Service on Health Issues (May19/11)
Geneva, 27 May (Heba Wanis and K M Gopakumar) - World Health Organization (WHO) Member States continue to strive for consensus on the transparency resolution initiated by Italy and by now co-sponsored by Egypt, Greece, Italy, Malaysia, Portugal, Serbia, Slovenia, South Africa, Spain, Turkey, India, Sri Lanka, Kenya, Eswatini, Russia, Andorra and Luxembourg.
A degree of consensus had been reached on Saturday evening (25 May) after nearly 34 hours of formal and "informal" negotiations during the ongoing 72nd session of the World Health Assembly (WHA).
The Ad Hoc Drafting Group, a smaller group of negotiators, reconvened on Monday morning (27 May) to finalize the resolution.
At the time of writing, tough negotiations are continuing on a contentious paragraph that urges Member States to take measures to share information on the net prices of medicines, vaccines, and other health-related products and other technologies.
However, the proposed definition of "net price" is defined as the price received by the manufacturers. According to many observers, such a definition would kill the purpose of the resolution because it reduces the scope of transparency to the price received by the manufacturers and not the price paid by the government or consumers.
As of the weekend, except for a few European countries such as the United Kingdom, there was apparently consensus on the price transparency part. The US also joined with Germany, Switzerland and Japan among others to oppose the parts on transparency of R&D expenditure and clinical trial costs.
Since the temporary release of the draft text on 23 May morning, there had been no information on the resolution in the public domain.
Third World Network (TWN) learned that a few Member States had objected to the release of the text.
The Health Policy Watch and IP Health list server reported on the near completion of the negotiations. One of the participants in the negotiations told TWN that many bracketed texts (indicating lack of agreement) were near consensus and awaiting the approval of the United States and the UK.
TWN also learned that the resolution contains reference to WIPO's controversial patent database Pat- INFORMED.
The International Generic and Biosimilar Medicines Association (IGBA), in a letter to the WIPO Director- General, stated that it is "very disappointed that WIPO did not consult with the generic and biosimilar medicines industries during the development of this initiative. It is our view that WIPO missed the opportunity of valuable insight that has led to a misapprehension of both the utility and potential impact of Pat-INFORMED".
James Love of Knowledge Ecology International, in a post to IP Health, stated: "One of the biggest challenges was on the costs of clinical trials, and here I expect the text to be pretty disappointing, on a very important topic. Pretty shocking that some countries, like US, Switzerland, Germany, the UK, Japan, Denmark, Sweden, the Netherlands, Australia, sought to block language that would "urge" countries to require disclosure of clinical trial costs, and I am waiting to see what if anything was done on disclosure and reporting of government R&D subsidies".
However, he added "the resolution does have a reference to "data on inputs throughout the value chain, including on clinical trial data and price information," which is not very strong, to say the least".
The original resolution proposed by Italy mainly urges Member States to ensure transparency in the price of medicines, clinical trial data and R&D expenditure.
It also requested the Director-General of WHO to collect and analyse data related to R&D costs, manufacturing cost, patent landscape, manufacturing know-how and clinical trial outcome and adverse effects of health technologies. Further, it requested the Director-General to develop tools to share information on prices of medicine, R&D cost, public investments, patent landscape etc.
This resolution was further amended 4 times and submitted to the WHA on 20 May. The 20 May version served as the basis for the negotiation during the WHA.
The resolution urges the Member States to implement the following:
1.1. Undertake measures to publicly share information on prices and reimbursement cost of medicines, vaccines, cell and gene-based therapies and other health technologies;
1.2. Require the dissemination of results and costs from human subject clinical trials regardless of outcome or whether the results will support an application for marketing approval, while also taking appropriate steps to promote patient confidentiality;
1.3. Require the following information be made public for medicines, vaccines, cell and gene-based therapies and other relevant technologies: (a) annual Reports on sales revenues, prices and units sold; (b) annual Reports on marketing costs incurred for each registered product or procedure; (c) the costs directly associated with each clinical trial used to support the marketing authorization of a product or procedure, separately; and (d) all grants, tax credits or any other public sector subsidies and incentives relating to the initial regulatory approval and annually on the subsequent development of a product or service;
1.4. Improve the transparency of the patent landscape of medical technologies, including but not limited to biologic drugs, vaccines and cell and gene therapies and diagnostic tests;
1.5. Report to the WHA 73 on the use of generic and/or biosimilar products and health services, and the policies and information that governments have used to enable early market entry, substitution and uptake of such products and services, including in particular those recommended by WHO in its guidelines;
1.6. Collaborate on the production of and open dissemination of research and know-how regarding the developing, manufacturing and supply of medicines, vaccines, cell and gene therapies and diagnostic tests, and help build national capacities of especially the LMIC countries and for diseases that primarily affect them, supported by WHO.
