TWN Info Service on Intellectual Property Issues (May19/07)
30 May 2019
Third World Network

WHO: Member States adopt resolution on transparency in medicine pricing

Geneva, 28 May (K M Gopakumar): The 72nd World Health Assembly (WHA) of health ministers on 28 May adopted the resolution on “Improving the transparency of markets for medicines, vaccines, and other health products” in what is considered as a first step to improve the transparency on medicine pricing and other factors impacting prices such as clinical trial costs.

The 72nd WHA took place in Geneva on 20-28 May with long drawn negotiations over what became known as the “transparency resolution”.

The resolution urges the WHO Member States in accordance with their national and regional legal frameworks and contexts to:

• Take appropriate measures to publicly share information on the net prices [FOOTNOTE] of health products.

[The footnote states: “For the purposes of this resolution, net price or effective price or net transaction price or manufacturer selling price is the amount received by manufacturers after subtraction of all rebates, discounts, and other incentives”.]

• Take the necessary steps, as appropriate, to support dissemination of and enhanced availability of and access to aggregated results data and, if already publicly-available or voluntarily-provided, costs from human subject clinical trials regardless of outcomes or whether the results will support an application for marketing approval, while ensuring patient confidentiality
• Work collaboratively to improve the reporting of information by suppliers on registered health products, such as reports on sales revenues, prices, units sold, marketing costs, and subsidies and incentives
• Facilitate improved public reporting of patent status information and marketing approval status of health products.
• Improve national capacities, including through international cooperation, open and collaborative research for development and production of health products, especially in developing countries and low- and middle-income countries (LMICs), including for diseases that primarily affect them.

Further, the resolution requests the WHO Director-General to:

• Continue to support Member States, upon their request, in collecting and analysing information on economic data across the value chain for health products and data for relevant policy development and implementation towards achieving Universal Health Coverage (UHC);
• Continue supporting Member States, especially LMICs, in developing and implementing their national policies relevant to the transparency of markets for health products, including national capacities for local production, rapid and timely adoption of generic and biosimilar products, cost-effective procurement, product selection, quality assurance and supply-chain management of health products.
• Support research on and monitor the impact of price transparency on affordability and availability of health products, including the effect on differential pricing, especially in LMICs and small markets, and provide analysis and support to Member States in this regard as appropriate.
• Analyse the availability of data on inputs throughout the value chain, including on clinical trial data and price information, with a view to assessing the feasibility and potential value of establishing a web-based tool to share information relevant to the transparency of markets for health products, including investments, incentives, and subsidies.
• Continue WHO’s efforts to biennially convene the Fair Pricing Forum with Member States and all relevant stakeholders to discuss affordability and transparency of prices and costs relating to health products
• Continue supporting the existing efforts for determining patent status of health products and promoting publicly available user-friendly patent status information databases for public health actors, in line with the Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property, and to work with other relevant international organizations and stakeholders to improve international cooperation, avoid duplication of work, and promote relevant initiatives
• Report to the WHA74 (through the Executive Board’s 148th session) on progress made in implementing this resolution

Unlike the initial draft, first proposed by Italy and then supported by a group of countries, the resolution does not create any responsibility on the part of Member States to ensure transparency on R&D cost and clinical trial cost.

Further, the resolution urges Member States to take measures to disclose the net price i.e. the price received by the manufacturer instead of the price paid by the government or customers. One concern is that this may result in disclosure of full elements on prices including the mark-up for distributors. However, one Member State justified the formulation of the text and said that the net prices would help to calculate the other elements of the price (such as R&D and clinical trial costs that were contentious for the pharmaceutical industry).

The resolution also requires that costs from human subject clinical trials, regardless of outcomes, be made publicly available or be voluntarily provided.

Similarly, instead of urging Member States to take measures to obtain information by suppliers on registered health products, such as reports on sales revenues, prices, units sold, marketing costs, and subsidies and incentives, the resolution urges Member States to “work collaboratively” to improve the reporting of such information by suppliers on registered health products.

However, the resolution provides a strong mandate for the Secretariat to provide support to Member States on the following areas:

• Analysing information on economic data across the value chain for health products and data for relevant policy development and implementation towards achieving Universal Health Coverage;
• Implementing their national policies relevant to the transparency of markets for health products, including national capacities for local production, rapid and timely adoption of generic and biosimilar products, cost-effective procurement, product selection, quality assurance and supply-chain management of health products.

