Bulgaria’s passive pharma negotiating position slammed by MEP

Sofia: Bulgaria has been criticised for its passive approach to the EU Pharma Package, despite the topic’s importance for local industry and Bulgarian citizens’ well-being.

MEP Radan Kanev (Democrats for Strong Bulgaria, EPP) told Euractiv that while the EU Pharmaceutical Package is considered critically important for the Bulgarian economy and healthcare system, Bulgaria is experiencing serious problems related to the distribution of public resources and the slow introduction of modern drug therapies.

Radan Kanev, noting the limited Bulgarian political discussion on the new pharmaceutical legislation, told Euractiv that closed-door debates had revealed contradictions between the different investors in the Bulgarian pharmaceutical industry.

“We have had contacts with some industrial groups in Bulgaria. The positions did not seem to be entirely clear because we have a large-scale production of generics but also a considerable innovative industry. The interests of these two groups clashed over the Pharma Package,” said Kanev.

Bulgaria developed its overall position on the new EU pharmaceutical legislation during a period of serious political instability. This position was developed during the term of the government led by Prime Minister Nikolai Denkov, who resigned at the end of March 2024.

The country was then governed by a caretaker administration led by Prime Minister Dimitar Glavchev, a former MP from the largest Bulgarian party – GERB (EPP).

In January, a regular government was elected in Sofia, with Prime Minister Rosen Zhelyazkov (GERB) supported by a fragile four-party coalition.

During this period, the EU Pharma Package seemed to be of least concern to the Bulgarian authorities. However, the Glavchev government expressed hope that the European reform would lead to greater investment in the production of medicines in the country.

Kanev hopes that following the election of a regular government, the Bulgarian position will be activated.

“Whenever a stable government is elected, there is greater hope of consolidating the Bulgarian position so that when the compromises at the COREPER level begin, we can orient ourselves more clearly,” remarked Kanev.

He told Euractiv that, as a substitute member of the European Parliament’s Public Health and Industry committees, he would encourage a more active Bulgarian position on the topic this year.

In a statement to Euractiv, the Bulgarian branch of ARPharM warned that a small drug market like Bulgaria could seriously suffer from reducing the regulatory protection period for new drugs. This could lead to a lack of interest in pharmaceutical companies registering new drugs.

National statistics show that the country’s pharmaceutical sector generates over 2% of GDP (€2 billion), which aligns with the European average. Almost 28,000 people are directly employed in the sector, and salaries are twice the national average.

The Bulgarian branch of ARPharM criticises the European Commission’s proposal to reduce the drug patent period for new medicines from eight to six years.

The new shorter term would be insufficient to ensure a return on the enormous investments needed to develop new therapies. It would discourage pharmaceutical companies from making such investments in EU countries, including Bulgaria.

Sofia’s position so far has been that the European Commission’s proposed changes to intellectual property law risk limiting incentives for innovative producers and upheavals in the national decision-making process.

At the same time, the Bulgarian authorities are focusing during negotiations on maintaining national control over the approval of new drug therapies.

The poorest country in the EU fears that if most of the regulations are transferred to Brussels, this will lead to an increase in the prices of drug therapies. Because of this, the authorities in Sofia even proposed creating a European mechanism that would force pharmaceutical companies to sell cheaper to countries with smaller GDPs.