EU gives green light to shortened protection for medicines

On Thursday night, the EU countries and the European Parliament reached an agreement to clean up the more than 20-year-old EU legislation on pharmaceuticals.

In doing so, Denmark has solved one of the most sensitive tasks during the Danish EU presidency, which runs until 1 January.

Here, Denmark, with a strong pharmaceutical industry led by Novo Nordisk, has had different interests than a number of EU countries in Southern and Eastern Europe, which have primarily wanted cheaper medicine for their citizens.

Minister of the Interior and Health Sophie Løhde (V) believes that it has been possible to reach an agreement that will be “to the benefit of millions of Europeans and strengthens Europe’s ability to develop the medicines of the future”.

– With today’s agreement, we are setting a new direction for European health policy, where we ensure faster access to treatment, less bureaucracy and stronger conditions for a competitive life science industry in Europe, says Sophie Løhde in a written comment.

Danish Industry (DI) believes that the agreement is better than feared, but still a step in the wrong direction from the industry’s point of view.

The central question in the negotiations has been how long the total data and market protection should be for new medicines.

In the United States, the period is 12 years.

This means that pharmaceutical companies have 12 years in which they can make money on newly developed products without competition from copy products.

This is good for the companies, but can be expensive for consumers.

Therefore, a number of EU countries without large pharmaceutical companies have wanted to shorten the period in order to gain faster access to cheap medicine.

The protection period in the EU is currently a total of ten years when a pharmaceutical company launches a new medicine.

This is two years shorter than in the United States.

In 2023, the European Commission proposed reducing the period by two years in its draft for the agreement that has now been reached.

However, with the possibility of extending the period again by two years if the new medicine was launched in all EU member states.

The new agreement does not go that far.

The EU countries and the European Parliament have ended up reducing the total data and market protection period from ten to nine years.

However, with the possibility of one additional year of market protection for “innovative” medicines that meet a number of criteria.

Chief Executive Officer of DI Lars Sandahl Sørensen emphasizes that it is “crucial for Europe’s future that the pharmaceutical industry remains on European soil”.

– That is why we had also hoped for an agreement that would strengthen the current framework conditions. But we fully acknowledge the Danish government’s efforts during the negotiations, he says in a press release.

He adds that with the agreement they have managed to “avoid smashing the conditions for the European life science industry”.

But he sees it as a step in the wrong direction compared with the conditions the United States offers the industry.

Life science primarily covers the pharmaceutical, biotechnological and medical fields.

After the political agreement has been reached, the pharmaceutical package must now be formally adopted at the beginning of the new year.

After that, the member states can begin implementation.