Bulgaria’s health ministry is voicing concerns over the EU’s proposed pharma package, warning that it could undermine national medicines policies and drive up prices.
Sofia argues that the legislative overhaul, intended to boost innovation and improve access across the Union, risks imposing uniform rules that disregard local conditions and could force smaller markets such as Bulgaria to pay prices similar to those in wealthier countries.
The health ministry told Euractiv that Sofia finds it unacceptable for the new legislation to dismantle functioning national mechanisms. The major concern is that if part of the sector’s control is centralised in Brussels, Bulgaria could be forced to purchase medicines at the same prices as wealthier EU states.
“It would be unacceptable to reach compromise solutions that limit this freedom of judgement, dismantle effective national solutions and methodologies, break the link between needs and the medicines budget, or lead to convergence of prices,” the health ministry said.
Industry seeks stability
The Bulgarian government has declined to forecast whether negotiations with the European Parliament will be concluded during the Danish presidency.
While the government’s main focus in the talks is on medicine prices and control over medicines policy, the Bulgarian pharmaceutical industry is prioritising better market access.
With a population of 6.4 million, Bulgaria represents a relatively small market for large pharmaceutical companies, which creates problems for Bulgarian patients’ access to innovative therapies. The authorities’ efforts to purchase medicines at the lowest possible prices also do little to improve access.
Deyan Denev, executive director of ARPharM-Bulgaria, told Euractiv, “For Bulgaria, the most important goal is to achieve a balance between patient access to medicines and encouraging innovation in the industry.” He added that in its positions on the pharma package, Bulgaria has emphasised that the predictability and stability of the regime are essential for the industry and its member states.
Trilogue negotiations
Denev noted that many contentious issues remain for the Danish presidency to address and negotiate, not least, the “speeding up [of] authorisation procedures for medicines, managing shortages and supply security, labelling, electronic leaflets and digitalisation,” said Denev.
However, he emphasised that the main dispute continues to be over the periods of regulatory data protection and market protection for innovative medicines.
“The compromise proposed by the Council during the Polish presidency is considered an improvement on the Commission’s initial proposal, which envisaged reducing the basic protection from eight to six years and linking additional protection to vague conditions beyond the control of manufacturers. That is why the current legislation is seen as the most stable framework,” Denev explained.
He added that the industry continues to insist on retaining the eight-year baseline for data protection and warned against excessive modulation and conditions that increase uncertainty and administrative burden.
“This will reduce the EU’s competitiveness and worsen patients’ access to modern therapies,” Denev said.
(VA, BM)
