Source: Business Line
10 March 2014
Trade tensions between the US and India are on the rise. Multiple trade organisations have asked the US Trade Representative to designate India a Priority Foreign Country in its annual review of countries that “deny adequate and effective protection of intellectual property rights.” This would trigger an investigation under the Trade Act that could ultimately lead to sanctions.
Additionally, the US International Trade Commission has been instructed by Congressional leaders to investigate “Indian industrial policies that discriminate against US imports and investment for the sake of supporting Indian domestic industries”.
Much of the controversy surrounds flexibilities in Indian patent law designed to promote access to generic medicines.
The medicines at issue tend to be expensive cancer treatments priced far out of reach for most of the Indians.
The policy pill
Health advocates argue that the policies — including a strict standard for patentable subject matter and the availability of compulsory patent licenses — are precisely the types of policies protected by flexibilities in the WTO’s Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS).
These flexibilities are emphasised by the Doha Declaration, signed by all WTO members in 2001, which reaffirms all countries’ right to structure their intellectual property rights laws in a way that promotes “access to medicines for all.”
Source: MSM GF
10 March 2014
The Global Network of People Living with HIV (GNP+), the International Network of People who Use Drugs (INPUD), the Global Forum on MSM and HIV (MSMGF) and the International Treatment Preparedness Coalition (ITPC) are gravely concerned that exorbitant prices for life-saving hepatitis C treatment will continue to result in unnecessary deaths, including among key populations and people living with HIV. Despite relatively low manufacture costs, a new generation of effective treatment for HCV remains unavailable to people in low- and middle-income countries due to the greed of pharmaceutical companies refusing to lower prices.
The hepatitis C virus (HCV) is a curable infection, yet it kills over 350,000 people each year. Globally, HCV affects an estimated 150–185 million people. It is believed that between 5-20% of people living with HIV worldwide are co-infected with HCV or the hepatitis B virus. This co-infection results in the more rapid progression of liver disease and mortality.
Dr. Eliot Albers, Executive Director of INPUD, said: “HCV is particularly prevalent in communities of people who inject drugs. These communities often face barriers in gaining access to sterile injecting equipment, which can prevent contraction of HCV and are frequently denied treatment even in countries where it is available. Often labeled a ‘silent killer’ or ‘viral timebomb’, the impacts and complications of the virus can go unchecked and unnoticed for 20-30 years. More and more people who inject drugs living with HCV (many of whom are coinfected with HIV) are unable to access treatment.”
Thirty-eight activists from 22 countries convened in Bangkok, Thailand, in February 2014 for the first ever HCV World Community Advisory Board (CAB) meeting to demand equitable access to HCV treatment from six multi-national pharmaceutical companies.
Source: La Repubblica
10 March 2014
Big Pharma has cost Italian health authorities hundreds of millions of euros. More importantly, it may have cost hundreds of thousands of Italians their sight.
On Wednesday Italy’s antitrust authority fined Swiss pharmaceutical giants Novartis AG and Roche Holding AG EURO 92 million and EURO 90.5 million respectively for colluding to prevent the use of a cancer drug as a treatment for a common eye disease. Untreated, wet age-related macular degeneration leads to rapid, irreversible loss of vision. It affects one in three of the over 60s and yet the Italian Society of Ophthalmology estimates that in Italy alone around 100,000 patients have not been given access to the Novartis produced drug Lucentis because of its high cost.
The two companies are accused of excluding Roche’s Avastin from the market and instead channeling demand towards Lucentis. The drugs are identical, but Avastin costs between EURO 15 and EURO 80 per dose and Lucentis costs EURO 900. The two companies agreed to carve up the market between them. Since 2011 they created an artificial distinction between the two products, registering Avastin only for the treatment of cancer and discouraging patients from using it by presenting it as “more dangerous” than Lucentis. The two multinationals also did everything they could to discredit independent research that showed that the two drugs were identical, according to the Italian authority.
Roche, which controls Genentech, the company that first developed Avastin, collected massive royalties from Novartis for the commercialization of Lucentis, a deal that is estimated to have cost Italy’s health system more than EURO 45 million in 2012 alone, with possible future costs of more than EURO 600 million a year, according to the regulator. It is estimated that replacing Avastin with Lucentis will cost the Italian health service EURO 678.6 million in 2014, as opposed to EURO 63.5 if Avastin is adopted. Clearly it is a problem that does not affect only Italy. France has exclusively adopted Lucentis, at a cost to its health service of EURO 700 million.
Source: South Centre
5 March 2014
Unilateral US actions targeting India’s Intellectual Property Laws undermines the Legitimacy of the WTO
Geneva, 4 March 2014
South Centre Calls on WTO Members to Respect the Legitimacy of the Use of TRIPS Flexibilities for Public Health in light of New Threats of Unilateral Trade Measures by the United States against India over its Intellectual Property Laws and Regulations
The South Centre is deeply concerned that developing countries, and more recently the government of India, are facing increasing pressure from the United States of America to reform their intellectual property (IP) laws. The Indian IP laws include balanced provisions to ensure that IP rights do not hinder the ability of the government to adopt measures for promoting development priorities, particularly in the area of public health. These are fully in line with the TRIPS Agreement and reaffirmed by the Doha Declaration on TRIPS and Public Health.
