Ozempic drug-maker pushed Government to oppose EU pharma reforms

The pharmaceutical giant behind hugely successful weight-loss drugs such as Ozempic and Wegovy pushed the Government to oppose EU reforms aimed at improving access to medicines, internal correspondence shows.

Last April the European Commission proposed a major overhaul of pharmaceutical legislation, which has prompted pushback from the pharma industry. In particular the industry has opposed proposals to lower the standard number of years a company has of regulatory data protection over research behind drugs it develops from eight years to six, which can prevent generic drug competitors entering the market.

Internal correspondence shows Danish drug-maker Novo Nordisk, which manufacture the anti-obesity drug Ozempic, pushed the Government to raise the matter at EU level. The company has seen soaring profits on the back of huge global demand for its next-generation anti-obesity drugs Ozempic and Saxenda, as well as Wegovy, which is not yet available in the Republic.

In an April 25th email, Vincent Clay, head of EU government affairs at Novo Nordisk, told an adviser to Taoiseach Leo Varadkar that the proposed reforms would “harm innovation, investment and ultimately patient care in Ireland”.

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The correspondence asked the Department of the Taoiseach to “consider whether this is an issue that the Irish Government should be communicating its position on” to the European Commission.

The reforms proposed that drug-makers could secure an extra two years of protection for products they developed if they were rolled out in all EU countries where they were authorised within two years. In the correspondence, released to The Irish Times under the Freedom of Information Act, Mr Clay said this was “simply not feasible”.

Lars Fruergaard Jørgensen, chief executive of Novo Nordisk, met Mr Varadkar on May 22nd to discuss the proposed EU reforms. A briefing prepared for Mr Varadkar ahead of the meeting said the industry viewed proposals to link longer protection of intellectual property around new drugs to EU-wide access as “introducing considerable uncertainty”.

During the meeting Mr Jørgensen outlined the pharmaceutical company’s position, which a spokesman said was that the proposed reforms would be a “net negative for both European patients and competitiveness”. Changes were required before the legislation “can be considered fit for purpose to advance patient health and promote an innovative life science ecosystem in Ireland and Europe”/ the spokesman said.

A Department of Health spokesman said that while Ireland supported efforts to improve access to medicines, there were “concerns” with elements of the planned EU reforms. Officials feared the current proposal “may inadvertently lead to a lack of predictability” for pharmaceutical companies, which the department spokesman said would “ultimately impact on patient access” to drugs.

The Irish Pharmaceutical Healthcare Association, which represents the industry, has also been lobbying the Government on the reforms. A spokeswoman for the industry group said Ministers and officials had “listened” to the sector’s concerns. There was a need for “predictability” in the industry to support long-term decisions on investment to develop “much-needed new therapies”.

The internal briefing for Mr Varadkar’s meeting with Mr Jørgensen advised him to raise “the importance of ensuring the supply” of Ozempic into Ireland.

Ozempic is licensed for the treatment of type-two diabetes in Ireland but is also prescribed “off-label” as an obesity treatment. The huge demand for the prescription medication has led to severe constraints on supply in Ireland and intermittent shortages.

Novo Nordisk has recently had to supply one of its other weight-loss drugs, Saxenda, into Ireland in packages with Norwegian rather than English text due to shortages.

Correspondence shows the company sought permission for the change from the Health Products Regulatory Authority on August 18th to “mitigate against” expected shortfalls in supply from early November. A spokeswoman for the company said the product itself was the same, and local pharmacies had been advised of the reason current supplies had arrived with Norwegian labelling.