Health Council to grapple with incentives in pharma package

Ministers gathering in Luxembourg on Friday (21 June) for the final Health Council of the Belgian European Council Presidency will grapple with one of the thorniest issues of the pharmaceutical package, that of incentives.

Striking a balance between incentivising innovation and improving access to medicines has been one of the central issues in the debate on the future pharma package with stakeholders having a significant divergence in views.

Medicines for Europe, which represents the generic, biosimilar and value-added medicines industry, argues that ministers should “prioritise equitable access for all patients.”

This, they argue, should be done by “breaking down all artificial barriers to fast and timely access to generic and biosimilar medicines” and “supporting the Commission proposal for modulation of incentives while capping the total regulatory protection to 11 years,” and “modulating market protection rather than data protection to ensure that the off-patent alternative can be approved in time to supply markets not served by the originator manufacturer.”

However, the European Federation of Pharmaceutical Industries Association (EFPIA) has argued: “Europe has lost ground as a location for R&D investment to the US and China in the last 20 years. This trend has to be reversed and aligned with the European Council Conclusions of March 2023 according to which Europe should look to strengthen, not to weaken incentives for medical innovation.”

Like industry, health ministries across Europe are also divided. Countries with strong pharma sectors, such as Sweden, tend to align more closely with EFPIA’s views, those anxious to reduce cost and improve accessto new medicines, such as Czechia, are closer to the European Commission’s position. 

The Belgian Presidency has proposed taking a step back from setting protection periods to focus on the design and purpose of the incentives. Nevertheless, they have proposed setting an overall eleven-year cap on protection. 

The package allows for extensions to data and/or market protection under a number of circumstances, including when it is a medicine that tackles a currently unmet medical need, if a medicine is launched in all EU countries, if a significant part of its development takes place within the EU, or where an additional therapeutic property is identified providing significant clinical benefits. 

Where an additional therapeutic benefit is found, the presidency proposes that an extra year of market protection be offered rather than an extra year of regulatory data protection. This would allow generic companies more time to prepare for market entry. 

The presidency will also propose that medicines that meet unmet needs should be granted nine years of protection and an additional year if they meet a high unmet need. 

To ensure transparency, the presidency proposes that a public register should be developed, so that data and market protection periods are clear. 

Access for all

The other question that will be asked at today’s council is how to make sure that all EU states can access innovative medicines. Four possible solutions are proposed by the Belgian presidency, following discussions in working groups.

The first three options examine how this can be achieve via incentives, while the fourth option looks at the possibility of making access an obligation on companies to make real efforts to supply all EU states.

Unmet needs

The final question that will be addressed on the pharma package will be determining unmet needs. The presidency proposes that the criteria go beyond the purely medicinal and include treatments and diagnosis.

It is proposed that the European Medicines Agency (EMA) prepare guidelines involving stakeholders to objectively assess what amounts to an unmet need. 

The Council is only at the beginning of its discussions.

In the meantime, the European Parliament has already adopted its position at first reading.

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