Modern trade negotiations have delivered a plethora of bilateral and regional preferential trade agreements (PTAs), which involve considerable risk to public health, thus placing demands on governments to strengthen administrative regulatory capacities in regard to the negotiation, implementation and on-going management of PTAs. In terms of risk management, the administrative regulatory capacity requisite for appropriate negotiation of PTAs is different to that for the implementation or on-going management of PTAs, but at all stages the capacity needed is expensive, skill-intensive and requires considerable infrastructure, which smaller and poorer states especially struggle to find. It is also a task generally underestimated. If states do not find ways to increase their capacities then PTAs are likely to become much greater drivers of health inequities. Developing countries especially struggle to find this capacity. In this article the authors set out the importance of administrative regulatory capacity and coordination to manage the risks to public health associated with PTAs, and suggest ways countries can improve their capacity.
Health equity in economic and trade policies
In this paper, the author argues that, in order to ensure food security for everyone, all aspects of the food security supply chain, global governance, investment and trade will need to be addressed simultaneously. For improving global governance, full support should be given to the work of the reformed Committee on World Food Security (CFS). This may involve merging the United Nations (UN) High Level Task Force with the Committee. At the same time, the Committee may need to work more independently of the Rome-based agencies and report to the UN Economic and Social Council with more coordination than has existed so far. To ensure a functional global food supply system, World Trade Organisation members should consider alternative mechanisms for adjusting trade rules and expanding the mandate of the Committee on Agriculture according to the changing global requirements, the article notes. Thanks to many positive developments such as having a reformed CFS, the Global Partnership on Food Security, substantial new funding and a much more coordinated approach, the global community is in a much better position to reduce global hunger. Unfortunately trade rules are not keeping up with other developments the author concludes.
Uganda is currently preoccupied with reforms for its commercial laws. The
patent law is one of the laws under reform. A draft bill known as the Industrial Property bill is pending submission to cabinet at the time of writing. This report explains the process of reform of the patent law and traces the genesis of the process, stakeholders involvement, as well as the driving force for the reforms.
This article is based upon data gathered during a study conducted in partnership with the World Intellectual Property Organisation on the patent status of products appearing on the World Health Organisation’s 2013 Model List of Essential Medicines (MLEM). It is a statistical analysis aimed at answering: in which developing countries are patents on essential medicines being filed? Patent data were collected by linking those listed in the United States and Canada’s medicine patent registers to corresponding patents in developing countries using two international patent databases (INPADOC and Derwent) via a commercial-grade patent search platform (Thomson Innovation). The respective supplier companies were then contacted to correct and verify their data. The authors tallied the number of MLEM patents per developing country. A subset of 20 of the 375 (5%) products on the 2013 MLEM fit the inclusion criteria. The number of MLEM patents per country was positively associated with human development index (HDI), gross domestic income (GDI) per capita, total healthcare expenditure per capita, population size, the Rule of Law Index, and average education level of the country. Population was a powerful predictor of the number of patent filings in developing countries along with GDI and healthcare expenditure. Broad surveillance and benchmarking of the global medicine patent landscape is valuable for detecting significant shifts that may occur over time. With improved international medicine patent transparency by companies and data available through third parties, the authors suggest that studies such as this will be increasingly feasible.
The regulation of health technologies is a critical component of every country’s public health system and ensures that high-quality, safe health technologies reach the people who need them most. To harness momentum for regulatory harmonization, the Pan-African Parliament, New Partnership for African Development, and African Union Commission spearheaded the development of the African Union Model Law on Medical Products Regulation, which guides member states and regional economic communities in harmonizing regulatory systems and providing an enabling environment for the development and scale-up of health technologies. This paper outlines the measures for implementation of the law.