The resolution requests the WHO Director-General to:
2.1. Support Member States by providing tools and, upon their request, guidance, in collecting and analysing information on prices, costs and clinical trials outcome data for relevant policy development and implementation towards Universal Health Coverage (UHC);
2.2. Support Member States, especially the LMIC countries, in partnership with relevant stakeholders, to promote access to research and the know-how to manufacture and otherwise provide generic medicines, medicines, vaccines, cell and gene therapies, diagnostic tests and other products and services;
2.3. Collect and analyse clinical trial data with regard to medicines and the procurement prices of medicines and vaccines from national and international agencies;
2.4. Propose a model/concept for the possible creation of a web-based tool for national governments to share information, where appropriate, on medicines prices, revenues, units sold, patent landscapes, R&D costs, the public sector investments and subsidies for R&D, marketing costs, and other related information, on a voluntary basis;
2.5. Create a forum for relevant experts and stakeholders, consistent with FENSA, to develop, suitable options for alternative incentive frameworks to patent or regulatory monopolies for new medicines and vaccines that could better serve the need of Member States to attain Universal Health Coverage and the need to adequately reward innovation, utilizing information from expanded transparency of markets health-related innovations;
2.6. Create a biennial forum on the transparency of markets for medicines, vaccines and diagnostics, to evaluate progress toward the progressive expansion of transparency;
2.7. Continue its efforts to periodically convene a Fair Pricing Forum with all relevant stakeholders to discuss affordability and transparency of prices and costs relating to health-related products and services;
2.8. Formalize the biennial Fair Pricing Forum which creates a critical opportunity to discuss transparency of markets for medicines, vaccines, cell and gene therapies and diagnostics, and to evaluate progress toward the progressive expansion of transparency;
The final text would reveal the magnitude of compromises to reach consensus on the resolution.
STRONG CALL FOR TRANSPARENCY BY MANY MEMBER STATES
At the side event on the first day of the WHA (20 May), in a packed meeting room, several countries renewed their commitment towards making medicines accessible and affordable, denouncing non-transparent strategies adopted by transnational pharmaceutical corporations.
The side event "Access to medicines, vaccines and health products: A multi-dimensional approach for ensuring transparency of markets, affordable and quality products to achieve Universal Health Coverage," was organised on 20 May by Italy and the Republic of Korea, and co-sponsored by Colombia, Costa-Rica, Cyprus, Greece, Indonesia, Mexico, Mongolia, The Netherlands, Portugal, Saudi Arabia, Slovenia, Spain, Turkey and Vietnam.
Mariangela Batista Galvao Simao, Assistant Director-General for Drug Access, Vaccines and Pharmaceuticals at the WHO, who moderated the event, started off noting that globally 100 million people fall into poverty every year for having to pay for medicines and that access to medicines is a challenge that is not only related to newer technologies but to rather older medicines.
Following this, several health ministers on the panel declared their supportive positions towards accessibility and affordability of medicines, while sharing national experiences or challenges.
The Minister of Health of the Republic of Korea highlighted that drug prices are integral to achieving universal health coverage (UHC), yet prices can be excessively high by some pharmaceutical companies.
He added, "We should not forget that medicines are public goods", noting that they are meant to protect public health, which is a human right. He called upon Member States to exchange information related to procurement and pricing.
Dr. Armando Bartolazzi, Undersecretary of Health, Italy, highlighted the existing imbalance in the medicines market and intellectual property system.
He acknowledged that there is an increasing number of valuable medicines being developed, and yet they are unaffordable.
In the meantime, there is discrepancy between listed prices and actual prices of medicines, as noted by Dr. Bartolazzi, because of the secrecy of deals which companies sign with governments.
He believed transparency in relation to information on cost of R&D, medicines life cycle and prices across countries would be the solution to address this challenging situation.
More on the academic side, Prof. Soonman Kwon of Seoul National University, a health economist, gave an overview of the current status of access to high-priced medicines, providing options which are available or currently practised by governments.
He commenced by setting the scene, noting that the "system is based on monopoly". With weak negotiating powers and unclear costs of medicines R&D, along with often insufficient evidence supporting the clinical benefits, Prof. Kwon said it is challenging for governments to take decisions in relation to pricing and availing such medicines.
