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Pharmaceutical legislation reforms must support equitable access to medicine in Central and Eastern Europe and security of medicines supplies


17 Nov 2022


Health & Consumers

Date of release: 16 November 2022

Brussels, Belgium

Equitable access to medicines is a challenge across Europe. Access to therapies used to treat major chronic diseases remains particularly limited in Central and Eastern Europe (CEE). Off patent medicines are often the first opportunity for patients to access the essential medicines they need.  

Across Europe, skyrocketing inflation (+ 9%) and steep rises in the price of energy, raw materials (+50-160%) and transportation (up to 500%) are massively increasing costs for manufacturers. At the same time, rigid pricing policies force down the price of essential medicines to unsustainable levels, threatening their availability. 

The Czech Presidency of the European Union, due to the COVID-19 pandemic and Russian aggression in Ukraine, considers medicines manufacturing to be one of the areas where existing vulnerabilities need to be understood in detail and resilience must consequently be strengthened.  

Medicines for Europe and ČAFF call for the following EU and national reforms that could support this ambitious agenda:  

·       Develop policies to encourage generic and biosimilar medicines use, which will broaden patient access 

·       Tackle the impact of inflation on the security of essential medicine supplies with smart procurement guidelines for medicine 

·       Allow the off-patent medicines industry access to EU funds for manufacturing investments and optimise the regulatory system to improve access to medicine and to benefit from digitalisation efficiency gains. 

At an event held under the patronage of the Czech Presidency of the EU, Medicines for Europe’s President Elisabeth Stampa commented: “EU policies can do more to encourage the uptake of generic, biosimilar and value added medicines, which have demonstrated their massive contribution to improving access in Central and Eastern Europe. The EU must also tackle the huge threat that inflation poses for medicine manufacturing and supply. Our industry needs market adjustments to cover the cost of inflation or medicines supply will be at risk.”

Chief Executive Officer at CAFF, Filip Vrubel commented “There is enormous pressure from European countries to keep the price of medicines as low as possible. Reform of the European pharmaceutical legislation must start to alleviate this pressure where price erosion has driven the price of medicines to the bottom and the market is no longer competitive. Public support for the expansion of production capacity in the EU should also be considered, with EU-made medicines being rewarded in tenders and long-term pricing agreements prioritising competitiveness and sustainability in the market and stability of supply.

Deputy Minister of Industry and Trade of the Czech Republic, Marian Piecha, commented “Building resilience in such a complex industry means we need to ensure full production process at any circumstances. When thinking about pharmaceutical production, I suggest we start thinking out of the box. We have to support technological process innovation for a competitive industry which leads to sustainable production.

Resource hub & references

§     The joint EFCG-Medicines for Europe paper on active pharmaceutical ingredients can be accessed here

§     For data on inequities in access to medicines in the region, Medicines for Europe’s report, entitled “Removing access barriers in Central and Eastern Europe: How can we ensure equitable access to medicines for all European patients?” is available here   

§     A dedicated podcast on access issues in the CEE region is available here  

About Medicines for Europe

Medicines for Europe represents the generic, biosimilar and value-added medicines industries across Europe. Its vision is to provide sustainable access to high quality medicines, based on 5 important pillars: patients, quality, value, sustainability and partnership. Its members directly employ 190,000 people at over 400 manufacturing and 126 R&D sites in Europe and invest up to 17% of their turnover in R&D investment. Medicines for Europe member companies across Europe are both increasing access to medicines and driving improved health outcomes. They play a key role in creating sustainable European healthcare systems by continuing to provide high quality, effective generic medicines, whilst also innovating to create new biosimilar medicines and bringing to market value added medicines, which deliver better health outcomes, greater efficiency and/or improved safety in the hospital setting for patients. For more information visit and follow us on Twitter @medicinesforEU. 

About Česká asociace farmaceutických firem (ČAFF)

The Czech Association of Pharmaceutical Companies brings together the main manufacturers and suppliers of generic and biosimilar medicines in the Czech Republic, including domestic medicine manufacturers. It represents the pharmaceutical industry in our country and supports its social status and development. We are a member of the European association of pharmaceutical companies, Medicines for Europe, which represents companies in our field from all over Europe. Thanks to this, we ensure the connection of the Czech Republic to the European pharmaceutical industry, European legislation and medicines regulation. ČAFF member companies employ more than 4,400 people and deliver about 75 million packages of medicine to the Czech market annually, worth just under €13 billion. 


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