Today there is a real attempt by certain actors to confuse the debate about substandard, counterfeit and generic drugs. Articles in the media often discuss counterfeit, substandard and generic medicines as if they are all one problem and the same solution can be used for all of them. This confusion can have a negative impact – because if the public believes that generic medicines are the same as counterfeit medicines, they will lose confidence in generic medicine. Another negative consequence of confusing counterfeit and generic drugs, is that this often leads to calls for stronger intellectual property enforcemement, which then creates access to medicines problems. Even at the level of policy makers, these confused messages can have a very negative effect. The World Health Organization (WHO) has a role to play in supporting national regulators to take measures against both counterfeit and substandard medicines. But, perhaps most importantly, WHO should shift its attention to substandard medicines, a much bigger problem.
Health equity in economic and trade policies
Counterfeit medicines were left off this year’s World Health Assembly agenda in May, and some countries suggested that the World Health Organization (WHO) was overstepping its mandate into intellectual property enforcement rather than public health. ‘WHO will not do the work of WIPO [World Intellectual Property Organization] or the WTO [World Trade Organization]’, by becoming involved in IP, WHO’s director general, Margaret Chan, has said. Nevertheless counterfeit medicines were felt by others to be an isssue, and appear in the medium-term strategic plan, which outlines WHO’s expected activities for the years 2008–2013.
Countries negotiating the final declaration text for the first-ever UN High-level Meeting on Tuberculosis in September were put under significant pressure to drop references to protecting countries’ rights to take fully-legal actions to access affordable medicines for their people, Médecins Sans Frontières reports. One of the final sticking points in the negotiations in New York was language on public health safeguards enshrined in the World Trade Organization’s (WTO) Agreement on Trade-related Aspects of Intellectual Property Rights (TRIPS). This allows governments, among other things, to issue ‘compulsory licenses’ to override patents in the interest of public health, so that they can allow generic versions to be produced or imported and more people can receive needed treatment. The ‘Group of 77’ bloc of developing countries has been under pressure to drop all references to the WTO’s 2001 Doha Declaration that enshrined public health flexibilities and safeguards in the TRIPS agreement. This led to a call by Leena Menghaney, South Asia Head for MSF’s Access Campaign for all countries, including those in the Group of 77, and Brazil, Russia, India, China and South Africa, that have a high burden of TB, to urgently stand up right now against what they refer to as 'bullying', that aims to keep medicines out of the hands of people who need treatment.
South Africa’s environment law has a strange loophole. In theory, every activity that would harm the environment falls under the National Environmental Management Act (Nema) and the Acts linked to it. This allows the government to uphold everyone’s constitutionally guaranteed right to a healthy environment. Nema is what should give the environment department teeth. But mining is exempt because of a 2014 takeover by the mineral resources department of most environmental oversight for mining. Now, far-reaching court decisions are pulling apart the way in which the mining department discharges its job of looking after the environment, and questioning how positive a development this has been. In a stinging rebuke last week, the high court ruled in defence of a wetland in Mpumalanga. This has created a precedent that rights groups say they will use to challenge other cases when mines threaten the environment. This decision follows a judgment earlier this month by the Constitutional Court in a case between residents of villages that fall under the Bakgatla Ba Kgafela tribal administration, near Rustenberg in the North West, and a would-be mining company. Read together, the environmental and land rights judgments are argued by the author to be a serious blow to the carte blanche attitude of the minerals department and its mandate to expand mining. Mining companies will now have to consult all residents. The minerals department will also have to do more than tick boxes based on information given by mines when it comes to looking after the environment.
Are counterfeit products first and foremost a threat to human health and safety or is provoking anxiety just a clever way for wealthy nations to create sympathy for increased protection of their intellectual property rights? This article indicates that coverage of this issue in the world’s news media varies greatly. Some argue that attempts to fight fake drugs are as much a risk to access to the real medicines as the fakes themselves. Legitimate, low-cost generics – often the only medicines the poor can afford – can get caught in the crossfire of anticounterfeiting enforcement measures. In addition, they say, there is need to combat not only medicines that violate trademarks (as counterfeit is often defined) but also medicines of general low quality (harder to spot and often, some say, a greater problem). The article examines a variety of news items that have recently appeared in the international media. Sources in American media have focused on organised crime in drug counterfeiting without considering the problems of access to medicines in developing countries. On the other hand, India’s newspapers are concerned with the impact of new legislation on the production of generics and the United Kingdom’s BBC has acknowledged the problems of access to medicine.
At the WTO’s TRIPS Council meeting on 30 July, members discussed South Africa’s proposal (IP/C/W/665) for members to come up with proposals, share information and national experiences, pointing out how the 2030 SDGs may be achieved through an effective framework for technology transfer. India reminded the TRIPS Council that any discussion on “E-Commerce will lack meaning if the gaping digital divide, partly arising out of lack of access to technologies and furthered by the pandemic, continues to exist.” In conclusion, India said that “it is of utmost importance for developing countries to adopt e-commerce and IP policies that are mutually supportive and in line with their developmental goals and policy specificities.”
Many people in developing countries lack access to health technologies. This paper presents seven findings about processes that shape access, based on analysis of six case histories: praziquantel to treat schistosomiasis (a parasitic worm disease), hepatitis B vaccine, the Norplant contraceptive, malaria rapid diagnostic tests, vaccine vial monitors and the female condom. Each case study is assessed with a comprehensive framework that examines the effects of architecture, availability, affordability and adoption on creating access. The analysis shows that access to health technology in poor countries is difficult to achieve because of multiple obstacles, but it can be created under certain conditions.
The Global Call to Action Against Poverty (GCAP) has urged every government attending Doha to reform the global economic system in more democratic forums so the people affected by poverty have a full and equal say. A new financial architecture must deal with global imbalances, the need for government regulation and interventions for each developing country. GCAP was represented at the Financing for Development meeting in Doha by members of the Feminist Taskforce and Arab region, African, Asian and European coalition members and co-chairs. The long-term solution to the financial crisis requires much more than re-establishing rich countries’ economies and bailing out banks. The world needs solutions for a new financial and trade architecture that could provide for the poor and often voiceless people in the world.
The year 2008 is halfway to the deadline for reaching the Millennium Development Goals. Despite some progress, this article argues that they will not be achieved if current trends continue. Starting with the G8 meeting in Japan, rich countries must use a series of high-profile summits in 2008 to make sure the MDGs are met, and tackle both climate change and the current food crisis. Oxfam proposes an agenda into the G8 this year that includes action on specific areas: stop burning food and start supporting poor farmers; mend broken aid promises; support health, education, water and sanitation for all; and put women and girls first. The report points to a similar situation regarding climate change, where it argues that a lot of the money pledged to help poor communities to cope with the effects of changing weather patterns is simply being taken from existing aid budgets or being made into loans.
Rodrigo Rato bowed out as managing director of the International Monetary Fund with effusive plaudits from world financial leaders in public but sharp criticism of his role and the Fund's relevance from the same people when talking outside official news conferences. The emerging consensus among rich and poor countries alike was that the reform process of the IMF had moved backward. Worse, they added that acrimony over the Fund's role in assessing the economic policies of its members, their effects on other countries threatened to create just the disorder in the global economy it is intended to prevent.