Facing up to the world’s critical health crises
The world is facing multiple crises in public health, from how to cope with new and old epidemics and the explosive cost of new medicines, to the threats from antimicrobial resistance. These issues were discussed at the WHO’s World Health Assembly held in Geneva. This issue of South Bulletin focuses on the WHA and health issues.
We also highlight, in three articles, the increasingly “hot topic” of taxation, especially international discussion and action on tax evasion, tax avoidance and tax havens. Such increased concerns are a good trend, but developing countries need to have a say in decisions on global cooperation on tax issues.
To download the entire South Bulletin, please click here. To read individual articles, please see below.
Facing up to the world’s critical health crises
The recent World Health Assembly discussed the manifold global health crises that the world is unprepared for, and adopted resolutions to act on many issues.
By Martin Khor
The global health situation is facing many critical challenges, and multiple actions must be taken urgently to prevent crises from boiling over.
This is the impression one gets from this year’s World Health Assembly held in Geneva on 23-28 May.
The WHA is the world’s prime public health event. This year 3,500 delegates from 194 countries took part, including Health Ministers of most countries. The one-week session provided a snapshot of the major medical problems and the actions being taken or proposed to deal with them.
In her opening speech, World Health Organization Director-General Dr. Margaret Chan gave an overview of what went right and what is missing on the global health front.
First, the good news – 19 000 fewer children dying every day, 44% drop in maternal mortality, 85% of tuberculosis cases that are successfully cured, and the fastest scale-up of a life-saving treatment in history, with over 15 million people living with HIV now receiving therapy, up from just 690 000 in 2000.
Aid for health became more effective. Health is now seen as an investment for stable and equitable societies, not just a drain on resources.
Then Dr. Chan described how health has evolved from a local to a globalised problem, with air pollution becoming a transboundary health hazard also causing climate change, and drug-resistant pathogens being spread through travel and food trade.
The recent Ebola and Zika outbreaks showed how global health emergencies can quickly develop. There is a dramatic resurgence of emerging and re-emerging infectious diseases, which the world is not prepared to cope with.
Dr. Chan gave three examples of the global health landscape being shaped by slow-motion disasters: climate change, antimicrobial resistance, and the rise of chronic non-communicable diseases as the leading killers worldwide.
These are man-made disasters created by policies that place economic interests above health and environmental concerns. Fossil fuels power economies, medicines for treating chronic conditions are more profitable than a short course of antibiotics, and highly processed foods gain a bigger market than fresh fruits and vegetables.
Unchecked, these slow-motion disasters will eventually reach a tipping point where the harm done is irreversible. For antimicrobial resistance, “we are on the verge of a post-antibiotic era in which common infectious diseases will once again kill.”
On moving ahead, Dr. Chan pinpointed universal health coverage as the target that underpins all others in the health aspect of the Sustainable Development Goals. It is the ultimate expression of fairness that leaves no one behind, and can meet people’s expectations for comprehensive care.
The Director-General’s speech provided a framework for the many discussions and resolutions that followed.
The Assembly agreed that the WHO set up a new Health Emergencies Programme to enable it to deal operationally better with disease outbreaks and humanitarian emergencies. It aims to enable WHO to lead in providing rapid, predictable, and comprehensive support to countries and communities as they prepare for, face or recover from emergencies caused by any type of hazard to human health, whether disease outbreaks, natural or man-made disasters or conflicts.
On antimicrobial resistance, many countries reported on actions they have taken in light of the Global Action Plan adopted at the World Health Assembly in 2015. Several developing countries requested for funds and technology such as laboratory equipment to diagnose resistant strains of pathogens, to help them meet the deadline of making national action plans by 2017.
The WHO produced a new paper on options to set up a global stewardship framework to support the development, control and appropriate use of new antimicrobial medicines and diagnostic tools, and also gave a report on the past year’s actions.
The Secretariat has made quite a lot of progress, but action on the ground is still slow. For example, in the Asia-Pacific region only six countries have completed their national plans and another five have plans that are being developed.
At the end of the discussion, the WHO’s assistant Director-General Keiji Fukuda said the next year would focus on three elements: make progress on the Global Action Plan, further develop the global stewardship framework, and involve political leaders in the issue through a heads of states meeting in the United Nations headquarters in New York in September.
There were two issues on childhood nutrition that highlighted the need to put health concerns above corporate interests. The first was childhood and adolescent obesity. In 2014, an estimated 41 million children under 5 years were affected by overweight or obesity, and 48% of them lived in Asia and 25% in Africa.
The marketing of unhealthy foods to children was identified by the WHO Commission on Ending Childhood Obesity as a major factor in the increase in childhood obesity.
The Commission recommended the promotion of intake of healthy foods and to reduce the intake of unhealthy foods and sugar-sweetened beverages by children and adolescents. It proposed effective taxation on sugar-sweetened beverages and curbing the marketing of unhealthy foods.
The World Health Assembly welcomed the Commission’s six recommendations and called on the WHO Secretariat to develop an implementation plan to guide further action and also recommended Member States to develop national responses to end childhood and adolescent obesity.
On the second issue, the Assembly welcomed the WHO guidance on ending the inappropriate promotion of foods for infants and young children. According to the guidelines, to support breastfeeding, the marketing of “follow-up formula” and “growing-up milks” – targeted for babies aged 6 months to 3 years – should be regulated in the same manner as infant formula for 0 to 6-month-olds.
The WHO guidance also indicates that foods for infants and young children should be promoted only if they meet standards for composition, safety, quality and nutrient levels and are in line with national dietary guidelines. It also recommends that health professionals do not accept gifts or free samples from companies marketing these foods and that companies do not sponsor meetings of health professionals.
On another issue, access to medicines and vaccines, the WHA agreed on measures to address the global shortage of medicines and vaccines, including monitoring supply and demand, improving procurement systems and improving affordability through voluntary or compulsory licensing of high-priced medicines.
