Pharma industry fears Bulgarian political crisis could hurt negotiations

The Bulgarian pharmaceutical industry fears that the country’s political crisis could negatively impact the protection of national interests during the negotiations on the new European pharmaceutical legislation.

“During the trialogue, 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.

Bulgaria will hold both national and European parliamentary elections on June 9, after Nikolai Denkov’s pro-EU government fell from power in April. In the coming months, the EU’s poorest country will be governed by the caretaker government of GERB-affiliated economist Dimitar Glavchev.

EU Parliament rearrangement

Opinion polls suggest that a major replacement of Bulgaria’s representatives in the European Parliament is imminent. About a third of the current 17 Bulgarian MEPs are likely to get a new mandate, with the pro-Russian far-right party Vazrazhdane (Revival) hoping for four seats in the EP.

“The political crisis will also affect the Bulgarian representation in the European Parliament, which again threatens our position on the Pharma Package. The new people will have to get acquainted with the specifics of the pharmaceutical package very quickly and on the basis of what has been done so far, to form their position, which takes into account the Bulgarian interest,” Denev said.

Hopes for broader access

Bulgaria has high hopes that the new pharmaceutical package will solve some of the chronic problems Bulgarian patients face with access to innovative therapies and orphan drugs.
One of the aims of the proposed European legislation is to ensure that all European citizens have access to as many drug therapies, proven to be effective, as possible. Currently, Bulgarian patients have access to only 45% of new therapies for cancer, while in Germany, they have access to 90% of authorised therapies.

“The pharmaceutical legislation is trying to create a mechanism to approximate access because it is not right that a Bulgarian patient should have to go to Germany to receive treatment. We have many such cases,” Deyan Denev says.

Pharma package’s contentious aspects 

At the same time, some of the European Commission’s key proposals are not supported by the pharmaceutical industry in many European countries, including Bulgaria.

The Commission is trying to motivate innovative pharmaceutical companies to launch their new medicines simultaneously across the EU. If companies do not launch new therapies and medicines in all Member States within the first two years of authorisation, the EC proposes to shorten data protection by 2 years. If the medicines are launched, companies will restore this protection.

The Bulgarian pharmaceutical industry has criticised this EC proposal because it introduces a large degree of uncertainty to research investment in Europe. Authorisations for the use of new therapies are in the hands of the Member States and do not depend on pharmaceutical companies.

Regulatory Data Protection

Bulgaria already expressed its position that the proposed EU data protection mechanism will not work well. The previous Bulgarian government claims that adding conditional extra data protection periods for new drug therapies as incentives for manufacturers to bring new drugs to market leads to “unpredictability”.

“This proposal is simultaneously related to both unpredictability for the industry and pressure on each member state to plan and determine its needs in advance, with a high degree of uncertainty,” the government said in January.

Currently, the pharmaceutical industry has the opportunity to match the entry of medicinal products into the various markets with the specific needs and resources of each country. This is determined after negotiations with national institutions.

Bulgarian authorities are concerned that the new rules will make access to innovative medicines even more difficult for Bulgarians. Currently, pharmaceutical companies avoid exporting rare drugs to the small Bulgarian market.

Budget restrictions

Bulgaria’s most serious challenge is to ensure acceptable prices for new therapies. The current budget of the state health fund (€ 4 billion per year) does not provide much scope for financing all innovative therapies.

The Bulgarian Ministry of Economy provided its two framework positions on the directive and regulation proposals back in January, but the situation in Sofia is now different, which may change the Bulgarian positions.

The caretaker government is expected to be in power until at least mid-July, after which a new regular government could be appointed if a ruling majority is formed in Parliament.

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

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