Interview of Ella Weggen, senior global health advocate at Wemos. She focuses on the realization of equitable access to affordable medicines and other medical technologies worldwide. She raises awareness about the causes of inequity and their solutions among policymakers to initiate change.
1. According to Wemos, why does transparency matter when it comes to access to medicines?
Greater transparency is needed to assess and address the problems in the pharmaceutical system. In 2019, a WHO resolution on transparency of markets for pharmaceutical products was adopted in which Member States committed to share information notably on net prices of health products, R&D subsidies and incentives, and data of clinical trials. The EU pharmaceutical strategy is a good opportunity to kick-start the process of implementing the resolution at the regional level. States are reluctant to take the first step on their own, out of fear that it will be to their disadvantage if they are the only ones to do so.
Now, each country negotiates with pharmaceutical companies behind closed doors and has no idea if the proposed price by the industry is higher or lower than the one they proposed in another country. The industry, especially when a company has a monopoly on a life-saving drug, has leverage to push the prices to extremely high levels. If the EU fosters information sharing between Member States (on net prices, R&D costs) and legislation to move towards a cost-plus pricing methodology, it will empower States to negotiate better prices.
2. In its contribution to the public consultation on the new EU pharma legislation, the Dutch government is pushing for better transparency of R&D costs and a better collaboration between Member States to improve access to medicines. How much can a member state influence the final legislative & non-legislative outcomes of the EU pharmaceutical strategy? What are the roles of the Commission and the Council in these processes?
The Netherlands could reclaim its international leadership in improving access to medicines. It did so several years ago, when Minister Schippers of Health, Welfare and Sport together with Minister Ploumen of Foreign Trade and Development Cooperation were in charge, and made access to medicines their priority. In 2016, Minister Schippers wrote a vision on access to medicines and made it one of her priorities during the Dutch EU presidency. It is easier to influence the strategy being the president of the EU, but the Netherlands could take a stance and make sure the current president of the EU takes this topic as one of the priorities.
The Dutch government is already on the right track by pushing for better transparency of the R&D costs on the EU level and a better collaboration between Member States to improve access to medicines. The Netherlands has set up an initiative called Beneluxa where they cooperate and do negotiations together with Belgium, Luxemburg, Austria and Ireland, often working on highly priced medicines, like Zolgensma. They do horizon scanning, information sharing, policy exchange, technology assessment, and collaborate on pricing and reimbursement. I think this is a good set-up, that could be extended at the European level.
This summer, the Dutch government published a report that they commissioned on the R&D costs of pharmaceutical products. Despite the fact that it did not want to attach any conclusions to the findings yet, it however shows the interest that it has in the matter. Within the Dutch and European context this report could provide leads for NGOs to promote not only transparency in R&D costs, but also other transparency issues like net pricing.
With the Dutch report on R&D costs, there seems to be a rekindled interest of our government to raise the issue of transparency in pharmaceutical products. For national advocacy organizations it is crucial to continuously push their capitals for progressive positions on transparency. Each one of the Member States can decide to really take the issue further. That is what we as Wemos are trying to achieve: we want the Dutch government to champion the topic and become an advocate within the Council.
3. What are your top recommendations to improve transparency and access to medicines through the EU pharma legislation?
We have several recommendations in general, and also specifically related to transparency. I have already mentioned some aspects where we think transparency is key, for example on net pricing, on the cost of R&D, on the amount of public funding, but also on the contract agreements between the EU and pharmaceutical companies. These are all aspects we believe should be more transparent, and legislation might be needed for that. This concerns the implementation of the 2019 WHO transparency resolution, because no country on its own will do so: it will not benefit them. The EU needs to be in charge and create a level playing field, which will benefit all the Member States.
We believe in alternative funding and pricing models that can encourage pharmaceutical companies to innovate and to charge reasonable prices, for example the pharmaceutical cost-plus-pricing method: prices of pharmaceutical products are based on transparent (R&D and other) costs, plus a reasonable profit margin. This method could improve access to medicines, foster a healthy market and leave sufficient room for competition.
I believe there is a lot of things that need to be done, and transparency is one of the steps. I want to quote the contribution of the Dutch government on the revision of the pharma legislation: “Transparency is not an endpoint of itself but a way to ensure good practice and willing from decision-making. Transparency is one of the principles of good governance. It is currently not addressed and deserves attention during the revision process. Pharmaceutical system is opaque. The lack of transparency around cost of R&D, data and results, clinical trials and environmental risk data, public investment, products in the pipeline, actual prices in the member States impairs the ability of member States to make fully informed decisions, purchasing medicines and negotiating prices for their population. The principle of transparency in the process should be integrated into pharmaceutical legislation addressing both stakeholders as well as public authority responsibilities”.
This position of the Dutch government really exemplifies how a leadership position on transparency could look like. I think it would be really good for other national NGOs to push their governments in a similar direction so we can make sure these positions are translated into actual policies.
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