Little Progress Over Price Transparency Resolution; Negotiators Behind Closed Doors

Secrecy was the watchword Friday as countries huddled together behind closed doors trying to reach agreement on a WHA resolution that would shed more sunshine on the real prices of medicines in national and global pharmaceutical markets.

A formal plenary session scheduled for today was delayed until at least Monday, while debate continued into Friday evening over the most contentious issue: public pharma disclosure of costs for R&D, including any public subsidies or incentives received, at the time of a drug’s regulatory approval. The negotiations were to resume again Saturday morning.

Among the leading critics of the transparency resolution, the United Kingdom remained vocally critical of the draft text in today’s sessions, while Germany’s opposition was somewhat more muted, observers told Health Policy Watch.

A group of civil society organisations working in sub-Saharan Africa, meanwhile, lambasted the resolution’s three leading opponents, Germany, France and the UK, for failing to consider the needs of developing countries.

“The German government’s opposition to this resolution is in sharp contrast to its claim to act as a leader in global health. A true champion of global health would vocally support this initiative,” said the open letter addressed to Jens Spahn, Minister of Health, and signed by 66 African NGOs based in South Africa, Uganda, and Zimbabwe, including multiple cancer and non-communicable disease advocacy groups. “We support maximum transparency in the prices for medicines – transparency means our governments can negotiate fair prices rather than negotiating blindly. We are requesting the German government to stand in solidarity with people most at risk of suffering and death because of lack of access to medicines by abandoning your obstruction of this powerful resolution.” Identical letters were sent to French Health Minister Agnès Buzyn, and Matthew Hancock, Secretary of State for Health and Social Care of the United Kingdom.

The resolution, introduced by Italy in February and revised in April, has been the focus of enthusiastic support by a group of southern European countries, as well as countries in Africa and Asia. Global humanitarian aid groups, such as Doctors without Borders, have argued vociferously that a strong resolution yielding more public data on prices for health products could help bring down costs and increase access to desperately needed drugs in developing countries.

While the debate had initially seemed to pit politically powerful northern European countries such as Germany and the UK against a bloc of countries in southern Europe, including not only Italy but Greece, Spain, Serbia, Slovenia and Turkey, some Scandanavian countries were also showing signs of support today for the resolution.

“Finland is in favour of a strong mandate of the WHO on this issue,” a member of the Finnish delegation told Health Policy Watch, as tired negotiators closed their session Friday evening. Norway, while not an official sponsor, has also indicated support, observers said.

Negotiators for Switzerland along with the United States, have likewise been positive about provisions calling for publication of list prices of medicines sold and purchased in national markets. But representatives were more reluctant about clauses asking national governments to require pharma firms to disclose R&D and clinical trial costs for drugs at the time of regulatory approval – even if funding comes from public sources.

Observers said that the United States along with Japan, also raised a challenge today over a procedural matter, arguing that WHO should not have released a comment-ridden version of the text yesterday, highlighting still vigorous debate over the transparency issue.

One resolution co-sponsor told Health Policy Watch that the “drafting group,” which swelled to several dozen countries at certain points today, remained divided on the text’s publication. Some representatives said they had no problem publicising their position, others defended a policy of secrecy.

A WHO official, meanwhile, told Health Policy Watch that yet another revised version of the resolution is expected to be published on Monday, along with a expanded list of co-sponsors – as more countries are joining the original group of 11 countries that initially supported the draft.

Delegates cooped up in Room XXIV of Geneva’s UN Headquarters, the Palais des Nations, were otherwise reluctant to share any information on the direction of the discussions, reflecting the sensitivity of the negotiations.

As closed door sessions continued, today’s WHA plenary debate on the draft resolution, originally scheduled for last Tuesday the 21st, the second day of the World Health Assembly taking place from 20-28 May, was postponed again. The item has now been scheduled to come to the floor on Monday, according to the WHA daily journal schedule.

At the opening of the WHA, on Monday, U.S. Health and Human Services Secretary Alex Azar said: “A top priority of the American people, and therefore a top priority of mine, is the availability of affordable, safe, and effective medicines. Over the last year, President Trump has introduced more competition and negotiation to the way the United States pays for medicines.”

“We proposed reference pricing for medications for the first time, injecting competition into a large government-run program that previously accepted any price manufacturers suggested…. under President Trump, the United States will never be a bystander to abusive drug pricing practices,” he said.

However, at another event on Monday, Azar also told journalists that he was unsure if lifting the veil of corporate secrecy over costs for R&D would pay off in terms of actually reducing drug prices.

“The question around R&D is: is that actually meaningful transparency, and information that would go into the pricing and negotiation of products? We suspect that is not necessarily the highest value area for our efforts, but we continue to look at that. But our biggest concern is pricing transparency as well as transparency of patents,” Azar said.

At the same time, critics point out that the costs of drug development often include public subsidies and tax breaks. And they are a critical component of final drug prices – whereby higher prices are justified with the idea that an “innovation incentive” are required to stimulate further research.

Yet, in the absence of more hard data on R&D costs, the oft-cited reference value of US$1 billion per product, which may be required to bring a medicine from discovery phase to market, has no way of being verified.

John Zarocostas contributed reporting to this story.

Image Credits: Max Pixel, Catherine Saez.

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