Info Service on Health Issues (Jan15/04)
WHO: Critical issues still unresolved in antimicrobial resistance draft action plan
Geneva, 28 January (Mirza Alas) – Several critical issues remain unresolved in a draft global plan to put in place a sustained public health response to antimicrobial resistance.
The severe state of antimicrobial resistance with no effective antibiotics in sight and its alarming impact on public health worldwide has prompted World Health Organization Director General Dr. Margaret Chan to warn that inaction would mean “the end of modern medicine as we know it”.
However, several health experts and practitioners say that the draft Global Action Plan (GAP) on Antimicrobial Resistance prepared by the WHO Secretariat, following several consultations with Member States and the wider health community and civil society groups, still needs considerable improvement.
The critical issues are: access to current and new antibiotics, research and development of new antibiotics and diagnostic tools, rational use of antimcrobial medicines, regulation of promotion and marketing of medicines, as well as financial and technical assistance for developing countries for the implementation of GAP.
The draft GAP is high on the agenda at the 136th Executive Board (EB) that is meeting from 26 January to 3 February at the WHO headquarters in Geneva. It will be discussed today (28 January) under Agenda item 8.1 (For the text of the draft plan please see: http://apps.who.int/gb/ebwha/pdf_files/EB136/B136_20-en.pdf).
Stressing the importance of the issue, DG Dr. Margaret Chan in her opening remarks at the EB session on 26 January had highlighted some of the dangers of antimicrobial resistance.
She stressed that, “Resistance to antimicrobial medicines is happening in all parts of the world for an increasingly broad range of pathogens. The consequences for human health are severe, especially with so few replacement products in the pipeline. The world is moving towards a post-antibiotic era in which many common infectious diseases may once again kill. In the absence of effective antibiotics, some of the most advanced interventions available to modern medicine, like organ transplantations, hip and joint replacements, cancer chemotherapy, and care of pre-term infants, could become too dangerous to perform. The consequences can be succinctly expressed: the end of modern medicine as we know it.”
In light of the severity of antimicrobial resistance, political momentum to act culminated in a decision of the 67th World Health Assembly in 2014 to mandate WHO to prepare the GAP. Resolution WHA67.25 requested the Director General (DG) “to develop a draft global action plan to combat antimicrobial resistance, including antibiotic resistance, which addresses the need to ensure that all countries, especially low- and middle- income countries, have the capacity to combat antimicrobial resistance and …”(http://www.twn.my/title2/health.info/2014/hi140506.htm)
The Secretariat prepared the draft GAP based on the inputs from various consultations that it either organized or participated in, including the WHO Strategic Technical Advisory Group (STAG) on antimicrobial resistance, regional and country meetings, high-level technical, political and interagency discussions and a web-based consultation. In late October 2013 a Member State consultation was organized to obtain feedback from Member States on the initial draft of GAP (http://www.twn.my/title2/health.info/2014/hi141003.htm).
The latest version of GAP tabled for the EB discussion contains four parts: an introduction outlining the issue, the scope, the challenge, and a proposal for the way forward. The last part includes a table with actions outlined for Member States, the Secretariat and for international and national partners underpinned by the main objectives explained below.
The draft GAP frames the overall goal as: “to ensure, for as long as possible, continuity of successful treatment and prevention of infectious diseases with effective and safe medicines that are quality-assured, used in a responsible way, and accessible to all who need them.” Together with this main goal GAP also contains the following five guiding principles:
These principles draw the main lines of the plan ensuring the engagement of all actors, guaranteeing prevention as an important strategy and cost effectiveness. The third principle aims to ensure “equitable access and appropriate use”. The last two principles looked at sustaining actions in systems and practices and builds on the fact that countries are at different stages in designing and implementing antimicrobial action plans and therefore some flexibilities need to be built in for those countries.
Moreover, the draft GAP also outlines the following five objectives that are meant to support the actions needed to address antimicrobial resistance:
The draft GAP addresses many of the considerations put forward by Member States and civil society organizations. For instance, it provides a good perspective on the complexities of antimicrobial resistance and the need for creating awareness at all levels of society and incorporating this component in professional education and training. The plan also incorporates actions for other UN agencies to work on that will complement the work of the WHO.
Some concerns and shortcomings
However, draft GAP is either silent or soft on certain critical issues that are important to address antimicrobial resistance in a comprehensive manner, especially in the developing country context.
The strategic objectives do not give sufficient recognition to equitable and affordable access to existing and new antibiotics especially for developing countries and poor and vulnerable sections of society. Instead of giving due concern to affordable access, the draft GAP in formulating the principle of “access not excess” can inadvertently convey a meaning that affordable access may lead to excess and therefore needs to be checked.
