International Insulin Foundation c/o Liverpool School of Tropical Medicine Att: Professor G. Gill Pembroke Place Liverpool L3 5QA United Kingdom e-mail: [email protected]; [email protected] 13 February, 2016 Dear Madam, Dear Sir, International Insulin Foundation comments on the World Health Organization’s Discussion paper: Essential medicines and basic health technologies for noncommunicable diseases As an NGO in official relations with the World Health Organization (WHO) the International Insulin Foundation (IIF) would like to thank the WHO for the opportunity to be able to comment on the important paper entitled “Essential medicines and basic health technologies for non-communicable diseases”. The IIF, as you know, has been active since 2002 in the area of access to insulin and diabetes care in the world’s poorest countries and applauds the WHO on this important document, which can truly serve as a guide to improving access to essential medicines for diabetes and other non-communicable diseases (NCD). We would like to make the following general and more specific comments. General comments: - First and foremost we need a definition of what the 80% target really means. For example for someone with type 1 diabetes, not having access to insulin 20% of the time or in 20% of facilities, may equal a death sentence. Also, how will affordability be defined within the 80% target? - The issue of why people with diabetes or cardiovascular disease are at risk from catastrophic health expenditure is hardly covered. Pharmaceutical companies promoting the latest and the best to the private physicians, who then prescribe it to all their patients, is an issue that needs to be included. - Sulphonylureas should be included (probably gliclazide) in the essential list of drugs on page 7 paragraph 7 (for diabetes, only metformin and insulin are included). Sulphonylureas have some bad press and declining use in resource-rich countries, but in the tropics are very useful in combination with metformin (and in gestational diabetes), delaying the need for insulin; thereby conserving supplies of this scarce and vital drug. Specific comments: - On page 8 - yes research is needed, but this needs to be put into a wider context. For NCDs (maybe minus cancer) we have effective treatments, and the problem is that these are not reaching individuals. If a new hypertension medicine comes onto the market, or if a vaccine for the prevention of type 1 diabetes is found, these will not reach the poorest of the poor and all the gap between the have and have-nots increases. - On page 9 - the sentence: “The necessary level of coordination to realize the much-needed, whole-of-government, multisectoral and intersectoral action is absent in many countries.” Yes multi-stakeholder roles can be present, but at the end of the day this is the role of the health system, Ministry of Health, and government. - In Table 1: o Move the first bullet “Issues with the poor use of health technology assessment in decision-making for procurement of medicines” to the end o Delete last bullet - “Poor acceptability by patients leading to lack of adherence” - no evidence of this “High prices due to existing intellectual property rights for medicines still under patent” is only relevant for cancer medicines? o Add to “Sustainable financing” the issue of lack of donor support o Delete - “Poor use of risk pooling and sharing mechanisms” - not sure what this means and how it is relevant o Poor choice of word in “Hampered capacity for local manufacturing, especially in low- and middle-income countries” - the word hampered should be changed. Some countries do not have the capacity to produce medicines locally. The same is true for many products, and this is not an issue of hampered capacity. On page 11 the sentence “Information asymmetry and bias also create problems for pricing structures” is unclear as is the use of the word bias On page 11 a better link needs to be established between the sentence “According to data from the IMS Institute for Healthcare Informatics report on the Global Outlook for Medicines through 2018, developing countries (excluding pharmerging countries) accounted for approximately 12% of global spending on all medicines” and “This has implications for equity, as low- and middleincome countries bear a significantly disproportionate burden of both communicable and non communicable diseases.” Point 17 on page 12 - the link between human rights and access to medicines is poorly described. This either needs to be reinforced, or if not, the sentence “Human rights laws in the context of health system governance and regulations for access to medicines are still too weak to offer effective protection for patients, and prove difficult to implement where they exist” should be deleted Point 18 on page 12 should be deleted as it raises two issues that are in our opinion irrelevant and distracting from the overall key issues. R&D and local production are non-issues for access to NCD medicines, as the necessary medicines are present globally, but are the poorest are lacking access to these. For Question 3 - the role of countries and WHO should be highlighted Question 4 needs to include something on M&E systems Question 5 needs to include something about the role of the WHO Point 28, page 17 - would be good to include and describe specific example of the ADF Question 8 - unclear - these questions need to be refined Point 33 page 19 and 20 - unclear why the example of mDiabetes etc. is included in a discussion paper addressing access to medicines. We would question its relevance. o - - - - Overall the WHO does not need to reinvent the wheel on this issue. There is vast experience, guidelines, etc. present that help countries with their decisions related to medicine procurement and supply, be it for NCDs or other conditions. The issue is the uptake of these by countries, and the technical support provided by WHO, specifically on the inter-linkage of medicines and NCDs. We believe that an important recommendation should be to have a dedicated person on this issue at WHO Headquarters between the Essential Medicines and Health Products and Management of Non communicable Diseases, Disability, Violence and Injury Prevention Departments? Again, on behalf of the IIF, I would like to thank the WHO for this opportunity, and reaffirm the IIF’s commitment to work on this issue. Yours sincerely, Professor Geoff Gill MA, MSc, MD, PhD, FRCP, DTM&H Chair, International Insulin Foundation. Emeritus Professor of International Medicine, University of Liverpool, United Kingdom.
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