According to this article, February 2012 is a key month for the future of the life-saving Indian generic industry, because fights on all three fronts (EU-India FTA, TPPA, and Novartis v. India) are occurring simultaneously - all with the same objective of using intellectual property rules that will significantly reduce the ability of Indian suppliers to produce and export low cost generic medicines. The European Union (EU) has put great pressure on India to conclude a trade agreement that includes TRIPS-plus IP protections, particularly in terms of investor-versus-state claims, general IP enforcement measures, and data exclusivity. In sum, the EU wants to enshrine IP-right holders and other investors rights to bring private arbitration claims directly against India when their investment-return expectations are upset by government regulations or other actions. February is also a key month in the ongoing TPPA negotiations, with side meeting on IPRs scheduled in Hollywood as a precursor to major negotiation in early May in Melbourne. The United States (US) attack on India-style protections against patent monopoly evergreening is quite explicit in its leaked TPPA demands. Contrary to the direct rule of Sec. 3(d) of the India Amended Patents Act (2005), the US is trying to mandate that patent be granted on minor changes in the form, new uses, and dosages, formulations, and combinations of known chemical entities. It also seeks mandatory patent term extensions, disallows the kind of pre-grant oppositions used so effectively by activists in India, and insists on data exclusivity and patent-registration linkage. Moreover, the US seeks to limit price control mechanisms like those currently used in India and seeks enforcement rights even more onerous than those pursued by the EU.
Public-Private Mix
In 2006 the drug company Novartis took the Indian government to court over its patent law, in a move that threatened access to affordable medicines produced in India for millions of people across the developing world. The company wanted to get the law changed so that they could more easily extend the patents on their products, and stop generic companies producing the same medicines at a fraction of the price. MSF’s Drop the Case campaign, launched in response to this move, gathered nearly half a million signatures calling on the company to drop its case. But six years later, the legal battle continues. India’s Supreme Court is now due to give the final judgement on the case this year. In August 2007, the Madras High Court in August 2007 ruled against Novartis. Undeterred, the company has continued to appeal against each legal reversal, with the result that India’s final court – the Supreme Court - is now due to hear the case. To add your voice to the discussion, visit: http://www.msfaccess.org/STOPnovartis/
South Africa’s Competition Commission is considering initiating a market inquiry into the private healthcare industry reminiscent of its probe into the banking sector a few years ago, which recommended lower banking costs. Health Minister Aaron Motsoaledi has condemned high healthcare costs and accused the private health sector of engaging in "uncontrolled commercialism" and "destructive, unsustainable practices". Tembinkosi Bonakele, deputy commissioner of the Competition Commission, said that the commission was "likely" to commence with an inquiry because of growing concern about the high cost of private healthcare and the effect this had on the public healthcare system.
Medicins Sans Frontiers (MSF) argues in this article that big pharmaceutical companies are charging too much for their vaccines used in the developing world. Price disclosures by GlaxoSmithKline (GSK) and Johnson & Johnson show that these companies have been selling some vaccines at premiums of up to 180%. According to MSF, GSK and Pfizer are selling 30 million doses of pneumococcal vaccines annually to GAVI at a reduced price of US$3.20 through a scheme called Advance Market Commitment, but are also each getting a subsidy of US$215 million. Emerging country suppliers like India’s Serum Institute have said they could sell similar pneumococcal vaccine products for US$2 a dose – a 40% reduction on the GSK and Pfizer price. Serum Institute said recently that if they had not faced patent restrictions, the vaccine could have been available by 2012 – now it is not expected until 2015. Technology transfer and product development grants to low-cost suppliers are being supported by the Bill and Melinda Gates Foundation, but these sums are dwarfed by the Advance Market Commitment subsidy to Big Pharma. MSF calls on GAVI to start thinking about more affordable vaccines and calls on government donors to pressurise GAVI to foster competition and to push for products especially adapted for developing countries.
Alcohol is the third leading contributor to death and disability in South Africa, where SABMiller is the major supplier of malt beer, the most popular beverage consumed. The Global Fund to Fight AIDS, Tuberculosis and Malaria (Global Fund) has recently included SABMiller as a recipient of funding for an education intervention aimed at minimizing alcohol-related harm, including HIV prevention, among men in drinking establishments. Global Fund support for this initiative is cause for concern, according to the authors of this article. They argue that it is debatable whether these men are the best target group for the intervention, whether a drinking establishment is the best location, and whether the educational intervention itself is effective. The authors argue that the industry supports interventions that will not affect drinking rates at a population level. These interventions allow the industry to fulfil social and legal obligations to address the harmful use of alcohol while ensuring that sales and profits are maintained. Providing funding for an industry that could afford to fund its own interventions also reduces the funds available for less well-resourced organisations.