The United States International Trade Commission (USITC) has initiated investigations against India on trade, investment and industrial policies in India particularly on intellectual property protection and enforcement. Moreover, the United States Trade Representative (USTR) is being asked to include India as a priority foreign country in the Special 301 review for 2014, at the request of US industry associations including Pharmaceutical Research and Manufacturers of America (PhRMA), the Biotechnology Industry Organization (BIO), the National Manufacturers Association (NAM), the National Foreign Trade Council (NFTC), the US Chamber of Commerce’s Global Intellectual Property Centre, and the Alliance for Fair Trade with India (AFTI), alleging lack of adequate and effective protection of intellectual property rights (IPRs).
04 March 2014
Abstract Africa has the highest disease burden in the world and continues to depend on pharmaceutical imports to meet public health needs. As Asian manufacturers of generic medicines begin to operate under a more protectionist intellectual property regime, their ability to manufacture medicines at prices that are affordable to poorer countries is becoming more circumscribed. The Doha Declaration on the TRIPS Agreement and Public Health gives member states of the World Trade Organization (WTO) the right to adopt legislation permitting the use of patented material without authorization by the patent holder, a provision known as “compulsory licensing”. For African countries to take full advantage of compulsory licensing they must develop substantial local manufacturing capacity. Because building manufacturing capacity in each African country is daunting and almost illusory, an African free trade area should be developed to serve as a platform not only for the free movement of goods made pursuant to compulsory licences, but also for an economic or financial collaboration towards the development of strong pharmaceutical manufacturing capacity in the continent. Most countries in Africa are in the United Nations list of least developed countries, and this allows them, under WTO law, to refuse to grant patents for pharmaceuticals until 2021. Thus, there is a compelling need for African countries to collaborate to build strong pharmaceutical manufacturing capacity in the continent now, while the current flexibilities in international intellectual property law offer considerable benefits.
Please read the paper here.
Source: The Economist
04 March 2014
The burden of cancer is falling increasingly heavily on the poor
SARA STULAC is a paediatrician, but doctors in Rwanda must be adaptable. One of her first patients after arriving from America in 2005 was a young girl with a tumour the size of a cauliflower on her face. The girl’s father, a subsistence farmer, had tried traditional healers and local doctors, but the tumour had grown, along with his expenses. An oncologist was needed. If only the country had one. Eventually Dr Stulac called one in America who talked her through the treatment that would save the girl’s life.
What makes this story unusual is its happy ending. According to the International Agency for Research on Cancer (IARC), part of the World Health Organisation (WHO), low- and middle-income countries accounted for 57% of the 14m people diagnosed with cancer worldwide in 2012—but 65% of the deaths. Cancer kills more people in poor countries than AIDS, malaria and tuberculosis combined.
Residents of poor countries have long suffered from cancers, such as those of the liver and cervix, that are associated with infections. But as they have grown richer, drinking, smoking and fatty foods have led to more breast, colorectal and lung cancer. Women who used to die in childbirth now live long enough to develop breast cancer. HIV patients on antiretroviral drugs are dying of other causes.
Glass-half-full types view this as a success. But resources have not shifted with the burden of disease. Many developing countries have no trained oncologists, let alone a treatment centre. Even where care is available, the sick often delay because they are poor or do not know that treatment is urgent. Some languages have no word for cancer.
NEW DELHI: Amid heightened scrutiny of the intellectual property regime, the government has decided to tread with caution on a compulsory licence for a cancer drug to ensure that its decision is in line with the legal provisions.
While compulsory licencing, which entails waiver of patent under extreme situations, for three cancer drugs was being pushed by the health ministry, the issue is now limited to Dasatinib, a medicine to treat a type of cancer of the white blood cells, for which Bristol-Myers Squibb (BMS) holds a patent.
Sources said that the commerce and industry ministry recently wrote to the health ministry, rejecting the plea that the government should issue a compulsory licence under section 92 of the Patents Act. Using this provision, the government can only waive the BMS’s patent rights in case of a national emergency or a circumstance of extreme urgency, which was not the case at the moment.There is a third possibility as well, which is to suspend the rights for public non-commercial use in special circumstances, including public health crisis. In fact, the Patents Act has listed AIDS, HIV, tuberculosis, malaria and other epidemics as examples.
Sources said that in case of Dasatinib, this provision may be used but then the health ministry has to clearly show that it has the budget to procure the medicine and supply it under a plan for cancer patients. “You can’t expect a manufacturer to sell the medicine below cost,” said a source.