by | December 21, 2021 | Reports

Synopsis Report: EPHA’s access to medicines (A2M) dialogues series 2021

EPHA’s access to medicines, A2MDialogues series started in the second half of 2020 with five episodes of an-hour long, live, online conversations with key decision-makers shaping medicines’ policies in Europe. The series continued in 2021 with four additional episodes during the first half of the year.

The #A2MDialogues series aims to expand the conversation and to guarantee a comprehensive, balanced debate on the most timely policy topics. The COVID-19 pandemic has caused a proliferation of virtual events but EPHA’s A2MDialogues managed to attract a regular audience of an average 80-100 participants, tuning in live each time and many more watching the videos on demand on EPHA’s youtube channel. The series has gathered more than 2.500 views in total to date.

The following discussions took place during 2021:

After COVID-19, what's next for EU medicines policies?

9 March 2021

Sustainable access to effective antibiotics - what should the EU do?

15 April 2021

Negotiating with pharma: lessons from the EU COVID-19 vaccine negotiations

18 May 2021

The Oslo Medicines Initiative: a new social contract with pharma

15 June 2021

EU COVID-19 vaccines procurement

Two of the episodes in 2021 focused much on the experience of the EU negotiating with pharmaceutical companies the procurement of vaccines against COVID19 which started in summer 2020. Guido Rasi, the former Executive Director of the European Medicines  Agency (EMA) looked back at the procurement initiative and the contracts signed until early 2021 and explained that Europe needs to be better prepared next time, pursuing a real partnership with the industries as opposed to simply being the client-buyer of the end products. In his view, the EU as opposed to the US did no invest sufficiently in the research, development and manufacturing of the vaccines and has therefore found itself depended on the companies business plans without being able to influence those much. He noted that the EU negotiating team was perhaps “naïve” at times and did not have a thorough understanding of companies’ strategies. He emphasized that the EU spent too much time worrying about minor issues while losing sight of the big picture. In his view, this undermined the EU’s bargaining power and resulted in “wasting” precious time.

Clemens Auer, Special Envoy for Health for Austria and Vice-Chair of the WHO Executive Board, on the other hand praised the EU’s joint procurement and shared his insights from his close involvement in the negotiations as the Co-Chair of the EU’s Steering Board tasked with signing the deals. He explained that not all companies behaved the same way and that some were more professional and reliable than others throughout the process. He reiterated that the legacy of this procurement is crucial and needs to be expanded in other areas of therapeutics. One of the key elements of this success story in his opinion was the equitable  availability of vaccine doses across the EU at the same time. Another advantage in his opinion has been that the EU use effectively its buying power and obtained very affordable prices during the first round of vaccines procurement. He called for a thorough evaluation of the negotiation process so far in order to draw some conclusions on what can be improved in the future. Last but not least, he clarified that the EU should have been tougher in the manufacturing provisions with more binding delivery timetables.

Sustainable access to effective antibiotics and the role of the EU

The April 2021 episode of EPHA’s access to medicines dialogues focused on the issue of new antibiotics development. It brought together experts from the ReAct Group and the Wellcome Trust. All speakers agreed that we need a new R&D system to address the innovation void. Speakers highlighted the fact that it has been 34 years since the last class of antibiotics was discovered. All antibiotics discovered since then are modifications of existing classes which means that resistance to them may develop faster. The difficulty in discovering and developing new antibiotics has been complicated by the underlying science on one hand as well as due to an overall withdrawal from the field by the pharmaceutical industry, leading to declining investments and loss of expertise and human resources in the antibacterial field. Rohit Malpani, an independent R&D expert explained that this is because pharmaceutical companies are addicted to high profit margins. With such extreme profit expectations in the general pharmaceutical market, a field like antibiotic development (where profits in most cases are usually much lower) has few chances of being prioritized, he remarked. The representative of the Wellcome Trust underlined the need for incentives and a collaborative approach to bring all stakeholders together to identify the best solutions to address this pipeline gap.

Rohit Malpani stressed the need to move away from the current market-based, profit-driven business model and to explore non-IP based models. In his view, intellectual-property based monopolies and exclusivities hinder meaningful innovation in his opinion. Helle Aagaard of ReAct agreed that the current model is not delivering the treatments we need, particularly in the field of new antibiotics development. She called on the public sector to steer the innovation process, beyond simply trying to entice companies to engage. She called on governments to take the lead since they are investing vast amounts of public funds in the first place anyway – as the COVID19 pandemic demonstrated as well. She explained that the public should do the priority-setting, invest the right funds and design new incentives that delink the R&D costs from the price and the sales volume of the end product. Last but not least, Tim Jinks of the Wellcome Trust explained the importance of the AMR Action Fund as an investment vehicle to support late stage antibiotic product development. The Fund will identify and invest in small companies and help them bring their most promising products to the market by offering financial and technical assistance. He clarified that this is an industry-led initiative, with the Trust being one of the investors. The fact is that there is insufficient funding for promising candidates and this is precisely the problem that the Action Fund is trying to address. He defended IP incentives for pharmaceutical companies and stressed the importance of business certainty and predictability for pharmaceutical manufacturers.

Fair pricing of medicines

The final episode of EPHA’s A2MDialogues series took place in June 2021. It zoomed in on the need for fair and affordable medicines prices, an issue which has been at the heart of EPHA’s advocacy throughout the years. In particular, the Oslo Medicines Initiative was presented by the guest speakers coming from Norway, WHO Europe and the Belgian national payer. This Initiative was launched by WHO Europe in close collaboration with the government in Norway and aims to present a new social contract between patients and the industries, a new balance between pharmaceutical companies and society. The speakers agreed that there is a systemic problem with the excessive prices of some medicines which threaten equity and the sustainability of healthcare systems across Europe. They noted that transparency in pharmaceutical systems is necessary on multiple levels including transparency of R&D costs. The representative of the Belgian National Institute for Health and Disability Insurance (RIZIV-INAMI) reiterated that there is a need for new pricing and payment methods which will reflect the true added therapeutic value of new treatments. He expressed concern over the increasing uncertainty and weak evidence of new treatments at the time of their marketing authorization and called for robust and timely post-marketing authorization evidence to substantiate the therapeutic benefits of new products. Last but not least, he said that payers will benefit from better coordination amongst them in order to exchange information and align in terms of the questions that marketing authorization holders will need to answer in order to get their products priced and reimbursed by public authorities.



Rosa Castro

Senior Policy Manager for Healthcare Delivery

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