Drug supply in Ireland “could be destabilized” by EU position on Northern Protocol

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The EU’s current interpretation of the rules surrounding the Northern Ireland Protocol could lead to a destabilization of the drug supply not only north of the border but also in the Republic, the drugmakers have warned.

Representative bodies of generic and biosimilar pharmaceutical manufacturers in Ireland and across Europe, Medicines for Ireland and Medicines for Europe, urged the European Commission in a letter earlier this week to introduce a four-year waiver – with a option for a further extension – regarding the application of the Northern Ireland Protocol.

He said this would leave time to process the current requirement for what is known as the Marketing Authorization Holder seeking to bring medicines and medicines to the market in Northern Ireland to be established in an EU or European Economic Area country or in Northern Ireland itself, but not in Great Britain.

In the letter sent to the Vice-President of the EC MaroÅ¡ Å efcovic and a copy to the President of the Commission Ursula von der Leyen, the representative organizations affirmed that “the practical implementation of the agreement on the withdrawal of the United Kingdom from Great Britain and Northern Ireland the European Union and the IE / NI protocol poses significant challenges to the pharmaceutical industry with potentially serious impact on patient access to generic medicines in Northern Ireland and beyond. of the “.

Representative bodies have suggested that there may be question marks over the future availability of up to 9,000 products for patients in Northern Ireland.

He said that while he appreciates the efforts of the European Commission to implement certain mechanisms to reduce the risk of drug supply disruption, one of the biggest remaining challenges concerns the interpretation of a EU directive (2001/83 / EC) annexed to the protocol vis-à-vis the marketing authorization holder.

“For medicines authorized through decentralized and mutual recognition procedures, this means that pharmaceutical companies are invited to change existing marketing authorization holders established in Britain to an entity established in the EU, l ‘EEA or Northern Ireland to continue serving patients in the North. Ireland. This will have a very significant impact on pharmaceutical operators, with serious regulatory, fiscal, operational and financial consequences. “

The two representative organizations – whose members include companies such as Clonmel Healthcare, Viatris and Teva – argued that maintaining a Marketing Authorization Holder status in Great Britain would have no impact negative on patient safety, as they and those in place in Northern Ireland would be supervised. by the same regulatory authority for the whole of the UK.

“Significant and disproportionate effort is required from industry and regulators to undertake the required administrative steps (such as having multiple Marketing Authorization Holders and filing changes), which will discourage companies from changing the location of the Marketing Authorization Holder for Northern Ireland and therefore seriously risk the supply of medicines to Northern Ireland, ”the letter said.

‘As Northern Ireland is a small market, companies may decide not to change the marketing authorization holder and withdraw the marketing authorization for Northern Ireland . Based on our assessment, the request to change the marketing authorization holder may concern around 9,000 marketing authorizations.

“Ultimately, this could destabilize the supply of medicines not only in Northern Ireland, but also in neighboring countries such as Ireland.”

David Delaney, president of Medicines for Ireland, said its members manufacture up to 70 percent of the drugs on the market in Ireland.

He said on Friday that not only the drugs, but also the packaging and contents of the packages had to be officially authorized before the products could be sold. He said that at present, the packaging of some drugs sold in the Republic of Ireland, as well as other smaller English-speaking countries such as Malta and Cyprus, is allowed in Britain.

He said that if the question regarding the marketing authorization holder was not clarified by the European Commission, it could lead to a disruption of patients’ access to certain medicines in Ireland.

Mr Delaney said: “Time is running out to ensure that medicines policy systems in the EU are kept up to date to avoid potential drug shortages in Northern Ireland. Changes to the EU Medicines Regulation on administrative issues such as whether licenses are based in the EU or in NI, and this being an obstacle to continued supply of NI must be resolved very quickly. The vast majority of drugs used in NI come from other parts of Great Britain, and the obstacles to this excellent system, due to the location of the licenses, must be overcome. “

The European Commission has held rounds of talks with UK industry bodies, pharmaceutical companies and government authorities as it prepares to present proposals on how to facilitate the trade in medicines in Northern Ireland in the coming weeks .

EU rules are expected to be changed to allow regulatory compliance activities to take place in Britain on medicines for the internal market.

This would mean that pharmaceutical companies supplying Northern Ireland would have to follow EU standards and label these drugs as intended only for Northern Ireland.

However, the UK government and pharmaceutical agencies have pushed for more in the proposals. The commission maintains that the problems that preoccupy the industry would not materialize if its solution was implemented.

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