March 28. 2024. 10:23

The Daily

Read the World Today

Commission bets on new incentives to improve access to medicines in the EU


The European Commission presented the eagerly-awaited pharmaceutical package on Wednesday (26 April), employing a set of regulatory incentives for the industry to improve patient access to new drugs.

The much-delayed package is designed to ensure that all EU patients have timely and equitable access to safe and effective medicines, regardless of which member state they live in.

“It is the most complex, neuralgic, epic, big package we have prepared in the area of health throughout our mandate,” Commission Vice-President Margaritis Schinas told reporters on Wednesday.

One of the issues is that, according to Commission figures, there is a 90% variance between Northern and Western European countries and Southern and Eastern European countries when it comes to available medicines, according to Commission’s figures.

The number of medicines approved by the EU’s medicine authority EMA and available to patients in Europe as of 2018 varies from more than 100 in Germany, Austria, and Denmark, to only 11 in Latvia, 16 in Lithuania, and 17 in Croatia.

Moreover, the average waiting time across the EU differs from four to 29 months.

“It is not a secret that big member states now have better chances to obtain faster certain drugs,” Schinas said adding that this should not create the illusion of first and second-class citizens.

As a tool to address inequalities, the Commission proposed a new incentive system that “rewards companies that go the extra mile”, in Kyriakides’ words.

This means the shift to a targeted approach rather than the current ‘one size fits all’, as new incentives will be based on certain criteria.

Commenting on the package, Rosa Castro, senior policy manager at the European Public Health Alliance, said current rules do not address the unequal access to medicines across different EU countries.

“Today’s revision is a unique opportunity to rebalance the status quo,” she added.

LEAK: Commission enlists help of stakeholders to reshape EU pharma sector

The European Commission will call for “cooperation between different stakeholders to bring about positive change” in the pharmaceutical sector, according to a leaked communication accompanying the revision of the EU’s drug framework.

New modulation of incentives

As each member state engages in separate discussions with companies to introduce medicines into their markets on the basis of their own particular conditions, Brussels cannot directly regulate this.

To address this, the Commission is offering regulatory protection of up to 12 years for innovative medicines, compared to 11 years of protection in the current system – offering an extra year of exclusive rights on the drug for the marketing authorisation holder.

However, only six years will be granted for regulatory data protection, plus two extra years for market launch.

The partial shortening of the regulatory data protection period will allow generics and biosimilar manufacturers to obtain approval for their products sooner through some form of abbreviated application.

If a company does not reach out to all 27 member states, the market protection for its products would expire sooner.

In addition to the eight years of guaranteed regulatory protection, two years of protection will be given – and even three years in the case of smaller companies – if the new product is launched in all member states.

However, this aspect met with fierce criticism from the pharmaceutical industry.

“The approach set out in the pharmaceutical legislation, penalising innovation if a medicine is not available in all member states within two years is fundamentally flawed and represents an impossible target for companies,” said Nathalie Moll, director general of the EU’s pharmaceutical manufacturers association EFPIA.

The European Patients’ Forum (EPF), for its part, welcomed the proposal to strengthen incentives for faster launch and earlier access to medicines for patients.

In a bid to soften the industry’s stance, EPF stressed that the total duration of incentives, should the necessary conditions be met, will be similar or even higher than the current levels.

Additional years of regulatory protection will be given as a form of incentive for additional therapeutic indications, such as six extra months for unmet medical needs or comparative trials.

The incentives will apply equally to all products regardless of where they are developed – in the EU or elsewhere.

Based on the Commission’s impact assessment, this incentive system would help another 67 million European citizens have access to medicines.

“We will continue to have one of the most competitive and industry-friendly incentive systems in the world because companies can still reach the 11 years of protection they have today. But they can go as high as 12 if they fulfil all conditions,” Kyriakides concluded.

The baton has now been passed to the European Parliament and the EU Council to continue political discussions on the proposal before its approval.

More on the same topic...

EU new pharma rules strengthen efforts in tackling drug shortages

EU new pharma rules strengthen efforts in tackling drug shortages

Some main features of the long-awaited reform of the EU’s pharmaceutical rules address the risks of drug shortages by making the industry more responsible for the security of supply and granting the EU medicine agency an increased coordination role.