Country officials, academics and leading global health advocates this week raised one of the key concerns of this year’s World Health Assembly: innovation and access to medicines in middle-income countries. Government procurement strategies, voluntary and compulsory licensing, de-linkage models and UNITAID mechanisms were among some of the solutions put forward.
A 21 May side event to the 67th World Health Assembly, taking place from 19-24 May, discussed “Innovation and Access to medicines and vaccines: Emerging Challenges and Opportunities for Middle Income Countries,” co-organised by Médecins Sans Frontières (MSF), Knowledge Ecology International (KEI), Treatment Action Group (TAG), Oxfam, Health Action International (HAI) and Civil Society Coalition.
Middle-income countries, said Ellen ‘t Hoen, a consultant and former head of the Medicines Patent Pool, “represent the fastest growing pharmaceutical market, they are also home to significant pharmaceutical production power and potential and current innovation power, but they also are home to 80 percent of the poorest people in the world.” And critically, they often do not benefit from access programs.
Although progress assessments of access are often reported positively, the problems have not been solved and lessons have not always been learned, said ‘t Hoen, referring to the recent proposal by the Global Fund for AIDS, Tuberculosis and Malaria to establish a blue ribbon committee on tiered prices and other mechanisms.
Suwit Wibulpolprasert, from the Ministry of Public Health in Thailand, emphasised the need for governments todecidewhether medical technologies and medicinesare cost effective. “If they are not, don’t buy them,” he said. The problem is that most of these drugs are patented, but Universal Health Care central bargaining can really reduce the price, he said.
Thailand has a “health intervention assessment program institute,” which assesses high price, high-tech medicines, he said, to assess whether they are cost affective and whether they should be included in the essential medicines list. The institute assesses at which price products will be most cost effective, and proposes this price to companies for government procurement.
Thailand has received huge political pressure for some drugs, said Wibulpolprasert, so the government needs to share cost-effectiveness data with the public. Patients should be informed that it is public money that is being used to purchase these medicines.
He warned that pharmaceutical industry often sponsors patient groups to lobby for them in this way. “If the story goes on like this, every country will go bankrupt,” he said, adding that drugs are not just assessed on cost effectiveness but also on their impact.
On the issue of using the TRIPS flexibility of compulsory licensing, he said, “this should be the last thing in the world to do it. Unless you are strong enough and receive political support, don’t try to do it.” He said Thailand published two white papers on implementation of compulsory licensing. But he reiterated that price negotiation, bulk buying and rational use of medicines should be prioritised.
MICs: “Don’t Put us in Corner”
Mokhtar Warida, counsellor at the Egyptian mission in Geneva, said that “it is not fair to group all the middle-income countries in just one basket. There are variations.” Economic data to classify countries is not always the best way to deal with certain issues related to public policy, especially in the field of health, he added.
“It is not fair as well to put us in a corner,” he added. In other words, having only one policy instrument (such as a tiered pricing model based on per capita income) to deal with the complex issue of access is not reasonable. In lieu of that, governments and organisations need to have “a toolbox of instruments” that they can use according to the situation in their country.
In the case of hepatitis C (HCV) in Egypt, for instance, competition of generic medicines has proved to be effective in reducing prices and making them more affordable for consumers, Warida said. Egypt has also a universal program for patients with hepatitis, and the government almost fully finances the program to reduce the need for out-of-pocket payments.
Lastly, Warida said there is a real need to increase access to vaccines and requested that GAVI supply middle-income countries as well. The Global Fund and the UNITAID should also extend their mandate to new diseases, he suggested.
Philippe Duneton, UNITAID’s deputy executive secretary, highlighted how ambitious UNITAID could potentially become in the context of access to medicines. UNITAID’s mandate focuses on access to medicines and tests for the major pandemic diseases HIV, malaria and tuberculosis. But Duneton said it is a “right move for UNITAID to move into this space” of HCV.
There is a crucial need to pinpoint the real issues,he said. For instance, in the HIV and HCV context, the competition for generic products has been key to getting good quality products and fair prices, he said. The IP issue remains a big challenge for the development of new tests and drugs, he said, and UNITAID is the “only agency of global health to have a specific mandate” to look at how to address this challenge.
Different ways exist to address this issue, including through voluntary licensing with the Medicines Patent Pool, “but [MPP] is not the only way” he said. Patent opposition can also been a successful solution. For instance, UNITAID is providing grants to lawyers in India for this purpose.
UNITAID also gave its complete support to WHO Director General Margaret Chan’s statement that “the trade agreements under negotiation could significantly reduce access to affordable generic medicines.”