Markets for life-saving vaccines do not often generate the most desired outcomes from a public health perspective in terms of product quantity, quality, affordability, programmatic suitability and/or sustainability for use in the lowest income countries, according to this paper. The perceived risks and uncertainties about sustainably funded demand from developing countries often leads to underinvestment in development and manufacturing of appropriate products. The pilot initiative Advance Market Commitment (AMC) for pneumococcal vaccines, launched in 2009, aims to remove some of these market risks by providing a legally binding forward commitment to purchase vaccines according to predetermined terms. To date, 14 countries have already introduced pneumococcal vaccines through the AMC with a further 39 countries expected to introduce before the end of 2013. The authors of this paper describe early lessons learnt on the selection of a target disease and the core design choices for the pilot AMC. They highlight the challenges faced with tailoring the AMC design to the specific supply situation of pneumococcal vaccines and points to the difficulty – and the AMC’s apparent early success – in establishing a long-term, credible commitment in a constantly changing unpredictable environment. One of the inherent challenges of the AMC is its dependence on continuous external funding to ensure long-term purchases of products. The authors examine alternative design choices and aim to provide a starting point to inform discussions and encourage debate about the potential application of the AMC concept to other fields.
This paper examines the experuence of the the new Queen Mamohato Memorial Hospital, a US$120 million privately financed hospital in Lesotho's capital Maseru, the first in Africa to be built through a “Public Private Investment Partnership” (PPIP). According to the World Bank, the new hospital is supposed to operate as the national referral hospital as well as the district hospital for the greater Maseru area. It was built and is run by a consortium headed up by South African private medical giant Netcare, and replaced the Queen Elizabeth II Public Hospital. In return, the Lesotho government will pay a US$32.6m index-linked annual ‘unitary charge’ to Netcare for the hospital and services, representing a 100% increase in costs from the 2007/08 budget and despite the fact that the government had already invested $62 million in the project. The new hospital is expected to treat all patients who present, up to a maximum of 20,000 in-patient admissions and 310,000 outpatient attendances annually, against an estimated need of 64,000 patients annually. The annual charge for the hospital is a third of Lesotho’s recurrent health budget. The author suggests that this can distort national health spending, especially for the expansion of primary health care for Lesotho’s majority rural population. The unfavourable terms of the contract are traced back to an imbalance in expertise among those negotiating the contract terms. The authors questioned why the International Finance Corporation, who acted as consultants on the project, failed to support the Lesotho negotiators to prevent these unfavourable terms.
A Kenyan pharmaceutical company, Universal Corporation, is reported to have been certified by the World Health Organisation (WHO) to start producing antiretroviral (ARV) drugs. The company alleges that the cost of its medicines will be at least 30% cheaper than those the government is currently buying from foreign manufacturers in countries like India, largely as it will avoid high importation costs. The authors note that whether or not the government will buy medicines locally depends on their pricing. Activists have called on WHO to certify more local manufacturers to produce high-quality generic drugs. Government officials have welcomed the development as a step in providing universal coverage to all HIV-positive Kenyans.
The concept of ‘water operator partnerships’ (WOPs) has increasingly been promoted as a means to improving water services provision in developing countries. The International Water Association (IWA)defines WOPs as ‘any formal or informal collaboration or structured partnership aimed at capacity building on a not-for-profit basis. In the WOPs approach emphasis is on capacitating (rather than replacing) the public organisation. Researchers assessed the potential of such partnerships as a ‘model’ for contributing to the Millennium Development Goals (MDGs), by focusing on four water utilities in Mozambique. Although, the study found these partnerships to be successful, their replicability and potential for scale up was found to be quite limited. The study found that WOPs depended for success on the availability of investment funds, and the level of commitment to the partnership, both financial commitment and time and effort of the organisations involved.
The Global Business Coalition for Health (GBCHealth), which took part in the United Nations Conference on Non-Communicable Diseases (NCDs) held in New York in September 2011, has argued that companies must have a place at the tables where their future is discussed. GBCHealth, which represents companies that manufacture unhealthy (junk) foods and tobacco products, believes that their expertise is essential to developing public health policy. But activists disagree, arguing instead that industries producing unhealthy products should not be viewed as trusted partners and should not have a seat at the table during public health negotiations. In this open letter, AIDS activist Gregg Gonsalves responds to GBCHealth’s article justifying their right to be part of the negotiations. Though GBCHealth has had a long history of working on HIV and AIDS, he argues that big business cannot be considered representative of civil society, which is largely composed of marginalised groups, civil society organisations and other interested parties whose fight for civil, social and economic rights are not part of big business, whose primary goals are profit oriented. He calls on big business to stop trying to halt generic production of anti-retrovirals and drugs for NCDs (such as Novartis' continuing attempts to alter Indian patent law), to stop selling and promoting cigarettes and to stop advertising and marketing of high-sugar and high-fat foods across the globe.