An interesting and well-attended side event was organised by India on behalf of the BRICS countries (Brazil, Russia, India, China and South Africa) on the effects of free trade agreements on access to medicines.
After remarks from the health ministers of the BRICS countries, the main speaker, American law professor Frederick Abbott, gave reasons why the Trans Pacific Partnership Agreement (TPPA) goes beyond the WTO’s intellectual property standards and would make it much more difficult for the TPPA members to have access to affordable medicines.
His warning was complemented by the head of UNAIDS Michel Sidibé who estimated that the US$2 billion annually now spent to treat 15 million AIDS patients could jump to US$150 billion if there were no generic drugs and patients had to use originator drugs at US$10,000 a person a year. South Africa’s heath minister agreed that patents pose a barrier to access to medicines.
Air pollution was one of the environmental issues highlighted. Every year, 8 million deaths are attributed to air pollution – 4.3 million to indoor and 3.7 million to outdoor air pollution.
The Assembly welcomed a new WHO road map to respond to air pollution’s health effects. This outlines actions to be taken in the period 2016 – 2019: expand knowledge on the health impacts of air pollution and effective policies to address it; enhance systems to monitor and report on the SDGs’ air pollution-related targets; leverage health sector leadership and coordinated action to raise awareness of air pollution; and enhance capacity to address air pollution’s health effects through training, guidelines and national action plans.
Chemicals also need to be soundly managed, since 1.3 million deaths worldwide are caused by exposure to chemicals such as lead and pesticides. The World Health Assembly committed to ensure chemicals are used and produced in ways that minimize adverse health and environmental effects by 2020.
Agreed actions include countries cooperating by the transfer of expertise, technologies and scientific data, and exchanging good practices to manage chemicals and waste. The WHO will develop a road map with actions to meet the 2020 goal and the associated SDG targets.
A controversial issue that has taken two years of negotiations was how the WHO should relate to non-state actors. The World Health Assembly finally adopted the WHO Framework of Engagement with Non-State Actors (FENSA), which provides the WHO with policies and procedures on engaging with NGOs, private sector entities, philanthropic foundations and academic institutions.
On one hand, there is the aim to strengthen WHO’s engagement with the non-state stakeholders. On the other hand, there is the need for the WHO to avoid conflicts of interest that may arise when corporations and their foundations, associations and lobbies wield large and undue influence if they are allowed to get too close to the WHO. Civil society groups and several developing countries are concerned about how this corporate influence is undermining the WHO’s public health responsibilities, and that FENSA will worsen rather than reverse this trend.
The Sustainable Development Goals (SDGs) is a very topical issue and the Assembly agreed on steps to pursue the health-related goals.
There was agreement to prioritize universal health coverage; to work with actors outside the health sector to address the social, economic and environmental causes of health problems, including antimicrobial resistance; to expand efforts to address poor maternal and child health and infectious diseases in developing countries; and to put a greater focus on equity within and between countries, leaving no-one behind.
The WHO is requested to take steps to ensure it has the resources it needs to achieve the SDGs and to work with countries to strengthen their ability to monitor progress towards the goals.
The WHA also adopted many other resolutions, including on International Health Regulations; tobacco control, road traffic deaths and injuries; HIV, viral hepatitis and sexually transmitted infections; Mycetoma; Integrated health services; Health Workforce; Global plan of action on violence; prevention and control of noncommunicable diseases; Global Strategy for Women’s, Children’s and Adolescents’ Health; and healthy ageing.
Martin Khor is the Executive Director of the South Centre. Contact: director(a)southcentre.int
WHO Member States concerned over unaffordable prices of medicines
By Mirza Alas and K M Gopakumar
World Health Organization Member States once again raised concerns over unaffordable prices of medicines at the recent annual meeting of health ministers and high level officials.
Many countries expressed the view that high prices of medicines will be a barrier for the implementation of key global health strategies during their interventions on the adoption of the three global health sector strategies on HIV, viral hepatitis and sexually transmitted infections (STIs) (Documents A69/31, A69/32 and A69/33) for the period 2016-2021 at the 69th World Health Assembly (WHA) that took place in Geneva from 23 to 28 May.
These three different strategies pave the way for comprehensive actions in prevention of, and treatment for, HIV, viral hepatitis and STIs. Sustainable Development Goal (SDG) 3 sets specific targets on these diseases along with other health conditions as part of the 2030 Agenda for Sustainable Development adopted last year by Heads of States and Governments.
[SDG target 3.3: By 2030, end the epidemics of AIDS, tuberculosis, malaria and neglected tropical diseases and combat hepatitis, water-borne diseases and other communicable diseases.
SDG 3.7: By 2030, ensure universal access to sexual and reproductive health-care services, including for family planning, information and education, and the integration of reproductive health into national strategies and programs.]
All three strategies aim to enhance access to treatment along with prevention. For instance, the strategy on viral hepatitis states: “where viral hepatitis transmission is halted and everyone living with viral hepatitis has access to safe, affordable and effective care and treatment.” However, while the strategy identifies medicines and diagnostics as unaffordable for most, it also identifies the main priority actions by WHO as advocating for strategies to reduce prices and provide technical support to countries for developing strategies to negotiate price reductions with manufacturers.
Access to treatment for hepatitis C is a tremendous challenge in both the developed and developing countries due to the exorbitant high prices of originator medicines. The challenges put forward by developing and developed countries on access to affordable treatments resonate with a recent study: Prices, Costs, and Affordability of New Medicines for Hepatitis C in 30 Countries: An Economic Analysis published by the medical journal, PLOS Medicine where the authors looked at the prices for hepatitis C and how current prices will represent huge proportions on the health budgets and therefore many countries have had to restrict access to treatment.
