For more than two years now, there has been genuine fear and concern about whether Northern Ireland will still have access to 80 percent of its medicines it receives from the UK, including certain statins and drugs for Parkinson’s disease.
The post-Brexit agreement between the UK and the EU, known as the Northern Ireland Protocol, meant that Northern Ireland was still under the European Union’s pharmaceutical regulatory regime. The EU has acknowledged that this causes practical problems and has changed some laws to ease the situation, but the problems remain.
Of the 597 products approved by the UK Medicines and Health Products Regulatory Agency (MHRA) for the UK since the start of 2021, only eight have also been approved for Northern Ireland under the same name and company, the Nuffield Trust said in a report published in January of this of the year.
The number of products currently available in Scotland, England and Wales but not in Northern Ireland, such as the generic version of the Parkinson’s disease drug ropinirole and the generic version of the statin rosuvastatin calcium, are “probably in the triple digits.” the report says. .
With the new Windsor scheme, almost all concerns about the supply of medicines from the UK to NI have been alleviated, health experts say, and the deal has exceeded their expectations in terms of addressing potential long-term problems.
Under a landmark deal announced by the UK and the EU on Monday, drugs will run on the green lane from the UK to Northern Ireland, meaning drugs approved for use by the UK regulator will automatically be available in Northern Ireland. The deal effectively restores the British drug market.
“This is very important and beyond my expectations,” said Mark Dayan, head of the Brexit Nuffield Trust program. I.
He said: “This is pretty much moving Northern Ireland out of the pharmaceuticals single market and into the UK market.
“There was indeed a problem of non-approval of medicines for Northern Ireland, but it was at a fairly early stage. If this continued, you could be in a place where there are fewer generic drugs in Northern Ireland and a greater risk of supply shortages.”
Mr Dayan said that the Windsor Framework, together with previous EU actions, if adopted, would “solve almost all problems”.
He said: “Approvals, testing, packaging and safety are valid without additional controls on both sides of the sea. The confusion about deferred requirements and the idea that pharmacists are dealing with multiple regulatory regimes is no longer needed.
“The downside is that Northern Ireland will no longer have access to medicines authorized by the European Union. We recently saw evidence in our Health and International Relations Monitor funded by the Health Foundation that the UK is generally slower in approving new innovative products: some advanced or cheaper products for cancer and autoimmune diseases may be available in the Republic of Ireland but not in Northern Ireland.
Last week, a House of Lords committee learned that the “biggest factor” in the ongoing supply problems was the application of the EU’s Falsified Medicines Directive (FMD) to Northern Ireland, but not to the UK. Industry representatives highlighted issues such as the additional work involved in monitoring FMD compliance and the shortcomings of the proposed “dual regulatory regime”.
The FMD is a set of rules to protect people in the EU from counterfeit medicines. It includes additional protection against package counterfeiting and drug tracking by a unique identifier, for example. B. barcode. The provisions of the FMD will no longer apply in Northern Ireland, according to the Windsor Framework, eliminating red tape that would slow down the supply of medicines from the UK.
The British Association for the Pharmaceutical Industry (ABPI) said the agreement offers “the robust solution our members have been asking for.”
Richard Thorbett, CEO of ABPI, said: “Pharmaceutical companies now need the right time to implement any necessary changes, and we need to carefully consider the transition period for these changes and ensure that new guidance becomes clear as soon as possible. is and will be provided. if it is possible.
“In addition to specific measures to regulate medicines, the good news is that work could begin on the UK’s integration with Horizon Europe, which will help realize the UK’s aspirations to become a center of science.”
Source: I News
I’m Raymond Molina, a professional writer and journalist with over 5 years of experience in the media industry. I currently work for 24 News Reporters, where I write for the health section of their news website. In my role, I am responsible for researching and writing stories on current health trends and issues. My articles are often seen as thought-provoking pieces that provide valuable insight into the state of society’s wellbeing.