21st EGA Annual Conference. Generics and Biosimilar Medicines: 2020 Vision (event review)

by María Victoria Rivas Llanos

The European Generic Medicines Association (EGA) celebrated its 21st annual conference last 10-11 June 2015 in Berlin, Germany. The main theme of this year’s conference was “Generics and Biosimilar Medicines: 2020 Vision”.

The event offered a broad variety of “hot topics” in the industry of generic and biosimilar medicines, presented by renowned experts in the field. The issues discussed were as follows:

Wednesday 10 June

Generic and Biosimilar Medicines for All Patients

Nick Haggar (EGA President & Sandoz Head WEMEA) opened the event with an introduction to EGA’s five pillars (patients, quality, value, sustainability and partnership) and introduced a panel discussion chaired by Frank Bongers (Bogin). The panel was formed by Mr. Haggar, Alan Sheppard (IMS Health), Martin Albrecht (IGES Institut GmbH), Nicola Bedlington (European Patients’ Forum) and Martin Seychell (DG SANTE European Commission).

The group of experts debated over the importance of generic competition for the maintenance of financial sustainability of health systems, considering the added value of generic medicines not only in terms of costs saving but also in relation to patients-related value and patients’ access to generic medicines. The panel presented some challenges faced by the generic industry in meeting this target, such as an ageing population in need for more healthcare services while the flat economic growth is forcing continued austerity measures, pharmaceutical spending’s tendency to follow the GDP growth rather than population needs and off-patent’s low penetration opportunities in major markets.

Moving Towards an Efficient Regulatory System

The next session was divided into two topics, between which participants were offered the possibility to choose. These topics were: “Stakeholder contribution to a healthy ageing society” and “Moving towards an efficient regulatory system”. The latter was chaired by Warwick Smith (BGMA) and presented by Peter Bachmann (CMDh), Hugo Hurts (CBG MEB), Peter Richardson (EMA) and Beata Stepniewska (EGA). The group discussed the key elements in the regulatory system that will bring added value as a key for efficiency, i.e. the impact on access to medicines, maintenance and life cycle management, and globalisation. This could be achieved, as the group proposed, through closer collaboration between the generic industry and national competent authorities, a single development programme for biosimilar and generic medicines, information sharing and regulatory convergence in an international context.

Corporate Responsibilities and the Opportunity to Save Lives

Anthony Dunnett (President of International Health Partners) made a presentation on the European Medicines Donations initiative (EURMED). EURMED was founded in 2014 by three European medical NGOs (Action Medeor, IHP and Banco Farmaceutico) as a new initiative that enables the donation of medicines from European healthcare industry to NGOs for disaster relief and humanitarian aid. Through its online donation tool, EURMED provides a system for needs-based allocation of donated products and ensures secure and effective delivery of medicines by tracking products to their final destination.

Health Equality and Sustainable Access to Medicines

Once again the session was bifurcated into two eligible areas: “Health equity and sustainable access to medicines” and “Taking advantage of trade opportunities”.

The former was chaired by György Thaler (Richter Group) and presented by Nicola Magrini (WHO), Zoltán Kaló (University Budapest), Peggy Maguire (European Public Health Alliance) and Elke Grooten (at Sandoz).

Mr. Magrini focused on the World Health Organisation’s Essential Medicines List and its implications for generics and biosimilars. Peggy Maguire talked about the European Commission’s project “Horizon 2020” and its impact on the pharmaceutical industry in terms of open access, patent pooling and responsible licensing. Professor Kaló concentrated on the investment aspects of off-patent medicines. Finally Mr. Grooten presented generic and biosimilar medicines as key contributors to health equality and sustainable access to medicines.

Value Added Medicines: Key Driver towards Healthcare Efficiency

David Morgan (OECD), Ewald Kreid (Boston Consulting Group), Elena Klimova (IMS Health) and Sampreet Ramachandra (Fresenius Kabi) advised on how to tackle the problem in the current healthcare system of high healthcare spending with low value outcomes through technical, allocative and dynamic efficiency strategies; the potential of the third sector of pharmaceuticals (between new chemical entities and generics) particularly in relation to primary care, specialty therapy classes and chronic therapeutics areas; and the importance of continuous innovation in off-patent medicines not to reduce them to commodities.

Ethic Workshop: EGA Code of Conduct

The last theme of the day was presented by EGA’s Director General, Adrian van den Hoven, and debated by a panel of five experts, i.e. Frank Bongers (BOGIN), Nicola Bedlington (European Patients’ Forum), Christophe Lesguer (Mylan), John Chave (PGEU) and Birgit Beger (Standing Committee of European Doctors). They talked about EGA’s Board Mandate of March 2014 on transparency and share of expertise with the Healthcare Community, as well as the proposal for generic and biosimilar disclosure schemes to be approved by the EGA’s Board in December 2015. In addition, Ms. Beger presented the Standing Committee of European Doctors (CPME) Guidelines on the transparency of relationships between physicians and the healthcare industry.

Thursday 11 June

Joining Forces in the Fight against Counterfeit Medicines

The second day was opened by two simultaneous sessions with different focuses: “Joining forces in the fight against counterfeit medicines” and “How are generic and biosimilar medicines perceived”. The former was expounded by John Chave (PGEU), Martin Fitzgerald (GIRP), Maarten Van Baelen (EGA), Richard Freudenberg (EAEPC) and Richard Bergström (EFPIA). The group of expert deliberated on the Falsified Medicines Directive’s pan-European measures on safety and controlled trade of medicines, as well as the essential role played by the European Medicines Verification Organisation (EMVO) in the protection of patients from counterfeit medicines. They further explained the requirements for achieving a completed European medicines verification system by 2018 both at the EU and national level.

Biosimilar Medicines Market Trends

Subsequently, attendants could choose again between two options: “Biosimilar medicines market trends” and “Entrepreneurial visions of the future of our industry”.

Simon Goeller (McKinsey & Company), David A. Dunn (Thomson Reuters) and Isabell Remus (Sandoz) advised on current market trends in the area of biosimilar medicines and some strategies on how to maximise the chances of market success by creating demand through a holistic view that takes multiple stakeholders into consideration.

The Trends Reshaping Business

Laurent Haug (New Technologies Investor at Anthemis and MKS AI) noted the huge impact of the Internet in certain areas of the “Industry 4.0” and the high potential of data for businesses, particularly when the data is connected to objects, e.g. smart machines and 3D printing. For this reason, Haug argued that transparency and information sharing are essential for the development of technology. The Internet and data inevitably form part of today’s technological advancement, around which companies should adapt their strategies in order to guarantee market success. As Mr. Haug concluded his enlightening speech: “change is an opportunity if you anticipate it, it is a threat if you don’t”.

Generic and Biosimilars: 2020 Vision

The conference ended with an overview on how to maintain EGA’s five pillars in the ever-changing environment of the pharmaceutical industry. This topic was discussed in a panel formed by Nick Haggar, Jacek Glinka (Mylan), Marc Alexander Mahl (Fresenius Kabi), Christoph Stoller (Teva) and Frank Große-Natrop (Phoenix).