Ahead of her session on “Manufacturing Excellence” at CPHI Frankfurt (1–3 November), Elisabeth Stampa, President of Medicines for Europe, along with Adrian van den Hoven, Director General of Medicines for Europe, map out the impact of EU supply chain regulation on pharma companies in an exclusive article for Manufacturing Chemist
Open
Inflation across Europe has risen beyond 10%. This increases the manufacturing costs of essential, off patent medicines, which account for 70% of those dispensed in Europe. These medicines treat serious, debilitating conditions such as cancer, diabetes, cardiovascular diseases, and auto-immune conditions.
Inflation is at an all-time high, opening an opportunity for CDMOs to invest in potentially cheaper sustainable alternatives.
The generic drug industry lobby group Medicines for Europe on Tuesday sent an open letter to European Union member states’ energy and health ministers.
For the last decade, off-patent medicines, which represent the 70% of dispensed medicines in the European Union, have been subject to strict price regulation, budget austerity measures, and lowest-price tender rules, causing substantial price erosion and an unsustainable situation for manufacturers. This has been exacerbated by the Covid-19 crisis and the war in Ukraine, which has dramatically increased general inflation (now over 9%), raw material costs (risen by between 50-160%), transportation costs (up to 500%) and energy prices.
Read the full Open Letter to EU energy Ministers
In line with today European Commission’s Guidelines on a European Gas Demand Reduction Plan, Medicines for Europe urges Governments to maintain energy supply to medicines production sites in the event of energy restrictions in Europe.
Today the transitional period for the application of the Supplementary Protection Certificate (SPC) manufacturing waiver ends. The SPC manufacturing waiver will become operational and generic and biosimilar medicines companies will be able to start manufacturing in Europe for export, stockpiling, and day 1 launch in Europe.
Health systems face tremendous challenges across Europe. The management of COVID-19, war in Ukraine and high inflation rates are challenging supply chains for the most essential medicines.
Off patent medicines account for 70% of those dispensed in Europe, treating severe conditions such as cancer, auto-immune conditions, respiratory diseases, and cardiovascular disease. These medicines are clearly part of the solution for resilient health systems.
Generic and biosimilar medicines lower healthcare treatment costs dramatically and are essential for enabling access to medicines. The EU has therefore made the prompt launch of generic and biosimilar medicines a high priority objective of the Pharmaceutical Strategy for Europe. The 2022 Medicines for Europe Legal Affairs
Conference debated the much-needed reforms to ensure timely access to medicines.