Focus on national competence and drug prices in EU pharma package, says Bulgaria

Bulgaria’s updated position paper on the revision of the EU’s pharmaceutical legislation underlines the importance of national competence and focuses on access to new medicines for citizens of poorer countries.

According to the document seen by Euractiv, Sofia opposes granting the European Commission additional powers that would affect national authorities’ ability to determine the country’s drug policy independently.

“In order to avoid unclear interpretation on this matter, clear definitions of the texts in the Directive are necessary,” the Bulgarian position says.

The position of the institutions in Sofia regarding the pharmaceutical package is almost entirely centred around fears of increased costs due to future EU legislation.

The Bulgarian government emphasises that “(…) it is important to take into account the specifics of the individual EU member states, including their different financial capabilities, and to preserve the possibility of an independent dialogue between the industry and the national competent authorities while respecting the exclusive national competence in the sense of the Treaty on the functioning of EU.”

Ensuring access

One of Sofia’s main demands is to create an opportunity for countries with a lower GDP to pay lower prices for new medicines in order to facilitate access for Bulgarian citizens.

Bulgaria’s other major concern comes from the conditions proposed by the Commission concerning the regulatory protection of new drugs. The Bulgarian government fears that creating data protection uncertainty for pharmaceutical companies could also raise prices.

Another concern stems from the Directive proposal to extend the regulatory data protection by six months for a drug intended to address an “unmet medical need” (UMN).

Unclear definition of UMN

Sofia’s criticism is that the legislative proposal does not provide a clear definition that objectively regulates and formulates the concept of “unmet medical needs”.

UMN can manifest itself in different ways, depending on the specific epidemiological situation in the member state, Bulgaria claims.

The preamble to the proposal for the directive foresees that this matter will be further clarified, taking into account the scientific input of EMA. However, the Bulgarian government insists that this issue be resolved with the adoption of the final texts of the pharma package. Again, the concern is that any uncertainty could lead to higher prices for innovative drugs.

“In order to achieve predictability for the developers of innovative therapies, as well as clarity and the absence of subjectivity in the assessment by a competent authority, it is necessary to make efforts, during the negotiations, to derive a definition that objectively and unambiguously defines the concept of UMN,” Bulgaria states.

The Bolar exception

At the same time, the country supports the concept of providing regulatory data protection to the so-called repurposed medicinal products when developing a new therapeutic indication that was not authorised in the EU territory and has a significant clinical contribution.

Bulgaria has requested an explanation from the Commission regarding the practical application of some provisions related to data protection for generic products. It insists that the scope of the Bolar exception be extended as much as possible.

The Bulgarian position “believes that the proposal to extend the Bolar clause will facilitate the timely market entry of generic, biosimilar, hybrid and biohybrid medicinal therapies, which in turn will increase the sustainability and solvency of the healthcare system,”

Institutions in Sofia support the provisions relating to the incentives provided for medicines for paediatric use.

The Bulgarian pharmaceutical industry supports the positions expressed so far on the pharma package by the institutions in Sofia, but there are fears that the political crisis may have a highly negative effect.

“During the trilogue, a final EU position is being sought, and Bulgaria’s participation is extremely important. With a new government, the new negotiating teams will need time to explore the previous positions. It will be a big challenge for Bulgaria to participate actively,” Deyan Denev, the executive director of the Association of Research-based Pharmaceutical Manufacturers in Bulgaria (ARPharM-Bulgaria), told Euractiv.

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

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