The study found that: “The total cost of treating all patients with hepatitis C would be equal to at least a tenth of the current annual cost for all medicines in all of the countries studied. In some countries where prices are high and the burden of disease is large, the total cost of treating all infected patients would be more than the cost of all other medicines put together.”
The WHO strategies stress the need for using the flexibilities in the Trade-Related Aspects of Intellectual Property Rights Agreement (TRIPS) to ensure access to affordable treatment. The Viral Hepatitis Strategy states:
“The demand for affordable treatment for viral hepatitis B and C infection requires comprehensive price reduction strategies for medicines, diagnostics and health commodities, including for those medicines and diagnostics in the development pipeline. Strategies include fostering generic competition, including through voluntary licences, and using the Agreement on Trade-Related Aspects of Intellectual Property Rights regarding flexibilities to protect public health. That would include compulsory licences and filing patent oppositions, differential pricing and direct price negotiations with manufacturers, as well as local manufacturing in accordance with the Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property, which also notes that intellectual property rights are an important incentive for the development of new health care products”. (Emphasis added.)
The last part of the sentence ‘intellectual property rights is an important incentive for the development of new health care products’, clearly aims to appease developed countries and the pharmaceutical transnational corporations.
While expressing unanimous support for the strategies many Member States pointed out that the high price of medicines is one of the main barriers against the successful achievement of the strategies. They particularly expressed their concern on the cost of hepatitis C treatment and requested capacity building and technical assistance from WHO to overcome price-related barriers. Concerns on high prices were not confined only to medicines. Member States also referred to prices on vaccines for hepatitis B and for HPV (human papillomavirus that causes cervical cancer) during their interventions on the global strategies.
During the discussions on the health sector strategies Timor Leste, on behalf of the South-East Asian Region (SEARO), observed that the cost of medicines for the treatment of hepatitis C such as Sofosbuvir is extremely high and that there is a lack of strategies to promote low cost generics in all countries afflicted with a high level of hepatitis C incidence. Timor Leste also noted that there is a need for scientific information for the introduction of HPV programs as there are large budget implications and that the national immunisation technical advisory groups should be strengthened for evidence-based decision.
China supported the progress made and noted that HIV is not just a public health issue but requires a multi-sectoral approach. It stressed that improvements in technical and financial support were needed. China also noted that there is a need to lower the prices of medicines.
Thailand pointed out that on viral hepatitis, a crucial challenge is the availability of hepatitis vaccines and that there is a need for a comprehensive package for treatment of viral hepatitis.
Saudi Arabia welcomed the strategies and emphasized their concerns regarding access to medicines especially vaccines. It also noted that steps to ensure access to generic medicines were not yet sufficient and called for the production of high quality generics for hepatitis infections as was with the case of AIDS.
Malaysia voiced its support for the strategies but pointed out that coverage cannot be reached if the medicines are very expensive and requested WHO to work on reducing prices with pharmaceutical companies.
Brazil also stressed that the high costs of medicines are threating the fight against STIs and hepatitis, emphasizing the importance of the use of TRIPS flexibilities.
India commended the Secretariat for the strategies and pointed out the importance of affordable HIV medicines and how India has played a key role at the global level. India also remarked on the importance of working on prevention and that the main challenge for the implementation of the strategies will be how to finance them.
Issues regarding prices of medicines were not only raised by developing countries, where this has been a long struggle, but they were also mentioned by developed countries such as Australia, the United Kingdom and Greece.
Australia welcomed the three strategies and highlighted that progress remains uneven. Further, Australia acknowledged that the challenges require Member States’ collaboration and welcomed the hepatitis strategy which recognizes the challenge of affordable access.
The United Kingdom emphasized the importance of country investment and called on the WHO to scale up country support to ensure universal coverage. Moreover, it noted that aiming to eliminate hepatitis by 2021 is an ambitious objective for countries to achieve considering the high cost of addressing the problem.
Greece remarked on its national efforts to develop a national hepatitis C plan and its commitment to ending viral hepatitis. However, Greece pointed out the moral dilemma it faced given the country’s resource constraints, and how that will be an obstacle for implementation. It noted that it will be important to have negotiations on the price of medicines according to national plans and to encourage tools like joint procurement and exchange of experiences across countries.
However, the United States noted that there is a need for more efficient delivery models and about information of how Member States will reach vulnerable groups. The US also noted that providing access to medicines is crucial but expressed concerns about WHO having an advocacy role to increase affordable access to medicines and the focus on prices and intellectual property in the strategies to increase access to hepatitis drugs.
At the adoption of the strategies by Member States the WHO Secretariat said that actions are now required for implementation and that there are major opportunities for comprehensive price reductions. It said further that price is a challenge and the introduction of generics is crucial for low and middle income countries and that now hepatitis C treatment has been produced for less than USD 300.
Discussions on challenges related to prices were also present at the adoption of the report of the Global Vaccines Action Plan (Document A69/34)where many Member States again expressed their concerns on the high prices of vaccines. Developing countries emphasized the difficulties in producing their own vaccines and the support needed from WHO to enhance capacity in vaccine manufacturing for countries to be able to keep high vaccination coverage.
Member States stressed that WHO should promote collective purchasing of vaccines and an emphasis was made on the need to use TRIPS flexibilities. Moreover, Member States raised important challenges in maintaining the immunization programs particularly for countries that are graduating or are not eligible for the Vaccine Alliance (GAVI) support. They highlighted the need to discuss a plan to reduce high vaccine prices and ensure the affordability of new vaccines.
Mirza Alas is a Research Associate of the South Centre and K M Gopakumar is a Legal Advisor of the Third World Network. This article also has inputs from the WHO Watch team of the People’s Health Movement.
This article was published in TWN Info Service on Health Issues on 11 June 2016.
