Pharma regulation reforms would ‘heavily impact’ Ireland, Government told

Ireland would be “heavily impacted” by plans to change how the European Union regulates the pharmaceutical industry, Pfizer and other big pharma companies have privately warned Taoiseach Simon Harris.

The pharmaceutical sector lobbied for the Government to push back against parts of proposed EU regulations that would cut down the number of years companies have to sell new drugs they develop before generic competitors can enter the market.

In an April 12th letter to Mr Harris, US drugmaker Pfizer asked the Government to be a “strong advocate” for the pharma industry during EU negotiations on the reforms. The industry is a major employer in Ireland, with a large concentration of companies such as Pfizer, Johnson & Johnson and Novo Nordisk based in the country.

Deb Mangone, the head of Pfizer’s Irish operation, said the planned reforms would shape the sector “for the next couple of decades” and would “heavily” impact Ireland. “We appreciate the Government position to date and we hope that the Government will continue to advocate for pro-innovation policies,” she wrote.

The European Commission, which is the executive arm of the EU, proposed the changes last year, with draft legislation currently winding its way through the lengthy Brussels policymaking process.

Industry had pushed back on proposals to lower the minimum number of years a company has of regulatory protection over its research behind new drugs it develops from eight years to six. Under the proposed changes drugmakers can secure additional periods of protection for their products from generic rivals if they meet certain criteria such as delivering wider accessibility of the drugs across the EU.

Correspondence shows several big players in the pharmaceutical sector sought to lobby Mr Harris on the matter in the days after he became Taoiseach in early April. MSD, another pharmaceutical multinational, lobbied for Government to not just oppose any cut in the number of years companies had exclusive rights over their research data but to go further to “strengthen” drugmakers’ intellectual property rights.

The Irish Pharmaceutical Healthcare Association, which represents the sector, also wrote to Mr Harris in April urging Ireland to argue for greater protections for drugmakers in EU negotiations on the changes. “We have welcomed the Government’s position so far, that is, to underline the need for predictability and stability in intellectual property rights”, the association said.

In a May 15th response to Pfizer Mr Harris said he saw the “merit” in the intentions behind the proposed changes, which were to “address current inequities in market access to medicines across Europe”. The Fine Gael leader said at the same time Ireland believed any changes “must support the competitiveness of Europe’s pharma ecosystem”.

Teva Pharmaceutical, an Israeli multinational firm based in Ireland, also lobbied Minister for Health Stephen Donnelly on the reforms, according to correspondence released to The Irish Times under the Freedom of Information Act.

The company said some elements of the EU proposals would “aggravate” medicine shortages across Europe in a March 8th letter. “Unfortunately we believe there is a misalignment between the political ambition to secure medicines for European patients and the current discussions on some of the pharmaceutical legislation provisions,” the letter states.

The company said the proposed new rules would not help solve the problem of lack of access to medicines.