In a move welcomed by many in the international community, India has granted its first compulsory licence to a local generic drug maker to manufacture and sell a cancer drug, Sorafenib tosylate, which is patented by German pharmaceutical giant, Bayer, under the brand name Nexavar. Compulsory licensing is one of the flexibilities on patent protection under the World Trade Organisation’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement, and it allows developing countries to manufacture affordable generic versions of patented medicines needed for public health in developing countries. Natco, the Indian generic producer, has already developed a process to manufacture the drug, expected to be ready for marketing in April 2011. It is anticipated that Bayer will make an appeal against the decision, which requires Natco to pay a quarterly royalty at 6% of the net sales of the drug, far below Bayer’s asking royalty of 15%. Médecins Sans Frontières said the ruling has ended Bayer’s monopoly in India on the drug and could set a precedent for making more expensive patented drugs available for compulsory licensing.
Authorities in India, the leading producer of generics in the world, have rejected applications for patents on two AIDS drugs, opening the way for cheaper generic versions to be developed and marketed. In the Gleevec case, the Swiss drug company filed a special petition, seeking leave to appeal to the Supreme Court. The petition was to be heard on 31 August but the matter was adjourned after the presiding judge recused himself. India’s patent office has rejected the patents for tenofovir and darunavir, which are expensive but needed for AIDS patients failing on their existing treatments. Brand-name producer Gilead also previously failed to win a patent for tenofovir in Brazil, according to Medicin Sans Frontieres (MSF). The rejection of the patents has yet to be confirmed by official sources. MSF credited Indian Law Section 3(d) with preventing the evergreening of drug patents and opening the way for generics competitors to enter the market.
The Indian Patent Office has rejected patent applications related to two AIDS medicines – lopinavir/ritonavir and atazanavir - on the basis that they did not merit patents under India’s patents law. The decisions mark a major victory for public health, and keep the door open for the production of more affordable generics for patients across the developing world. The patent for atazanavir bisulphate was rejected because it ‘lacked inventive ingenuity’ and the patent for lopinavir/ritonavir was rejected because it did not involve an ‘inventive step’. However the companies have filed other patent applications in relation to these two drugs which are still pending. These decisions show how India’s patent law, which prevents routine improvements from being patented, works in favour of public health by only granting patents for drugs that are truly innovative, according to Médecins Sans Frontières. The article highlights the need to safeguard India’s role as ‘pharmacy of the developing world.’ But as a part of ongoing free trade agreement negotiations, the European Union is pushing for India to accept ‘data exclusivity’ provisions that would effectively block the production of more affordable generics – even when a drug does not merit a patent under Indian law.
India and Brazil have taken the first step towards raising a dispute at the World Trade Organization (WTO) against the European Union (EU) and the Netherlands over the seizure by EU customs of generic medicines in transit to developing countries. Their request for consultations under the WTO Dispute Settlement Mechanism is the first step in the possible establishment of a panel at the Dispute Settlement Body (DSB), if the consultations fail. Indian ambassador, Ujal Singh Bhatia, said that both India and Brazil were concerned primarily over two considerations. Firstly, the seizures seemed to emanate from complaints made by patent holders in Europe, even though the generic drugs were perfectly legitimate under WTO rules in the source countries, as well as in the destination countries. He noted that the intellectual property issues raised were unmerited and international transit guarantees were being violated. Secondly, he noted that the seizures confused intellectual property rights with substandard or spurious medicines. He believed there was a concerted effort to put together a TRIPS-plus enforcement agenda that does away with the flexibilities that are guaranteed to developing countries under the TRIPS regime.
In this report, the authors allege relief for Indian generic drug manufacturers, as five East African countries – Uganda, Tanzania, Rwanda, Burundi and Sudan – refused in a health meeting to endorse a proposal by the East African Community (EAC) to introduce an anti-counterfeit products law. The law, which could have potentially blocked exports of generic drugs from India because of a lack of clarity on what is counterfeit, had worried the Indian drug industry ever since the 2007 draft proposal by the EAC. East African countries together contribute almost one-fifth of India's Rs40,000 core drug exports. Kenya passed a similar law in 2008 that Uganda had used as a model for its own draft Bill last year, and which was due for implementation this year. The Ugandan Bill has been sent back for review. The members of the East African states present at this regional health meeting refused to endorse the draft proposal and demanded that the definition of generics be what WHO [the World Health Organization] stipulates. The views of trade ministers are, however, not made clear in the report.