Health experts challenge inequitable distribution of new medicines across EU

As the EU seeks to ensure that patients across all its countries have access to modern, affordable medicines in sufficient quantities, experts warn that the current system is financially unsustainable and call for a change.

“We have a problem at the end of the chain. I believe only industry can solve the pricing issue,” Czech Deputy Minister of Health Jakub Dvořáček told industry representatives in Brussels September 30.

The minister emphasised that the pricing and reimbursement of medicines by insurance companies must be fixed, in order to create a more financially sustainable system.

The EU’s research and development sector for innovative drugs is roughly half the size of  that of the United States – a share which is likely to fall in coming years.

In 2020, the Commission outlined its Pharmaceutical Strategy for Europe, designed to create common rules for the upcoming decades in order to avoid drug shortages and simplify regulation, alongside foster innovation in the EU pharmaceutical sector and finance the industry.

The sector for drug development currently relies largely on a system of patents and other incentives. However, while speaking at the conference, Czech leftist MEP Kateřina Konečná advocated for changing the incentive system and tightening the rules for obtaining patents.

“I would welcome the conditionality of obtaining intellectual property rights, which would increase the availability of medicines. A system where companies have to meet certain conditions to retain rights and access public funding is the right one,” she said.

Anthony Rodiadis from the European Commission’s health service DG SANTE envisaged that the new rules would be predictable, practical and fair. The proposal details are not public, but the Commission should clarify its content in spring 2023.

Commission: Pharma companies need incentives to develop orphan drugs

The market will not regulate itself when it comes to finding solutions to rare diseases, said Sandra Gallina, director at the European Commission’s DG SANTE, adding there is pressure to kickstart innovation on orphan drugs.

No more second-class patients

There are wide discrepancies in the availability of medicines across the EU’s member states. In Germany, for example, 91% of existing innovative drugs are currently available. However, in Slovakia, it is only 3%. The Czech Republic performs on average at 44%.

“This creates inequalities among EU citizens and problems with drug shortages. Citizens of smaller countries must not be treated as second-class citizens,” MEP Konečná said.

Industry representatives highlighted that while they are already working on their own  affordability initiatives, market-led factors mean that equitable distribution is not always simple.

“We have developed a system that allows a drug to be sold into the country at a price the government can afford. We do this quite often, but the reality of the internal market is that the countries to which we have sold the cheaper medicines do not have access to them anyway, because the medicines end up somewhere else,” Nathalie Moll, director of the European Federation of Pharmaceutical Industries and Associations (EFPIA), said.

She added that it is necessary to agree on common rules while solidarity between richer and poorer countries has to be ensured, as well as addressing the respective ‘fitnesses’ of national health systems.

Irena Storová, Director of the State Institute for Drug Control (SÚKL), which is responsible for the regulation in the Czech Republic, highlighted that problems also lie in slow approval processes at the national level.

“There is a need to increase the capacity of European regulatory networks, expand analytical teams, intensify cooperation with scientists, early contact with manufacturers, and at the same time increase the predictability of EMA [European Medicines Agency] decision-making,” said Storová.

At the panel, experts also highlighted the role of the European Access Portal, which began a pilot operation in April. The new tool gives an overview of how quickly medicines reach patients and at which stages the process meets obstacles.

Pharma CEO: Gap between EU vision and national competencies affects health agenda

Despite an exceptional unity of intent during the pandemic, the revision of the bloc’s pharmaceutical legislation could suffer a bump between the EU’s vision for health and this is still conceived at the national level, according to the CEO of a pharma company.

The power of data

Reforms and large investments should be supported by comprehensive data, the sector stakeholders agree. However, a large portion of such data is protected by patient confidentiality.

A European Health Data Space legislative proposal is set to change how patients, doctors, researchers and policymakers access health data. Moreover, the legislation is expected to save billions in public budgets following advanced digitalisation.

Dvořáček emphasised that there are 27 very different healthcare systems in the EU – different ways of reimbursing medicines, different forms of insurance, and different willingness to pay for new technologies.

“We are now in a situation when a huge amount of legislation is being thrown at us to change that. And each of those proposals is trying to create a more connected system. I believe that the European Health Data Space is a major step towards making that interconnection happen,” the deputy minister said.

The Czech EU Presidency is seeking a compromise at the ministerial level. As EURACTIV.cz understands, the European Health Data Space represents the “main health task” the Czechs have until the end of the year.

Health committee will co-lead health data space dossier in the European Parliament

Despite the initial decision to assign the European Health Data Space exclusively to the European Parliament’s civil liberties committee (LIBE), it has now been agreed that the committee for health (ENVI) will co-lead the file, which expands the EU data regulation.

[Edited by Gerardo Fortuna/Nathalie Weatherald]

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