Countries reaffirm need for high-level commitment on antimicrobial resistance
One year ago the World Health Assembly adopted a landmark Global Action Plan on anti-microbial resistance (AMR), which is now recognised as one of the gravest threats to public health. At the WHA in May 2016, participants took the opportunity to review the progress and challenges of implementing the Global Action Plan and to discuss recent developments and actions relating to AMR. This article reports on the AMR discussion at the 69th session of the World Health Assembly.
By Mirza Alas
Actions and challenges to implement the Global Action Plan on Antimicrobial Resistance gained attention at the 69th session of the World Health Assembly (WHA) that took place on 23-28 May.
Representatives from over 190 countries came to the World Health Organization’s headquarters in Geneva once again to participate in the annual meeting of the highest governing body of the World Health Organization (WHO). Over 3500 persons, including observers, participated at the week-long meeting.
There were long days with evening sessions to advance on more than 60 agenda topics. This 69th WHA represents a year since countries adopted the Global Action Plan (GAP) on Antimicrobial Resistance (AMR) and was thus an opportunity to assess progress, challenges and the way forward.
Under agenda item 14.4 on AMR (documents A69/24 and A69/24 Add 1) WHO Member States were provided with a short report on the progress of implementation of the GAP by regions, and the plans for a High Level Meeting at the side of the United Nations General Assembly in New York this coming September. There was also a document titled: “Options for establishing a global development and stewardship framework to support the development, control, distribution and appropriate use of new antimicrobial medicines, diagnostic tools, vaccines and other interventions” for discussion.
Countries noted the report of the implementation of the GAP and many of the Member States provided information on their respective national action plans’ (NAPs) implementation. Many countries acknowledged that much work still needs to be done and pointed out the importance of creating awareness of resistance at the national level as well as the urgent need for high-level political commitment on the issue that many hope can be addressed at the High Level Meeting in New York.
Countries also emphasized the need for inter-sectoral collaboration and the inclusion of not only ministries of health but also agriculture, environment and finance as well as the need for strong leadership from WHO and the importance of collaboration with the Food and Agriculture Organization (FAO) and the World Organization for Animal Health (OIE).
Developing countries stressed the need for financial and technical assistance as well as for capacity building. Access to vaccines and medicines were highlighted as key elements to ensure the successful implementation of the GAP.
Under the proposed options for a stewardship framework developing countries asserted the need to ensure that issues of access are balanced with appropriate use and scientific knowledge of the pursuit of the “One Health approach.”
Brazil in particular emphasized that the One Health approach could not be taken as a one-size fits all approach and that access and affordability must be at the forefront. Brazil also reaffirmed the importance of flexibilities of the Trade-related Aspects of Intellectual Property Rights Agreement (TRIPS) as a tool for countries to ensure access.
India called for policy coherence and that the principles of the Consultative Expert Working Group on Research and Development: Financing and Coordination (CEWG) are fully applied (affordability, effectiveness, efficiency, equity and de-linkage).
With regard to the High Level Meeting on AMR, India requested the WHO Director-General to recommend that AMR be addressed as a global development issue, that awareness must be created and to ensure that any stewardship framework integrates sustainable and equitable access (to antibiotics and other related medicines and diagnostics).
Iran requested that a consultative meeting be conducted by WHO to clarify expectations around the UN High Level Meeting.
Zimbabwe on behalf of the African region asked the secretariat to prepare a document on how prioritization of antibiotics could work and the repercussions that this could present.
Developed countries reaffirmed AMR as a global health security issue and their commitment to the High Level Meeting.
The United Kingdom noted that the Fleming fund, with £195 million, has been established to build capacity for low and middle-income countries, and called for engagement with other UN bodies such as FAO and also the World Trade Organization.
The United States stressed that AMR threatens health and economic potential at all levels and supported the global development and stewardship framework, noting that the framework should explore innovative arrangements and bring the private sector to the table. It also expressed concerns over the UN High Level Panel on Access to Medicines convened by the UN General-Secretary and asked to delete any reference to it in the text of the possible framework.
[A letter from 6 major industry associations to Senator Orrin Hatch, chair of the US Senate Committee on Finance, dated 18 February 2016 expressed strong criticism over the UN High Level Panel on Access to Medicines. The Panel formed in November 2015 is tasked to analyse and make recommendations to “remedy the policy incoherence between the justifiable rights of inventors, international human rights law, trade rules and public health in the context of health technologies”.
[The signatories were the Biotechnology Innovation Organization (BIO), National Association of Manufacturers (NAM), National Foreign Trade Council (NFTC), the Pharmaceutical Research and Manufacturers of America (PhRMA), the US Chamber of Commerce (the Chamber), and the United States Council for International Business (USCIB).
[The letter claimed that, “the UNHLP process will not provide for an informed, balanced, and inclusive dialogue that adequately incorporates the perspectives of innovators.” The US lobbies also criticised work done by the WHO on its Framework of Engagement with Non-State Actors (FENSA) as well as in the UN’s global Technology Facilitation Mechanism.
[According to a 6 April 2016 report in the South-North Development Monitor (SUNS), “the American business lobbies are on a warpath because the panel includes a range of people with different backgrounds and experiences and it might adopt a genuine inquiry into the policy incoherence that is responsible for denying humanitarian remedies … Casting aspersions on the selection process of the panel, the business lobbies raised vicious charges that the panel will not be able to assess ‘the complex issues impacting the development and deployment of health-related technologies.’” For the full article, see US business launches campaign against UNHLP.]
Italy emphasized that the pharmaceutical sector and regulatory agencies should be included in the debate and that the G7 and G20 initiatives on AMR can strengthen WHO’s initiatives.
Sweden remarked that the UN High Level Meeting will be a unique opportunity for political level support and that all sectors need to be involved and be part of the 2030 Agenda on Sustainable Development (and its Sustainable Development Goals).
