Brussels, 24 January 2022

The ongoing review of the EU pharmaceutical legislation framework is a major opportunity to update the EU regulatory system. Future reforms should focus on a system that delivers meaningful benefits to patients, particularly timely access to medicines supported by efficient regulatory processes, readily accessible information on medicines and better systems to manage medicines shortages.   

The off-patent medicines sector accounts for almost 70% of medicines dispensed in Europe, helping to manage the most prevalent chronic diseases including cancer, auto-immune conditions, cardiac disease and diabetes. The regulatory framework must be tailored so that these medicines can readily get to the patients and healthcare professionals who need them. 

The upcoming review of the EU pharma legislation should prioritise the following regulatory initiatives: 

• A strong push for European-wide digitalisation, including the creation of an interoperable digital network of medicine agencies. This is essential to enable the quick exchange of regulatory data between medicines agencies and, where relevant, with industry. 
• Simplify and streamline procedures, reducing regulatory burden and costs 
• Prevent the unnecessary and unethical repetition of clinical studies for off-patent medicines by integrating scientific progress, supporting single development, and leveraging international regulatory convergence and cooperation. 

Speaking at the Medicines for Europe regulatory affairs conference, ad interim President Rebecca Guntern said: “It’s almost impossible to exaggerate the extent to which access to affordable off-patent medicines depends on a fit-for-purpose and fully-digitalised regulatory framework. The proper functioning of this system is absolutely critical, both to get the right medicine to the right patient at the right time today and to ensure the sustainable development of the industry to meet the patient needs of tomorrow.”

The series of regulatory affairs webinars will take place between January 24th and 09th February. For more details, and to register, please visit https://www.medicinesforeurope.com/events/racphv2022/  

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 please follow us at www.medicinesforeurope.com and on Twitter @medicinesforEU. 

Medicines for Europe Communications:

Kate O Regan koregan@medicinesforeurope.com