Another important concern of is GAP’s silence on the question of financial and technical assistance to developing countries for operationalizing the action plan. Paragraph 50 of the draft GAP states: “Member States are urged to develop their own national action plans on antimicrobial resistance within the next two years of the endorsement of the draft action plan by the Health Assembly that are in line with the global action plan”. However, GAP does not provide any indication on how developing countries are expected to obtain resources to implement national plans national strategies and surveillance systems.
The issue of research and development (R&D) of new antibiotics is still not really addressed in the current draft. Objective 5 mentions how most pharmaceutical companies have stopped researching on new antibiotics and how “the cost of investment in research and development may need to be de-linked from the volume of sales.” However, under the actions of this Objective Member States are encouraged in the “strengthening existing and creating new public-private partnerships for encouraging research and development of new antimicrobials agents and diagnostics.”
Furthermore the Secretariat is to “explore with Member States, intergovernmental organizations, industry associations and other stakeholders, options for the establishment of a new partnership or partnerships”.
While “delinking” is raised, the emphasis and recommendation is on creation of new public-private partnerships. There is no mention, as a way forward, the new R&D model based on delinking of cost of R&D from the price of a product as proposed by WHO’s own Consultative Expert Working Group on Research and Development: Financing and Coordination.
The draft GAP continues to remain weak on the crucial aspect of regulation of promotion and marketing of antibiotics.
Paragraph 42 states that “industry’s spending on promoting products is greater than governmental investment in promoting rational use of antimicrobial medicines or providing objective information”. However, the indicated actions under Objective 4 do not include any regulation of unethical promotion of medicines. This is despite the fact that in recent years pharmaceutical transnational corporations such as Glaxo Smithkline (GSK) and Novartis faced or are facing prosecution/investigations in the USA, Japan, China and Poland for unethical promotion of medicines.
Furthermore, the WHO Global Strategy on the Containment of Antimicrobial Resistance (http://www.who.int/drugresistance/WHO_Global_Strategy_English.pdf) clearly calls for the adherence to national and international codes of practices on promotional activities. Even this clear language on codes of practices (not regulation) is missing in the draft GAP.
Instead, the indicated actions in the draft GP are: identification and elimination of economic incentives in all sectors that encourage inappropriate use of antimicrobial agents and introduction of incentives to optimize the use. Further, the draft GAP proposes “effective and enforceable regulation and governance to ensure appropriate licensing, distribution, use and quality assurance of antimicrobial medicines in human and animal health, including a regulatory framework for preservation of new antibiotics”.
The soft approach on unethical promotion of medicines including antibiotics could be due to the approach of GAP for implementation through a partnership model and the creation of new public private partnership for R&D.
Another area of concern is that the current language in the draft GAP, particularly paragraph 17, makes a problematic reference to Substandard/Spurious/Falsely labeled/Falsified/Counterfeit (SSFFC) medicines as one of the causes of antimicrobial resistance.
The problem of lack of active ingredients or inadequate dosage is a problem of quality, safety and efficacy (QSE) of a medicine. Paragraph 44 of the draft GAP cites the prevalence of substandard medicines for both human and veterinary use as a cause for developing antimicrobial resistance. Accordingly an indicated action identified for the Secretariat under Objective is to “Provide support to Member States in the development and enforcement of relevant regulations that will prevent substandard/spurious/falsely -labelled/falsified/ counterfeit antimicrobial medical products reaching patients”.
However, the word ‘counterfeit’ refers to a particular type of intellectual property (IP) infringement and links the issue of QSE with such infringement. The pharmaceutical transnational corporations conflate the issue of QSE of medicines with IP rights such as counterfeit in order to push for IP enforcement. The issue of quality of antimicrobial medicines should be addressed through measures that are appropriate to national circumstance without linking it to IP.
In addition, the draft GAP should also address affordable access to QSE medicines and rational use of drugs, instead of linking to the question of SSFFC as in the draft now. To date there is no shared understanding on the term SSFFC. A Member State-driven process is discussing the issue of SSFFC (http://apps.who.int/gb/ebwha/pdf_files/EB136/B136_29-en.pdf) and the outcome of that process should not be pre-judged. Therefore, the GAP should remove any reference to SSFFC.
Another problematic area could be the indicated action Member States action under Objective 5. It suggests: “Collaborating in the investigation of natural resources of biodiversity and bio repositories as sources for the development of new antibiotics”. However, the document does not mention the obligations under the Convention of Biological Diversity and its Nagoya Protocol that create an obligation to fairly and equitably share the benefit of such research as a condition to access bio resources.
According to an observer at the ongoing EB session, the draft GAP follows a health security approach rather than a health system approach.+
(With inputs from K M Gopakumar and edited by Chee Yoke Ling)