Info Service on Health Issues (Nov14/01)
Joint Symposium to focus on innovation and access challenges in MIC
Geneva, 5 November (TWN) – The fourth joint symposium of WHO, WTO and WIPO will focus on innovation and access challenges in the middle-income countries.
The one-day symposium titled “Innovation and Access to Medical Technologies: Challenges and Opportunities for Middle-Income Countries” is taking place today at the WIPO headquarters.
According to the background note the symposium is to “shed light on the concept of rating countries according to their gross national income, in particular, why such a benchmark alone is not adequately reflecting the public health situation and what public policies are needed to ensure that economic growth contributes to achieving Universal Health Coverage”.
Further, the symposium is also to address “the twin challenges of promoting biomedical innovation within middle-income countries while ensuring access to that innovation”.
The symposium has three technical panels:
The first panel will discuss the concept of middle-income countries (MIC): What does it mean? How do we measure capacity for innovation? What are the factors of success? The second is on trends in medical technologies innovation in MIC. The third is on the challenge of ensuring access to medical technologies in MIC.
The symposium also has a 30-minute session on ebola titled “Ebola: Innovation and Access to New Treatments.”
The opening session will be addressed by Xiaozhun Yi, Deputy Director-General of WTO, Marie-Paule Kieny, Assistant Director–General, Health Systems and Innovation, WHO, Johannes Christian Wichard, Deputy Director-General, Global Issues Sector, WIPO.
The background note clearly brings out the fallacy of MIC. The World Bank Classification classifies countries as MIC if their gross national income is within the range of US$ 1,045 -12,615. Currently 105 countries are classified as MIC. This group is further divided into lower middle income countries (LMIC) and upper middle income countries (UMIC). Currently 50 countries are classified as LMIC and 55 countries are UMIC.
According to the background note, “The current 105 middle-income countries include 17 countries that, in the UN system, are considered least developed countries, due to the different selection criteria for the two groups”. It further states: “While the World Bank’s main criterion for classifying economies is gross national income, the United Nations Committee for Development Policy uses two additional criteria, the human asset index and the economic vulnerability index”.
The background note also clearly states: “ Given that the gross national income in many of these countries is unequally distributed, the rating as a middle-income country does not mean that the majority of people in these countries are well off. Today, more than three-quarters of poor people in the world who live on less than US$ 2 per day are in middle-income countries rather than in low-income countries”.
The notes states that in the absence of widespread health insurance coverage and the lack of international aid and assistance, access to health services and especially medicines is a huge problem and put poor people in MIC at risk.
The situation is getting worse due to the recent development of excluding MIC especially those in the UMIC from the voluntary licences (VL) granted by patent holding pharmaceutical giants to selected generic medicines manufacturers. These VLs not only exclude the MIC from the scope of the licences but also cut the supply line by giving VLs to limited selected companies and preventing them from supplying to the excluded MIC. In the absence of manufacturing capability many MIC depend on generic companies from India and the VLs issued to Indian pharmaceutical companies prevent them to supply to excluded MIC. As a result, MIC that do not have the manufacturing capability cannot even use the TRIPS flexibilities like compulsory license to import.
A stark case is the recent Gilead Sciences VL on sobosfovir given to several Indian companies that exclude MIC from the scope of its VL even when there are no valid patents in force in the excluded MIC. The restrictions in the Gilead licence make it difficult to supply to the excluded MIC under a compulsory license.
According to Health Global Access Project (Health Gap), the Gilead licence excludes nearly 49 million people in MIC from accessing sobosfovir, a crucial hepatitis C medicine, at an affordable price. The background note acknowledges this problem and states: “Middle-income countries have often been at the heart of the debate on the impact of intellectual property (IP) on access to medicines in the past years: one of the most controversial aspects of the increasing number of voluntary license agreements in the area of antiretroviral treatment for HIV is the inclusion or exclusion of middle-income countries. With the upcoming new treatments for hepatitis C, there is even greater focus on middle-income countries that bear a very high disease burden. To achieve their public health objectives, middle-income countries appear to be adopting different IP strategies.’
VLs issued to Indian pharmaceutical companies through the Medicines Patent Pool also exclude MIC.
The interesting thing to watch out for at the WHO/WTO/WIPO symposium is whether there will be a clear articulation on the use of TRIPS flexibilities such as the use of compulsory licence/government use order to address the challenges of access to medical technologies including new medicines.+