After Member State interventions, Mr. Keiji Fukuda, WHO Assistant Director-General and Special Representative for Antimicrobial Resistance, emphasized that the challenge is clear and that AMR will have a direct impact on agriculture and food production, noting the concerns on development, access and the relationship with Sustainable Development Goals.
Fukuda said that the challenge is to keep the impact on health central in this response. It is clear we also have to engage with other stakeholders, ministries of health, trade, industry and pharma and create a multisectoral response.
On the One Health approach, he said that this is done for good reason as the connections between the sectors are close. WHO works closely with FAO and OIE and Member States have repeatedly mentioned working with those two organizations. Fukuda recognized that there is a need to be coordinating with other initiatives such as Codex Alimentarius.
On how to move forward he stressed three essential elements:
GAP is the technical blueprint, and covers many of the issues talked about at the WHA discussion, including preservation, access, prevention, etc. We have the key action and countries to develop and implement NAPs.
Moving ahead with the options for the global development and stewardship framework – many inputs from countries are needed now. At this point several countries believe a process is needed to take this forward and to take it to the WHO Executive Board and report back.
Need for high-level political engagement – the New York meeting is critical for high level engagement needed so we can move ahead and the meeting should be the start.
On the UN High Level Panel on Access to Medicines, Fukuda acknowledged the point made by the US that the outcome of the panel was not yet known.
Fukuda told Third World Network (TWN) separately that the New York meeting will be an opportunity to get political commitment to reaffirm the importance of the GAP adopted by the WHA last year.
(TWN also learnt from a source that, discussions on the framework of stewardship will likely start in the coming months or probably after the UN High Level Meeting in New York.)
Meanwhile negotiations began in New York this June on an outcome document and it is important that missions in Geneva are able to coordinate with their counterparts in New York for an outcome that provides strength and traction for the full implementation of the GAP and to ensure that developing countries can get the financial and technical resources they will need to truly tackle this global problem. As can be seen from the WHA discussion, most developing countries are keen that access remains at the forefront of any political declaration.
Below a summary of selected interventions by Member States and their groupings:
Thailand on behalf of the South East Asian Region (SEARO) expressed its support to the High Level Meeting at the at UN and said that a global political commitment will lead to sustainable multi-sectorial commitment but resources are needed to tackle the challenge.
Antibiotic prioritization and the capacity of different countries have to be taken into account. There is a real need for an effective global mechanism and tools to make sure that every Member State can walk the talk of addressing AMR. The role of pharma in the stewardship framework, especially in rational use, needs to be revisited, Thailand said, adding that promotional activities by pharma influence prescriber behavior.
Zimbabwe on behalf of the African Region (AFRO) said the threat of AMR should be viewed as a development issue. WHO should support implementation especially to the development of national actions plans, including training of health workers, surveillance, building regulatory capacities that are currently weak, and also capacity in laboratories that is now inadequate. The agricultural sector remains an important sector, stressed AFRO. It supported convening the High Level Meeting in New York to increase awareness and political commitment.
Zimbabwe also said that further discussions are needed on the three elements of the Global Stewardship Framework. The principle of access to new and existing antibiotics and diagnostics needs to be reflected, and burden of disease should be taken on board so as not to exacerbate the problem of shortage of medicines.
It requested the Secretariat to prepare a document on how prioritization of antibiotics could work and the repercussions.
Iraq said that WHO has a role in supporting countries, capacity building and joint monitoring and should be involved in formulating action plans.
Kenya aligned with the statement of AFRO and acknowledged the burden that AMR imposes. It also reiterated the need for political, financial and technical support from WHO and other partners. The fight against AMR calls for an inter-sectoral approach, thus Kenya is addressing it together with its ministries of agriculture and health. In addition, a technical working group in Kenya is drafting a national action plan.
Kenya took note of the stewardship framework, stressing that it is important to ensure the involvement of Member States and relevant stakeholders in such a framework. It also called for development and implementation of surveillance systems and fostering of collaboration and information sharing.
South Africa aligned with AFRO and noted that the global development and stewardship framework was recommended with the aim of stewardship and access to antibiotics and therefore it is important to balance the issues of access, appropriate use, scientific knowledge and the elements of the One Health approach, agriculture and environment.
It called for focus on unnecessary use, and the need to review the WHO essential medicines list. It cited restricted use of second line antimicrobials and limited use in cases where failure of the first line of antibiotics has been confirmed.
Brazil said AMR deserves serious consideration. In Brazil mandatory prescriptions of antibiotics have been put in place but this is not the case in all countries. It said that action is needed to not duplicate the gaps in AMR, adding that the One Health approach is not a one-size fits all approach and there is need to work within the framework and mandate. Brazil also stressed the need for access and affordability where antibiotics are required, together with innovation, saying further that TRIPs flexibilities should be affirmed as a tool to allow early access to antibiotics in the market.
Egypt reaffirmed its commitment and inquired about the fair access to antibiotics and essential medicines for developing countries in the light of resistance. It also stressed the need for the WHO Essential Medicines List to be regularly updated. There is need to support capacity building in microbiology laboratories and WHO to support developing countries for technology capacity and financial support.
India noted the report of the Secretariat on the options for establishing a global development and stewardship framework on AMR. Promoting affordable access has been discussed in paragraphs 28-31. While appreciating the options delineated to promote affordable access, India said concrete action is expected through the AMR framework in consonance with the mandate given by WHA resolution 68.7. In this context it is important that the principles of the CEWG are fully applied and that policy coherence is reflected in WHO’s action.