Further, the resolution provides a clear mandate to the WHO Secretariat to “analyse the availability of data on inputs throughout the value chain, including on clinical trial data and price information”.

The resolution clearly brings out the division within Europe between the countries with pharmaceutical industry such as Germany, France, the United Kingdom, Switzerland, Sweden and Denmark on the one hand, and countries that do not have strong pharmaceutical industry such as Spain, Portugal, the Netherlands, Austria and Norway. However, a European country negotiator told TWN that the Netherlands was not active in the negotiation irrespective of their public statements in support of transparency outside the room.

Though the resolution was adopted by consensus i.e. without any objection from the Member States, Germany, Hungary and the UK stated their disassociation from the resolution at the WHA plenary. While stating its commitment to transparency and access to medicines, Germany cited leaking of text, which resulted in the targeting of its position, as a reason for its disassociation from the resolution. In fact Germany walked out of the negotiation on Friday (24 May) citing the leaked text. The leaked text revealed Member States’ proposals on certain contentious issues.

The UK also recalled its commitment to transparency and access to medicines, but cited the lack of time and absence of discussion at the Executive Board as its reasons for disassociation from the resolution. Hungary too shared the concerns of Germany and the UK and declared its disassociation from the resolution.

Thailand disassociated from Operational Paragraph 1.2 i.e. “Take the necessary steps, as appropriate, to support dissemination of and enhanced availability of and access to aggregated results data and, if already publicly-available or voluntarily-provided, costs from human subject clinical trials regardless of outcomes or whether the results will support an application for marketing approval, while ensuring patient confidentiality.” According to Thailand, instead of ensuring mandatory disclosure of clinical trial costs, the resolution promotes only the voluntary disclosure of such information. It also stated its right to publish the clinical trials costs.

The USA supported the resolution, stating the commitment of the Trump Administration’s initiative to legislate to ensure competition in the pharmaceutical market through transparency in pricing. It called on other Member States to join, and increase transparency. It also extended its full support to transparency of patent information and timely information of clinical trials keeping in mind importance of confidentiality.

Spain objected to the statements of Germany, the UK etc. and stated that adoption of the resolution is a reasonable step towards facing a problem that affects us all. Further, Spain said, “We would prefer fewer reservations and more provisions on costs of R&D and clinical trials. Industry must understand and this is a path we cannot stem away from”.

Portugal said that, “this resolution can be a game changer in the area of access of medicines. Over the last few years, Portugal has expressed concern about high prices in this Assembly and impact of prices of medicines. Transparency is a fundamental value of modern, open societies. This is why Portugal joined at the very beginning the sponsoring of this resolution. We are very satisfied by this resolution. Of course, we would prefer stronger language on prices of costs, including R&D. Finally, we believe this resolution has the potential of our goal to achieve UHC and realization of the right to health. WHO has a critical role in this regard and we count on its leadership in the implementation.”

France, one of the initial opponents of the resolution, supported the adoption of the resolution. It stated: “Price transparency is a commitment which France is trying to make for a long time. Prices of medicines are published in the official journal of the Republic. We support international negotiations at WHO on all processes of price transparency, and we give support to the resolution. We nonetheless regret that preparations have not been as good as they might have been and this puts obstacles in the implementation of the resolution. We could learn in the future.” France changed its position after the public pressure against its opposition to the resolution during the informal consultation on 7 and 10 May.

Developed countries such as Australia, Japan, Switzerland and Canada supported the resolution while agreeing with the concerns of the UK and Germany.

Brazil congratulated Italy for its leadership and the knowledge and wisdom with which its delegate had facilitated consensus among the Member States. Brazil stated that it concurs that no country whatsoever should be intimidated by any form of intimidation into different positions from their national positions. “But we also note for the record that this process given its open-ended, transparent, inclusive, exhaustive nature has given all WHO Member States the proper opportunity to participate, to make views clear and transparent including to civil society”.

Brazil also challenged the view that the resolution was not discussed at the January Executive Board meeting. It stated that with regard to the agenda item 12.10 on public health implications of the Nagoya Protocol (on access and benefit sharing), where we took a decision on at this Assembly, no session was held at the Executive Board in January but Member States were still able to arrive at a consensus that has far reaching implications.+

(The reports of proceedings of the WHO Watch team of the People’s Health Movement contributed to this article.)