Poland’s pharmaceutical industry says there’s still a long journey ahead for the revision of the EU’s pharmaceutical legislation. Despite the Pharma Package now heading to Council, the Polish Ministry of Health chooses to remain silent.

On 10 April the European Parliament formally endorsed its position on the first reform of European pharmaceutical legislation in 20 years. The compromise represents the culmination of an intense and protracted debate aimed at enhancing the accessibility and affordability of medications.

“Despite the amendments introduced in the European Parliament, the pharmaceutical legislation still has a long journey ahead to restore Europe’s competitive edge,” Michał Byliniak, Director-General of The Employers’ Union of Innovative Pharmaceutical Companies INFARMA, told Euractiv.

Declining competitiveness of Europe

One of the biggest challenges noted by the pharmaceutical industry is that this reform must address the declining competitiveness of Europe. Currently, only one in five new treatment methods are being researched and developed in Europe, compared to nearly 50% at the end of the last century.

According to Byliniak, this situation is not alleviated by decisions to shorten the period of regulatory data protection by six months.

“This remains a challenging proposal to accept because reducing incentives for research, development, and production of new drugs and vaccines is not in the best interest of Europe and its patients, particularly at a time when Europe needs to compete for global investments with ambitious countries like the USA and China,” he told Euractiv.

Byliniak views it as a positive step that Members of the European Parliament have acknowledged the unreasonableness of tying the two-year regulatory data protection (RDP) period to the availability of new medicine in all 27 EU member states within two years of receiving marketing authorisation.

“We must bear in mind that the majority of factors affecting medicine accessibility are beyond the purview of individual companies,” he stated.

Long journey ahead

After the vote in the European Parliament, the legislation will now proceed to the Council for further deliberation. One of the crucial steps will be the definition of unmet medical needs.

Although there has been considerable controversy surrounding the restrictive definition of unmet medical needs, Byliniak acknowledges that, under the proposals put forth by the European Parliament, all stakeholders will have the opportunity to participate actively in identifying unmet medical needs from diverse viewpoints.

Other crucial areas include issues such as drug shortages, manufacturing, environmental protection, and vaccines.

As Byliniak points out, the adopted regulations do not fully account for the specificity of vaccines, especially regarding the obligation to undergo pricing and reimbursement procedures.

In his opinion, this could lead to suboptimal and unequal access to vaccinations, thus resulting in insufficient protection for the European population. “We are, however, reassured by the fact that the adopted definition of a vaccine is currently aligned with the EMA guidelines for vaccine assessment and allows for future innovations in this field,” Byliniak added.

The voice from the other side

A completely different perspective is presented by Grzegorz Rychwalski, National Drug Manufacturers deputy head, who is urging that the total regulatory exclusivity be limited to 11 years in the next stage of the legislative process. It would still represent the longest protection period worldwide.

“It will be crucial to support the harmonised Bolar amendment to prevent delays in introducing competition in the EU pharmaceutical market, which ultimately enhances therapy accessibility,” Rychwalski told Euractiv.

According to Rychwalski, it is also imperative to accelerate the European Commission’s efforts to introduce mechanisms supporting the production of APIs and basic medicines in the EU, considering the even distribution of this production throughout the Union.

“We also call for the introduction of an accelerated path for regulatory efficiency and digitisation aimed at supporting drug accessibility and ensuring effective risk assessments for the environment based on data references,” he added.

Regardless of their differences, both innovative and generic Polish pharmaceutical sectors recognise the opportunities and risks presented by the amendments introduced in the European Parliament.

They also share a hopeful outlook, believing that collaboration with various stakeholders can lead to practical solutions to improve patient outcomes in Europe.

The Polish government’s perspective will be significant, particularly since the final vote on the package will likely occur during Poland’s presidency. However, when asked for comment, the Polish Ministry of Health did not clarify its position to Euractiv.

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

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