India looks forward to the high-level meeting on AMR in New York in September 2016. This meeting will certainly heighten attention of all countries for prevention and containment of AMR, it said, adding that the success of the GAP hinges on its effective implementation by all countries. However, for many countries AMR is also a formidable development challenge, said India, and it requested the Director-General to make the following recommendations to the High Level Meeting:
Recognize and address AMR as a global development issue;
Focus on awareness on AMR including through the launch of an AMR logo;
Integrate sustainable and equitable access in the global development and stewardship framework.
Iran remarked on the importance to ensure that patients have access to high quality antibiotics. It requested the secretariat to hold a consultative meeting to clarify expectations around the UN High Level Meeting. It also highlighted the need to consider incentives such as research grants and data sharing between countries. Iran said that a key strategy is international monitoring of antibiotics to ensure access to quality antibiotics, adding also international awards for doctors who properly prescribe antibiotics.
The Netherlands speaking on behalf of the European Union (EU) said that the GAP references well the One Health approach. It noted more concrete progress towards a global framework (including making a list of priorities in antibiotics) and remarkably good collaboration with FAO and OIE, adding that there is need for active preparation and coordination of Member States.
The United Kingdom supported the Netherlands’ statement on behalf of the EU, and indicated that it was happy with the report, and that more should be done and more can be done at the UN General assembly High Level Meeting. Development of NAPs was welcomed and it said countries should start to develop them and publish them by September if possible. The UK called for building on commitments including in the G20.
It further said that it has plans to address current market failures and mentioned the commitment of £195 million in the Fleming fund to build laboratory capacity for low and middle-income countries. The global development and stewardship framework will support the work of other governing bodies; however there is a need to define its scope. The UK also stressed engagement with other UN bodies such as FAO, WTO as the framework moves forward.
Germany welcomed the support provided by WHO for countries to develop NAPs. It will contribute euros 1.3 million for implementation of the GAP, but each Member State has to contribute by developing their own NAP. Germany strongly supported the leadership of the WHO and encouraged discussions to be taken up to a higher political level at the UN High Level Meeting in New York. It is supporting the initiative of WHO-DNDi with euros 500,000 this year, and encouraged other countries to also contribute.
The United States said the tripartite collaboration (of WHO, FAO and OIE) is critical for the One Health approach and that AMR threatens health and economic potential at all levels. It supported the global development and stewardship framework; highlighted innovative arrangements and bringing the private sector to the table as their actions are critical. Human, animal, environment, food and industry sectors should be involved, said the US.
It also said that like the WHO Essential Medicines List, the OIE could have a list of antibiotics for animal use for the framework. Proper manufacturing and proper use in human and animals was noted by the US.
It asked for deletion of any reference to the UN High Level Panel on Access to Medicines due to its concerns with this panel.
Sweden noted that the WHA discussion was a good start and that the UN High Level Meeting (in New York) will be a unique opportunity for political level. All sectors need to be involved and be part of the 2030 Agenda for Sustainable Development. It requested the Director-General to continue engaging with the UN for a strong outcome of the High Level Meeting and to report to the 140th session of the WHO Executive Board on the progress made and proposals of how to take the process forward. Sweden has itself adopted a strategy to combat AMR.
Italy said the One Health approach is the pillar of Italy’s national health service. Veterinary and food chain sectors are fairly advanced. There are critical problems of over prescription by doctors, self-prescription by patients and trade in fake medicines. The pharmaceutical sector and regulatory agencies should be included in the debate, it said, adding that G7 and G20 initiatives on AMR can strengthen WHO’s initiatives.
Japan said AMR is a threat to global health security and that WHO should continue to engage with the UN Secretary-General regarding the High Level Meeting. WHO should also continue working on the Global Development and Stewardship Framework, and the modalities of the framework should be based on each country’s context.
Medicus Mundi International – International Organisation for Cooperation in Health Care (MMI) made a statement on its own behalf and that of 20 other civil society organisations (CSOs) including many members of the Antibiotic Resistance Coalition.
MMI said that the extensive misuse of antimicrobials in humans and animals have raised levels of resistance posing a global health threat that jeopardizes treatment of infections across the world. Public leadership is needed to enact new needs-driven research and development models, with open research and transparent data which support rational use and equitable access to antibiotics.
It stressed the importance to ensure coherence across parallel processes addressing innovation and access — the CEWG on R&D, the R&D Blueprint for Emergencies and the UN High Level Panel on Access to Medicines.
The CSO statement urged WHO to apply the CEWG principles of affordability, effectiveness, efficiency, equity and de-linkage to any initiative based on publicly-funded R&D. It pointed out that the pharmaceutical companies distort de-linkage to mean an assured return for industry irrespective of the value of the innovation in promoting public health goals.
Proposals should also address innovation of vaccines and diagnostics, said MMI, adding that securing access for everyone in need is as vital as conserving therapies. Price should not be used as an instrument to ration use for humans, it said.
The CSO statement also stressed that strengthening of public health and agricultural systems across all countries is a key requirement. Resource-limited settings need support to strengthen infection prevention and control. Sustained investments to address AMR across sectors must become a collective commitment.
With resistance now evident to last line antimicrobials it is urgent that Member States and WHO act decisively, said MMI. “We urge WHO to take a leadership role both here as well as in New York as preparations for upcoming UN High-Level Meeting on AMR continue. We ask that WHO, Member States, and other intergovernmental agencies ensure that AMR becomes a remarkable example of intersectoral coordination that puts the public interest at the center of its discussion.”
Mirza Alas is a Research Associate of the South Centre. This article also has inputs from, and was edited by Chee Yoke Ling, Director of the Third World Network.
This article was published in TWN Info Service on Health Issues on 30 May 2016.
South Centre and G-15 strengthen cooperation
A Memorandum of Understanding (MOU) was signed between the South Centre and the Group of 15 Secretariats in Geneva on 16 June 2016.
The signing of the MoU of cooperation between the South Centre and the G-15 Secretariats is intended to promote the work of both institutions in the strengthening of the capacity of developing countries to better articulate their interests and perspectives in multilateral, regional and national forums.
