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1st Oct 2023

EU aiming to make medicines cheaper, more available

  • EU Commission vice-president Margaritis Schinas and health commissioner Stella Kyriakides announcing the proposals on Wednesday - but will there be enough time to legislate before the 2024 elections? (Photo: European Commission)
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The European Commission has unveiled long-awaited proposals to cut the price of medicines and get companies to launch new drugs in all 27 EU countries.

Wednesday's (26 April) overhaul of pharmaceutical industry rules, the first in 20 years, comes in the wake of the Covid-19 pandemic.

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The EU executive wants to end massive divergences in access and price between member states and improve access to new treatments.

"It is no secret, that big member states had better chances to obtain faster certain drugs, but this should not create a two-tier approach of first and second class citizens," commission vice-president Margaritis Schinas told reporters, adding that the commission wanted to create a single market for medicines.

It proposed to cut the length of market exclusivity that drugmakers get before competitors, such as generics manufacturers, could enter their turf to eight from 10 years.

But the commission is also planning incentives to push companies to launch drugs across the entire bloc.

Pharma firms would get two more years of regulatory protection if they launch their new medicines in all 27 member states.

The commission hopes this move would provide access to new drugs to around 70 million more citizens.

Europeans spend around 2 to 3 percent of the EU's GDP on medicines.

"While patients in the western and bigger member states have access to 90 percent newly approved medicines, in the eastern part of the EU and in smaller member states, this number as low as ten percent," health commissioner Stella Kyriakides said, adding that it was "unacceptable".

She said the new rules aimed to reward innovation while improving access to medicines.

Although in the EU, the European Medicines Agency (EMA) approves new drugs, member states strike individual deals over pricing and volumes with companies.

In Germany, Denmark, and Austria, for instance, more than 120 new medicines have been available that were approved since 2017, while in Lithuania and Latvia, only 26, and 28, respectively.

Ina further example, the time between marketing authorisation and the date of availability to patients in Germany is 133 days. In Poland, it is 844.

Industry warning

The reforms also aim to prevent drug shortages, such as those seen this winter with critical antibiotics, by requiring companies to notify the EU of possible supply issues earlier.

The EMA will draw up an EU list of critical medicines to strengthen the supply chains of those specific drugs.

The draft will be negotiated between the European Parliament, and EU governments, and the new law could take years to come into force.

When asked if there was enough time for this parliament and commission to complete negotiations before the 2024 European elections, Schinas said the commission hopes "it is adopted as soon as possible".

However, Big Pharma companies argued that, as a result of the draft rules, Europeans could miss out on the newest treatments.

Novo Nordisk CEO Lars Fruergaard Jørgensen said in a statement that "the proposals are poison for innovation and competitiveness in Europe," Reuters reported.

For its part, GSK, another pharma giant, said the EU must "regulate for growth and competitiveness" because companies "have choices on where our capital and resources are focused".

The pressure to weaken market exclusivity protections could discourage companies from researching and launching treatments in Europe, GSK Chief Executive Emma Walmsley warned.

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