Rohit Malpani, director of policy and analysis at the Médecins Sans Frontières (MSF) Access Campaign, stressed that generic competition has been shown to be the most sustainable way to drive down costs and increase access. He said it is important for governments to make use of TRIPS flexibilities “no matter how difficult” it is for them.
Suerie Moon, from the Harvard Global Health Institute and Harvard School of Public Health, presented analyses relating to the effectiveness of tiered pricing, “often put forward as a main policy tool” to increase access.
All the evidence shows that “whenever markets are large, generic production is much more reliable than tiered pricing,” she said. “Tiered pricing doesn’t often lead to affordable pricing.” She also noted seemingly arbitrary variations between companies’ implementation of tiered pricing policies in terms of which countries are excluded and how prices are set.
However, tiered pricing can be an important tool when markets are small or risky, or in the absence of other feasible short-term options, said Moon. But even then itshould be seen as a temporary solution. The implementation of tiered pricing policies by companies leaves room for improvement, and price-setting should primarily be a government responsibility and not unilaterally controlled by companies.
James Love, president of Knowledge Ecology International, stressed that using patent monopolies for health goods “fundamentally does not work”. De-linkage alternatives for research and development should ensure that generics become the norm. The most mature discussions have been in the area of antibiotics, where GlaxoSmithKline, AstrZeneca and others have all endorsed the idea of moving towards de-linkage, he said, adding that the WHO “has not done its job in providing leadership to bring forward” this idea.
Zafar Mirza, head of the Department of Public Health, Innovation and IP at the WHO, referred to the WHO’s long history in addressing innovation and access to essential medicines. He also acknowledged the WHO’s awareness of the problem of affordable medicines access for the poor in countries that will soon or have already graduated in terms of development classification.
Speakers Share Country Experiences
Jorge Bermudez, vice-president of the Health Production and Innovation department of Fundação Oswaldo Cruz (Fiocruz) in Brazil, pointed out that affordability remains a crucial concern faced by all health systems across countries whether they are a low, middle or high-income country.
This issue of high cost of products certainly applies to HIV, HCV, cancers, and soon to multi-drug resistant TB as well, he said.
To face this challenge, the BRICS countries and developing countries should develop public health orientated management of intellectual property, which includes TRIPS flexibilities to ensure innovation and access to essential medicines, vaccines, diagnostics and blood products, he explained.
In Brazil, “one single compulsory licensing was issued years ago, which allowed a working network of public and private manufactures to face the challenge of local manufacture of HIV,” he said.
Updating of national patent law is taking place around the world, including in Brazil. Bilateral and regional free trade agreements are also still a barrier for developing countries, he added.
In this context, local production is an imperative, which needs to be put forward, he said. Since 1998, Brazil’s Constitution ensures universal access to medicines stating that, “health is a right and duty of the state.” Over the last 10 years, the government has strongly supported local production, which is included in industrial and health policy.
Brazil believes that “a universal healthcare coverage must been translated into integral, equitable and free access to all,” said Bermudez, and urged countries to move in this promising way.
Bayu Teja Muliawan, director for pharmaceutical issues at the Ministry of Health in Indonesia, shared his concerns on how to provide “affordable, safe and quality medicines.”
Since 2007, Indonesia has made “good use of the TRIPS flexibilities, especially statutory licence and patent use by government since 2007 in order to ensure the affordability of essential medicines,” he explained.
However, while this intersection between intellectual property, innovation and public health has been recognised over and over, it remains “a challenge for WHO and member states, especially middle-incomes countries to use TRIPS flexibilities when drafting intellectual property policies and promote access to affordable essential medicines,” he said.
Muliawan proposed that WHO strengthen these mechanisms in middle and low income countries to counter industry influence and ensure that countries have the ability to use TRIPS flexibilities and assess more affordable medicines.
Mirza also added that it is important that governments provide policies for local production, and said what is needed is “a new model for local production that meets the needs of the local population.”
Global Fund Response
In response to recent criticism, Christopher Games, the chief procurement officer at the Global Fund, said he thought in general that there is alignment between the Fund’s approach and what was being said in the room.
He stressed that the Global Fund is not pushing tiered pricing, but that it is one of a list of items, and distributed an “Equitable Access paper” listing around 17 other items they are considering.
“If I could have ‘It’s not about tiered pricing’ tattooed on my forehead, I would,” Games said.
Regarding the mention by panellists of the need for a “toolbox” for governments rather than a single approach, Games said, “I think it’s where we’re headed.”
Source: Intellectual Property Watch