The cooperation agreement includes key areas and actions such as mutual assistance in capacity building activities, organization of joint workshops, symposia training sessions on thematic issues, joint publications and summing efforts to enhance opportunities for South-South cooperation.
Speaking after the ceremony of signature of the MoU, H.E. Ambassador Ravinatha Aryasinha, Chairman of the Personal Representatives of the Heads of State and Government of the Group of Fifteen and the Permanent Representative of Sri Lanka to the United Nations in Geneva, said that the MoU formalizes the cooperation already achieved by the two institutions, recalling that there has been successful outcomes of the briefings on SDGs, Post-2015 and Agenda 2030 jointly organized most recently and with high attendance by the Geneva based delegations and experts of international organizations. With the MoU, “there are now expectations of greater activities which will benefit both, member states of the two organizations and the entire Global South,” he said.
Executive Director of the South Centre, Mr. Martin Khor, recalled that both organizations have similar history and that they have been moving along in parallel tracks since their birth until now. The Executive Director of the South Centre said that the MoU is a step forward for both Secretariats in further promoting South-South cooperation. Developing countries’ delegates “need research, they need to get together to identify what their positions are in international relations, and share their experiences at international level with regard to their development policies,” said Mr. Khor.
Human Rights Council adopts historic resolutions on access to medicines
The Human Rights Council adopted by consensus two important resolutions reaffirming that access to medicines and enhancing capacity building in public health are fundamental elements for achieving the full realization of the right to health. Members agreed to hold panel discussions during the next sessions. A panel discussion on access to medicines will be held at the 34th session of the Human Rights Council in March 2017. A panel discussion on enhancing capacity-building in public health will be held at the 35th session of the Human Rights Council in June 2017.
By Adriano José Timossi and Viviana Muñoz-Tellez
The 32nd session of the Human Rights Council was held in June/July in Geneva. In what constitutes a historic event for the health and public rights agenda, two resolutions were adopted by consensus.
The draft resolution 32/L.23 entitled “Access to medicines in the context of the right of everyone to the enjoyment of the highest attainable standard of physical and mental health” was tabled by Brazil, China, Egypt, India, Indonesia, Senegal, South Africa and Thailand. The resolution was also supported by 72 cosponsors.
As one of main outcomes, the resolution decided to convene at its thirty-fourth session, a panel discussion to exchange views on good practices and key challenges relevant to access to medicines as one of the fundamental elements of the right of everyone to the enjoyment of the highest attainable standard of physical and mental health, taking into account all relevant reports, and that the discussion shall be fully accessible to persons with disabilities.
This panel will be an opportunity also to debate the outcomes of the work of the High Level Panel established by the UN Secretary General which outcomes are to be presented in the coming months. In adopting this resolution by consensus, Member States of the Human Rights Council have agreed to advance access to medicines as a key priority in the context of progressive realization of the right to health.
During the past 10 years the Human Rights Council has considered the issue of access to medicines through different initiatives in resolutions and reports. The last resolution 23/14 in 2013 was adopted by a vote of 31 in favour to 0 against, with 16 abstentions. The current approval by consensus brings back a good spirit of work of the Human Rights Council on this issue which contributes to advance the agenda on access to medicines.
It is also a timely moment to bring back the issue to the Council, taking into account recent developments in other fora and the need for continued debate and discussion on best practices to uphold the primacy of human rights, including the right to health, over trade, intellectual property rights and other economic agreements and interests. Importantly, the resolution reaffirms the ability of countries to use the flexibilities available under the WTO agreement on trade related aspects of intellectual property rights to promote access to medicines, in recognition that patents can be used to set high prices for medicines.
A new momentum to promote access to medicines has been created with the adoption of the 2030 Agenda and the Sustainable Development Goal 3 on Health and the 2015 edition of the Social Forum on “Access to medicines in the context of the right to health”. It also builds upon these recent developments and previous resolutions adopted at the Council and the ongoing work of the Special Rapporteur on the Right to Health and recently established UN Secretary General’s High Level Panel on Access to Medicines.
The resolution reaffirms the need for access to affordable, safe, efficacious and quality medicines for all as a primary human right and underscores that improving such access could save millions of lives every year. The resolution also calls upon Member States and other stakeholders to create favourable conditions at the national, regional and international levels to ensure the full and effective enjoyment of the right of everyone to the highest attainable standard of physical and mental health.
The resolution also recalled that the Doha Ministerial Declaration on the Agreement on Trade-Related Aspects of Intellectual Property Rights and Public Health confirms that the Agreement does not and should not prevent members of the World Trade Organization from taking measures to protect public health. It also called upon States to promote access to medicines for all, including through the use, to the full, of the provisions of the Agreement on Trade-Related Aspects of Intellectual Property Rights which provide flexibility for that purpose, recognizing that the protection of intellectual property is important for the development of new medicines, as well as the concerns about its effects on prices.
Ambassador Regina Maria Cordeiro Dunlop of the Permanent Mission of Brazil to the United Nations in Geneva introduced the draft resolution on behalf of the core group. Amb. Dunlop recalled that for millions of people throughout the world the full enjoyment of the human right to health still remains an elusive goal. According to the WHO, at least one third of the world’s population has no regular access to medicines. No effort should be spared to realize this right for all. Health is a fundamental human right, indispensable to the enjoyment of many other human rights and necessary for living a life in dignity.
Amb. Dunlop also explained that the resolution aimed at reaffirming access to medicines as a fundamental element in the realization of the right of everyone to the enjoyment of the highest attainable standard of physical and mental health, and noted the support and engagement of all delegations during the informal consultations and constructive contributions that helped to pave the way toward a common understanding on access to medicines as a fundamental element of the right to health.
