Bulgaria Anticipates Growth in Drug Production from EU Pharmaceutical Legislation
Revised EU pharmaceutical regulations are projected to spur production facilities in Central and Eastern Europe, focusing on equitable access and distribution.
The European Union's revised pharmaceutical sector legislation is anticipated to open new opportunities for production facilities in Central and Eastern European countries.
A position paper from Bulgaria, exclusively shared with Euractiv, outlines Sofia's primary goals during the ongoing negotiations.
Bulgaria aims to secure equal access to innovative therapies, ensuring that they remain affordable within the constraints of the country's limited state budget.
A Bulgarian government representative stated, 'Support for the pharmaceutical industry should align with the principle of equal geographical distribution, considering benefits such as the production of generic medicines, antibiotics, and vaccines for Central and Eastern Europe.' The Bulgarian Ministry of Health expressed optimism at the European Affairs Council approving Bulgaria's stance during the EU Employment, Social Policy, Health, and Consumer Affairs Council meeting held on December 2-3.
Pharmaceutical companies lead market growth in Bulgaria, with the sector reaching sales of €5.5 billion in 2023, marking a 15% increase from the previous year.
The legacy of strong generic medicine production, dating back to Bulgaria's Soviet era (1944-1989), endures, complemented by growth in innovative nutritional supplements and veterinary medicine.
However, the high added value manufacturing of costly innovative drug therapies remains underdeveloped.
The Bulgarian position emphasizes avoiding EU-level regulatory assumptions that could negatively impact national pricing and reimbursement systems.
The document suggests expectations that upcoming EU presidencies will ensure Member States' access to comprehensive data from all entities involved in distribution, including wholesalers.
Sofia expresses concerns that implementation of certain recommendations from Mario Draghi's report, advocating for EU-level decision-making, may overlook key national factors such as morbidity specifics and GDP variations, as well as disparities in patients' purchasing power.
Bulgaria argues this could hinder the efficient allocation of national health budgets and potentially widen disparities in access to medical services and medicines.
The Bulgarian position highlights a need to recognize national leadership in health policy development within the EU framework, aiming for resolutions to access issues faced by Bulgarian patients regarding innovative therapies and orphan drugs.
Finally, the Bulgarian Association of Research-Based Pharmaceutical Manufacturers (ARPharM) has cautioned that smaller markets like Bulgaria may face challenges if regulatory protection periods for new drugs are shortened.
This could discourage pharmaceutical companies from registering new drugs, impacting availability.
Despite the country's political instability, marked by three government changes within eight months, Bulgaria's official position in the EU pharmaceutical package negotiations remains consistent.
A position paper from Bulgaria, exclusively shared with Euractiv, outlines Sofia's primary goals during the ongoing negotiations.
Bulgaria aims to secure equal access to innovative therapies, ensuring that they remain affordable within the constraints of the country's limited state budget.
A Bulgarian government representative stated, 'Support for the pharmaceutical industry should align with the principle of equal geographical distribution, considering benefits such as the production of generic medicines, antibiotics, and vaccines for Central and Eastern Europe.' The Bulgarian Ministry of Health expressed optimism at the European Affairs Council approving Bulgaria's stance during the EU Employment, Social Policy, Health, and Consumer Affairs Council meeting held on December 2-3.
Pharmaceutical companies lead market growth in Bulgaria, with the sector reaching sales of €5.5 billion in 2023, marking a 15% increase from the previous year.
The legacy of strong generic medicine production, dating back to Bulgaria's Soviet era (1944-1989), endures, complemented by growth in innovative nutritional supplements and veterinary medicine.
However, the high added value manufacturing of costly innovative drug therapies remains underdeveloped.
The Bulgarian position emphasizes avoiding EU-level regulatory assumptions that could negatively impact national pricing and reimbursement systems.
The document suggests expectations that upcoming EU presidencies will ensure Member States' access to comprehensive data from all entities involved in distribution, including wholesalers.
Sofia expresses concerns that implementation of certain recommendations from Mario Draghi's report, advocating for EU-level decision-making, may overlook key national factors such as morbidity specifics and GDP variations, as well as disparities in patients' purchasing power.
Bulgaria argues this could hinder the efficient allocation of national health budgets and potentially widen disparities in access to medical services and medicines.
The Bulgarian position highlights a need to recognize national leadership in health policy development within the EU framework, aiming for resolutions to access issues faced by Bulgarian patients regarding innovative therapies and orphan drugs.
Finally, the Bulgarian Association of Research-Based Pharmaceutical Manufacturers (ARPharM) has cautioned that smaller markets like Bulgaria may face challenges if regulatory protection periods for new drugs are shortened.
This could discourage pharmaceutical companies from registering new drugs, impacting availability.
Despite the country's political instability, marked by three government changes within eight months, Bulgaria's official position in the EU pharmaceutical package negotiations remains consistent.
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