The existing EU interpretation of rules surrounding the Northern Ireland protocol could lead to a destabilisation of the supply of medicines not only north of the Border but also in the Republic, pharmaceutical manufacturers have warned.
The representative bodies for the manufacturers of generic and biosimilar pharmaceuticals in Ireland and across Europe, Medicines for Ireland and Medicines for Europe, urged the EU Commission in a letter earlier this week to introduce a derogation of four years – with an option for a further extension – regarding the application of the Northern Ireland protocol.
It said this would allow for time to deal with the current requirement for what is known as the marketing authorisation holder who is seeking to place drugs and medicines on the market in Northern Ireland to be established in either an EU or European Economic Area country or in Northern Ireland itself, but not in Britain.
In the letter sent to EC vice-president Maroš Šefcovic and copied to commission president Ursula von der Leyen, the representative organisations maintained that "the practical implementation of the agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the IE/NI Protocol is causing significant challenges for the pharmaceutical industry with potential severe impact on patients' access to generic medicines in Northern Ireland and beyond".
The representative bodies suggested there could be question marks over the future availability of up to 9,000 products for patients in Northern Ireland .
It said although it appreciated the efforts of the European Commission to implement certain mechanisms to seek to reduce the risk of disruption to medicines supply one of the biggest remaining challenges concerned the interpretation of an EU directive (2001/83/EC) in the annex of the protocol in relation to the marketing authorisation holder.
“For medicinal products authorised via decentralised and mutual recognition procedures, this means that pharmaceutical companies are requested to change existing marketing authorisation holders established in Great Britain to an entity established in the EU, EEA or Northern Ireland in order to continue to serve patients in Northern Ireland. This will have a very significant impact on pharmaceutical operators, with serious regulatory, fiscal, operational and financial consequences.”
Both representative organisations – whose members include companies such as Clonmel healthcare, Viatris and Teva – argued that maintaining a marketing authorisation holder status in Britain would not have any negative impact on patient safety as these as well as any in place in Northern Ireland would be supervised by the same regulatory authority for the entire UK.
“The significant and disproportional efforts are required from industry and regulators to undertake the required administrative steps (such as having multiple marketing authorisation holders and filing variations), which will discourage companies from changing the location of the marketing authorisation holder for Northern Ireland and consequently will seriously risk the supply of medicines in Northern Ireland,” the letter said.
“As Northern Ireland is a small market, companies may decide not to proceed with a change in marketing authorisation holder and remove the marketing authorisation in relation to Northern Ireland. Based on our assessment, the request to change the marketing authorisation holder may affect around 9,000 marketing authorisations.
“Ultimately this may destabilise medicines supply not only in Northern Ireland but also in neighbouring countries such as Ireland.”
David Delaney, chairman of Medicines for Ireland, said its members manufactured up to 70 per cent of medicines on the market in Ireland.
He said on Friday that not only medicines but also packaging and packaging content had to be formally authorised before the products could be sold. He said at present the packaging of certain medicines sold in the Republic of Ireland, as well as other smaller English-speaking countries such as Malta and Cyprus, were authorised in Britain.
He said if the issue regarding the marketing authorisation holder was not clarified by the European Commission it could lead to disruption to patient access to certain medicines in Ireland.
Mr Delaney said “Time is fast running out to ensure the medicines policy systems in EU are updated to avoid potential medicines shortages in Northern Ireland. Changes to the EU medicines rule book on administrative issues such as around whether licenses are based in EU or NI, and that being a barrier to continued supply into NI must be settled very soon. The vast majority of medicines used in NI come from other parts of GB, and barriers to that excellent system, due to license locations must be overcome.”
The European Commission has been conducting rounds of discussions with industry bodies, pharmaceutical companies, and British government authorities as it prepares to put forth proposals on how to ease the trade of medicines into Northern Ireland in the coming weeks.
EU rules are set to be changed to allow regulatory compliance activities to take place in Britain on medicines that are destined for the internal market.
It would mean that pharmaceutical companies that are supplying Northern Ireland would have to follow EU standards and label such medicines as destined for Northern Ireland alone.
However, both the UK government and pharmaceutical bodies have pushed for more in the proposals. The commission maintains the problems the industry is concerned about would not materialise if its solution was implemented.