He referred to market withdrawal, that is, stopping domestic drug supply, as a strategy followed by multinational pharmaceutical companies in order to raise medicine prices, hence endangering patients' access to medicines.
To support this, he gave the example of Lipiodol, the only medicine used in the transarterial embolisation procedure (TACE) for patients with liver cancer, where in 2018 in Korea, the producing company Guerbet Korea cut its supply demanding a five-fold increase in price from USD 47 to USD 230. The supply of Lipiodol resumed after a two-month negotiations process which resulted in a 3.6 fold increase in its price reaching USD 170.
Professor Kwon highlighted the more known case of Novartis' Glivec, a treatment for chronic myelogenous leukemia, whose supply was stopped as the company sought to raise its price. Public reaction and pressure from cancer patient groups made Novartis put it back on the market.
In the midst of this challenging reality, there are yet options whereby countries can ensure access to affordable medicines, according to Professor Kwon.
He provided a critical reading of available mechanisms. For example, pooled procurement, which entails strong negotiations based on volumes procured is effective in the case of vaccines.
Health technology assessment (HTA), while useful in measuring the value of a medicine in terms of its benefit to patients, remains challenging to conduct in low and middle income countries where there is limited capacity to support it.
He said that the increasingly used managed entry agreements (MEA), deals between governments and producers based on undisclosed conditions, entail a huge threat to price transparency because of confidential discounts which governments get.
External reference pricing of medicines, applied in a large number of countries, does not provide clear guidance on medicines pricing because disclosed prices might not be the actual ones, given the confidential deals between governments and companies. Prof Kwon also mentioned compulsory licence as an effective negotiating tool for prices, even if not implemented.
In reference to price transparency, he highlighted the crucial role by high-income countries given the fact that this is where pharmaceutical companies start registering and pricing their new medicines, setting prices for the rest of the world. He called for high policy commitment and an empowerment of existing regional networks.
With more focus on innovation, Dr. Bruno Bruins, Minister of Health, Welfare and Sport of the Netherlands, noted the importance of striking a balance between medicine pricing and innovation of newer technologies, recognising that lack of access to medicines concerns not only new medicines but often old ones.
He said that policy makers are responsible for setting the rules, as well as changing them when necessary. He called for joint HTA whereby countries can exchange prices and fees.
Collaboration between countries was regarded as cost effective by Dr. Marta Meido, Minister of Health of Portugal, who emphasised that it was a matter of good governance and good use of taxpayers' money. She said that the current situation of having to wait for pharmaceutical companies to disclose data and information in their deals must end.
Faustino Blanco, Secretary-General of Health and Consumption of Spain, said that transparency is a shared challenge calling for a balance between public benefits and private interests.
He called for linking prices to the cost of production, highlighting that public funds are behind investment in R&D which leads to new pharmaceutical products.
Dr. Niklaos Raptis, Advisor to the Minister of Health of Greece, criticised MEAs, saying that such agreements have confidentiality clauses which public health personnel have to sign and which place them under civil liability in case they are breached.
He further explained that non-disclosure clauses do not serve public interest, but private pharma interest, and that they are common in countries whose negotiating power is not strong.
This information asymmetry, according to Dr. Raptis, where countries are not informed about rebates or prices in other countries, should be resolved through horizontal scanning of prices and sharing of information particularly at regional level such as among Mediterranean countries. He called for national legal frameworks to complement political declarations in this regard.
Other countries made relevant interventions from the floor. A representative of the South African Ministry of Health advised countries to legislate medicine pricing for transparency purposes and create a database of medicines prices.
In a passionate intervention which ended in long applause, the representative of Cyprus' Ministry of Health criticised pharmaceutical companies' strategies with small countries with low negotiating powers.
He noted that pharmaceutical companies tend to launch their new medicines in countries of northern Europe where high prices can be afforded, thus raising prices for countries like Cyprus. Giving examples of how exorbitantly high prices were charged by pharmaceutical companies in Cyprus compared to other countries, he called their practices "unethical", calling upon the WHO's support to stop them.
In conclusion of the side event, Mr. Luca Li Bassi, Director-General of the Italian Medicines Agency (AIFA), noted that differential pricing has to happen according to countries' GDP. He questioned the current framework of innovation, asking whether it is the best.
Mr. Li Bassi closed by saying that an open-minded collaborative approach is lacking when it comes to actual issues, calling for true collaboration including with the industry.