N-nitrosodimethylamine (NDMA) and the risk of cancer.
 
Using routine health insurance data on 25 million people, BfArM and a collaborator looked into the rate of cancer in people who took contaminated valsartan and in the wider population. The study found no raised risk of cancer overall in people who redeemed at least one prescription for valsartan between 2012 and 2017 but did uncover a potential link to liver cancer.
 
BfArM said the increased rate of liver cancer was small but statistically significant. The study did not show a causal link between liver cancer and the use of contaminated valsartan. However, as the liver is the most likely organ for a tumor to develop if oral NDMA exposure is a risk, BfArM said the finding warrants attention.
 
The German regulator said the study suggests the long-term effects of valsartan contaminated with NDMA should be carefully monitored, adding that the observation period of the research was too short to fully assess the cancer risk.
 
BfArM Notice (German)
 
Other News:
 
The European Commission has created a helpdesk to support the introduction of the unique device identification (UDI) system. Through the helpdesk, the Commission aims to help companies meet the UDI requirements imposed by the incoming medical device and in vitro diagnostic regulations. The help desk features answers to common questions and links to guidance documents. UDI Helpdesk
 
AstraZeneca is recalling Bricanyl 0.5mg/ml solution for injection or infusion from the UK because of out of specification results for a routinely tested known impurity. The results were generated during stability testing. MHRA has asked healthcare professionals to stop supplying the affected batch and quarantine all remaining stock. MHRA Notice