What the recent discussions on access to medicines at WHO’s Executive Board tell us

Originally published in International Health Policies

When the Tedros administration assumed office in 2017, there was some apprehension in certain sections of the global health community, about the extent to which WHO would protect and pursue the contentious issue of access to medicines.

Less than two years on, one can be fairly convinced that this administration is serious in leading from the front and some might even say, successfully walking the tightrope – for now.

“Innovation without access does not mean anything,” Director General Dr Tedros Adhanom Ghebreyesus, told member states during a discussion on access to medicines last month at WHO’s 144th Executive Board meeting.

The event saw member states consider two agenda items on access to medicines.

THE WHO ROADMAP ON ACCESS TO MEDICINES

First, the WHO roadmap on access to medicines and vaccines was taken up at the Board meeting.

The roadmap is a product of consultations and discussions with member states during 2018 on ways to work on access to medicines, vaccines and other health products, between 2019–2023. In May 2018, the 71st World Health Assembly had considered a report on addressing the global shortage of, and access to, medicines and vaccines. The report had prescribed a list of priority options for actions.

The roadmap reflects existing WHO mandates in key Health Assembly resolutions of the last 10 years related to access to safe, effective and quality medicines, vaccines and health products, and also the Thirteenth Global Programme of Work, 2019–2023, the secretariat has said.

In their statements on the roadmap, countries stated their wide-ranging suggestions and concerns on the roadmap. While some countries pushed for regulatory harmonization such as Germany, others including Brazil cautioned against it. India asked for greater clarity on the resources to implement the roadmap.

Some stakeholders are not comfortable with the concepts of “fair pricing” and “equitable access” – as discussed in the roadmap. In the roadmap, WHO has referred to a fair price as one that is affordable for health systems and patients and at the same time provides sufficient market incentive for industry to invest in innovation and the production of medicines.

It is not clear when and how fair pricing as a term became an acceptable phrase in a WHO document, one observer remarked. During the discussion, the delegate representing Iran said, that there is no shared understanding on what “fair pricing” means and that WHO must stick to “affordable” medicines instead. In its statement, Romania on behalf of the EU, suggested that talking about market failure alone will not help.

Some believe that the fair pricing debate can be useful to arrive at more meaningful discussions on access issues. One developing country delegate believes that “fair pricing” can be a lever to open the wider discussion on access to medicines. “At least, the fair pricing discussion will serve the purpose of getting some of the European countries at the table to talk about high prices of medicines,” he said in an off-the-record conversation. (The previous fair pricing forum was in The Netherlands in 2017.)

To be sure, European countries have already been drawing attention to rising drug prices.

MEDICINES, VACCINES AND HEALTH PRODUCTS – CANCER MEDICINES

During the EB proceedings, The Netherlands among others drew attention to its efforts to get more transparency on drug prices, in the context of the discussion on WHO’s cancer report.  Italy in fact called for a resolution at the next World Health Assembly on transparent pricing of medicines. In a statement, Italy suggested that WHO must enhance and broaden the discussion on prices and transparency of medicines to improve competition, affordability and availability of drugs.

High prices of drugs continued to dominate discussions at the Board. Member states came together to note  the crucial report on cancer medicines.

The WHO issued this comprehensive 171 page report in December 2018 following a resolution on cancer prevention and control in the context of an integrated approach at the 2017 World Health Assembly. The report untangles the complicated and connected issues of price of drugs, costs to make drugs, the incentives to invest in R&D; and whether these mechanisms should be transparent for the sake of public interest and good governance. The industry, represented by IFPMA has said that the report is flawed.

Some WHO insiders say that the report is very “un-UN” like in its tone, because it speaks directly. Apart from saying that companies set prices according to their commercial goals and focus on extracting the maximum amount that a buyer is willing to pay, it essentially said that an over-incentivized industry may be distorting investment and stifling innovation.

The report, supported with more than 400 references, was crafted through several stages of consultations and meetings. There were consultations with member states on the report. Sources say, no objections were raised by any country on the scope of the report. The secretariat reported that there were several meetings with the Essential Medicine List Cancer Medicines Working Group and an informal advisory group on availability and affordability of cancer medicines, whose experts provided advice on the technical approach to assessing benefits of cancer medicines, the scope of the report, analytical feasibility and case studies, and suggested options that might improve the affordability and accessibility of cancer medicines.

As I reported recently, countries have called the report a milestone, a tour de force among others. It is now seen to be an important reference for the future and is shaping international cooperation and dialogue on addressing rising prices of cancer drugs in the wider context of access to medicines.

Not all stakeholders were happy with the report. Notably, the US and IFPMA asked WHO why the private sector was not consulted for the cancer report.

Dr Mariângela Batista Galvão Simão, assistant director-general for drug access, vaccines and pharmaceuticals, gave a clear debrief on how the cancer report was shaped, and admitted to the constraints in involving the private sector for the cancer report.

She informed the executive board during the discussions, “We believe that it would have been a case of perceived conflict of interest by consulting industry on this report. We would have been open to receiving information about net prices of individual cancer medicines their specific R&D costs, for example. But we believe this information would have been difficult to obtain from industry stakeholders.” She added that information from pharmaceutical companies can be included in an addendum to the report. The information furnished in the report is based on publicly available data.

This was not the only occasion when WHO top brass spoke in clear terms.

In a related discussion on the roadmap on access to medicines, the US continued to reiterate, as before, that IP related issues (“trade deliverables”) fall outside the expertise and mandate of WHO. In its statement, Canada also urged for more collaboration with WIPO and WTO on these matters.

Soon, Director General Tedros defended WHO’s turf on the IP territory, while acknowledging the continued need to work along with WTO and WIPO on these matters. He said that it has indeed been very much a part of the mandate of WHO to address matters of intellectual property in relation to public health.

Ultimately how far WHO will go on these issues, will be a function of how it handles the sustained pressure from many quarters – some overt and others subtle. This space will get more interesting – the rope will get tighter.

We will likely hear more. “Transparency is good for governance and it is good for health,” Dr Simão declared during one of her interventions at the meeting.

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