Ambassador Ajit Kumar, Permanent Representative of India to the UN in Geneva, also made a statement as a member of the core group of the resolution on access to medicines. Amb. Kumar noted that challenges of access to medicines are no longer limited to developing countries or to the so-called neglected diseases. It is effecting people in the global North as well, stretching the health budgets of all governments and impacting treatment to common diseases like hepatitis and cancer.
Amb. Kumar also noted that the existing global framework does not allow the fruits of medical innovation to be equitably shared, in particular to those who are in most need of them, and the innovation models that thrive on the current system have failed to address the health R&D needs of developing countries. This is evident from the lack of any new medicines and vaccines for long known infectious diseases like TB and Malaria, which continue to take a huge public health toll.
Amb. Kumar further noted that the Human Rights Council has made some seminal contributions in recognizing access to medicines as a fundamental component of the right to health. A number of Council resolutions have reaffirmed the right of Member States to give primacy to public health over trade and intellectual property considerations as enshrined in the Doha Declaration on Public Health and TRIPS Agreement. Despite this, the barriers to the full use of TRIPS flexibilities have only increased. The trend to impose TRIPS plus standards further threatens the full realization of the right to health of millions of people by placing further obstacles to access to medicines.
Amb. Kumar stated that there is a need to once again place the human rights dimensions of access to medicines at the centre of efforts to create favorable conditions at the national, regional and international levels to ensure the full realization of the right to health and the health related goals of Agenda 2030. The current draft resolution builds on the previous Council resolutions on the topic.
Amb. Kumar noted that the resolution appreciates the establishment of the High Level Panel on Access to Medicines by the UN Secretary General with the mandate to address policy incoherence in public health, trade, the justifiable rights of inventors and human rights in the context of access to medicines and innovation, and noted that the Office of the High Commissioner has participated actively in the expert advisory group supporting the High Level Panel. Accordingly, Amb. Kumar stated that it would be a timely opportunity for the Council to take into account recent developments and have a constructive discussion on how Member States and other stakeholders can overcome some of the persistent barriers to access to medicines, and achieve the much needed policy coherence in the area of human rights, intellectual property, trade and investment policies by reaffirming the importance of human rights when considering access to medicines.
A second draft resolution 32/L.24 entitled “Promoting the right of everyone to the enjoyment of the highest attainable standard of physical and mental health through enhancing capacity-building in public health” was also adopted by consensus. It recognizes the need for strengthening capacity building for public health and was introduced by China with numerous co-sponsors.
The resolution reaffirms that strengthening public health is critical to the development of all Member States, and that economic and social development are enhanced through measures that strengthen capacity-building in public health, including training, recruitment and retention of sufficient public health personnel, and systems of prevention of and immunization against infectious diseases.
The resolution also recognizes the importance of substantially increasing health financing and the recruitment, development, training and retention of the health workforce in developing countries, especially in least developed countries, small island developing States and landlocked developing countries.
The resolution provides that a panel discussion will be held with the participation of States, relevant United Nations agencies, funds and programmes, academics and experts and non-governmental organizations, with the objective of exchanging experiences and practices on realizing the right of everyone to the enjoyment of the highest attainable standard of physical and mental health by enhancing capacity-building in public health. The High Commissioner is tasked to prepare a summary report on the panel discussion and to submit it to the Human Rights Council at its thirty-sixth session.
Both resolutions also welcomed the 2030 Agenda for Sustainable Development, including its Goal 3, which highlights the importance of ensuring healthy lives and promoting well-being for all at all ages, and recalled in that regard the adoption on 28 May 2016 by the World Health Assembly of its resolution WHA69.15 entitled “Health in the 2030 Agenda for Sustainable Development”. Member States also welcomed efforts of the World Health Organization, in cooperation with Member States, in enhancing capacity-building in global public health and in meeting the targets specified in Sustainable Development Goal 3.
The two resolutions adopted by consensus comes at a good time when the celebrations of the 30th Anniversary of the Declaration on the Right to Development are taking place, a declaration in which the right to health is recognized as well as access to medicines and public health as key elements for realizing the Right to Development.
Adriano José Timossi is Senior Programme Officer of the Global Governance for Development Programme (GGDP) and Viviana Muñoz-Tellez is the Programme Coordinator of the Development, Innovation and Intellectual Property Programme (DIIP) of the South Centre.
Patents and Public Health: Exploring Options for Future Work in the WIPO
The South Centre organized a side event to the 24th session of the WIPO Standing Committee on the Law of Patents. The panel discussed options for future work in WIPO on patents and public health. Below is a report of the event.
By Viviana Muñoz-Tellez
The South Centre organized a side event to the Twenty-Fourth Session of the World Intellectual Property Organization Standing Committee on the Law of Patents (SCP) on 29 June 2016 at the WIPO headquarters in Geneva. The panel discussed options for future work in WIPO on patents and public health. The SCP is a relevant forum for the discussion in the context of the international patents system and its relation to meeting the public policy objective of ensuring access to medicines for all. The panel discussed how this policy objective can be achieved, in compliance with the World Trade Organization Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) and the Doha Declaration on TRIPS and Public Health.
The Chair of the panel, Dr. Viviana Muñoz Tellez, Coordinator of the Development, Innovation and Intellectual Property Programme (DIIP) of the South Centre, began the discussion by saying that the WIPO SCP is in the process of defining its future work plan. A balanced work plan should include the issue of public health and patents. WIPO as a specialized agency of the United Nations is mandated to contribute to the achievement of the Sustainable Development Goals, including SDG 3 on health. The complex interlinkages around issues of public health, intellectual property, innovation and building local industrial capacity, trade and human rights are being discussed in a number of multilateral fora. The SDGs are the framework to seek greater policy coherence. The WIPO Secretariat has undertaken initiatives on intellectual property and public health, including cooperation with WHO and WTO, publications and s