Poland leans towards shorter data exclusivity period, one year market protection [Advocacy Lab Content]

Warsaw has sided with the European Commission on the length of the Regulatory Data Protection (RDP) period in the EU Pharma Package. Poland advocates that the incentives scheme should focus on market protection and not last more than a year.

Poland was vocal on its position at the recent meeting of the Employment, Social Policy, Health, and Consumer Affairs Council of the European Union in Luxembourg, Health Minister, Izabela Leszczyna’s statement on the country’s expectations regarding the pharmaceutical package prompted responses from both the Polish generic and innovative pharmaceutical sectors.

“In the ongoing discussion about reforming EU pharmaceutical law, it is crucial to consider drug safety and sector development not only at a national level but across Europe,” Michał Byliniak, General Director of INFARMA, told Euractiv. “This is essential for advancing innovative therapies and maintaining Europe’s global competitiveness.”

In favour of a shorter RDP

Addressing the specifics of the pharmaceutical regulations, Minister Leszczyna expressed Poland’s support of the Commission’s proposal of a shorter RDP period.

“In April 2023, the European Commission presented a package of amendments to revise pharmaceutical legislation concerning medicinal products, proposing to shorten the data exclusivity period for drugs from eight to six years. We support this,” she said.

Minister Leszczyna explained that this approach aims to streamline access to modern therapies without increasing administrative burdens. She suggested considering an extension of this period with potential incentives under a market protection framework.

“We also support granting one year of market protection instead of one year of data protection for new therapeutic indications,” the minister noted. She expressed concerns that the proposed eleven-year limit for data and market protection could excessively delay the entry of generic drugs to the market.

Conditional incentives

Leszczyna emphasised Poland’s principal support for introducing mechanisms that meet the access needs of all EU member states to modern therapies.

“This is a key message and a primary goal of the revision. We are open to an incentive system, provided it does not exceed twelve months and focuses on market protection rather than data protection. We are also willing to discuss the extent to which incentives are tied to reimbursement procedures,” she remarked.

Simultaneously, she indicated that extending additional protection periods should only be justified for drugs treating rare diseases. “For other medicinal products outside orphan drugs, we propose exploring alternative solutions,” Leszczyna said.

Leszczynar also affirmed Poland’s commitment to establishing a more efficient regulatory system ensuring timely and equitable access to safe, effective, and affordable medicines.

Increased production needed to avoid shortages

“It’s important to remember that drug shortages primarily affect generics, which are crucial for millions of patients,” explained Krzysztof Kopeć, President of the Polish Association of Pharmaceutical Industry Employers – National Drug Producers, to Euractiv. “One of the main reasons for these shortages is the declining profitability of their production in Europe.”

Kopeć pointed out that while the European Commission aims to reintroduce medicine and component production to Europe, it has yet to propose regulations supporting this objective. He stressed that manufacturing costs in Europe are consistently higher than in Asia. “For the safety of Poles, the most critical aspect would be producing essential medicines vital for health and life,” he emphasised.

The European Union has compiled a list of such indispensable medicines, without which patients could face severe health consequences or even death. Currently, only a few active substances from the list of over 200 critical medicines are produced in Poland. “This situation does not provide confidence. We need to increase production,” Kopeć added.

Risking access to innovation

According to innovative pharmaceutical companies, resolving drug access issues should not involve altering existing intellectual property rights protections and legal frameworks in the EU. They argue that the legal framework should continue to support innovation and ensure EU patients have access to cutting-edge healthcare and medicines.

“Considering the objectives of pharmaceutical reform, it should equally address solutions to enhance drug supply security, availability, and affordability while supporting innovation and industry development in new drug sectors,” Byliniak stated.

INFARMA is engaged in ongoing discussions with the Ministry of Health and all stakeholders, highlighting potential risks associated with reducing legal protection periods for drug safety in the EU and Poland. They also raise concerns about the potential repercussions of limiting patient access to advanced therapies.

They advocate maintaining current data protection levels without conditional ties that do not address the fundamental reasons behind disparities in patient access to medicines across the EU. Additionally, INFARMA calls for establishing an incentive system to promote innovation, address unmet medical needs, and encourage research within the EU.

[By Paulina Mozolewska, Edited by Vasiliki Angouridi, Brian Maguire | Euractiv’s Advocacy Lab]

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