Medicines for Europe began over 20 years ago as the European Generics Medicines Association (EGA) with the goal of representing the emerging generic industry, and later growing to include biosimilar medicines to its portfolio. As the pharmaceutical industry and the healthcare environment within which it operates have evolved, so has our Association.
When the EGA was first launched back in 1993, generic alternatives to branded medicines made up a fraction of the market. As more of these medicines came off-patent, and the benefits and value of generics to both patients and healthcare providers became clearer, so the provision of generic medicines has increased dramatically.
Our members provide the essential medicines that European patients, healthcare professionals and healthcare systems rely on to treat the most acute and chronic diseases ailments covering a wide range of diseases from cardiovascular, to diabetes and cancer. Better access to the most effective therapies means millions more patients are getting better and living longer, while healthcare inequalities are being reduced.
We now supply over 67% of all medicines in Europe, and over the last ten years, generic medicines have increased access to medicines by over 100% in 7 key therapeutic areas. For the treatment of high blood pressure alone, almost 50 million patients are taking generics each day, and 20 million people across Europe are now being treated for diabetes with generics. (See our IMS infographic on the Role of Generic Medicines in Sustaining Healthcare Systems.)
Technological advances and innovation have had a massive impact on the pharmaceutical industry, including the development of new and highly innovative biologic medicines – a medicine whose active substance is produced by or extracted from a biological source. We have responded to this opportunity with biosimilar medicines – medicines that are highly similar to existing biological medicines, without any meaningful difference in terms of efficacy. With more than 10 years of positive patient and treatment experience in the market, the first biosimilar medicine was approved by the EU in 2006, and the use of biosimilar medicines is expected to result in savings of up to €33.4 billion for 8 EU countries up to 2020.
More recently, we have expanded into value added medicines aimed at optimizing, rethinking and reinventing existing medicines based on known molecules, addressing unmet medical needs of patients through improved care delivery systems. Value added medicines deliver relevant additional improvement for patients, healthcare professionals and/or payers. Benefits include improved efficacy, safety and tolerability profile, better adherence, better quality of life, better convenience of use and/or patient preference. As a novel contribution to the prevention of therapeutic escalation, the rationale use of medicines and improving equity, value added medicines are expected to be play a key role in improving efficiencies of Europe’s health care system.
In its ruling of 30 January 2020, the Court of Justice of the European Union (‘CJEU’) has clarified for the first time the criteria governing whether a reverse payment settlement agreement concerning a dispute between the holder of a pharmaceutical patent (‘originator’) and a manufacturer of generic medicines (‘generic’) is contrary to EU competition law. In particular, the Court has provided further guidance on whether and when: (i) originators and generics should be considered as ‘potential competitors’, (ii) a patent…