Combatting counterfeit drugs: Case studies of Cambodia, Vietnam and Thailand

Medicines can save lives only if they are safe, efficacious, of good quality and affordable. The use of unsafe, substandard, ineffective and counterfeit drugs can be harmful to the health of the users and the public. Governments have an obligation to ensure the safety, efficacy and quality of the drugs available to the public by regulating the manufacturing and distribution of drugs and by exercising legal power to control the proliferation of unsafe counterfeit medicines. This article surveys the factual and legal issues surrounding counterfeit drugs in three countries, namely Cambodia, Vietnam and Thailand, in order to determine the magnitude and characteristics of the drug counterfeiting problem within the Southeast Asian region

(En)countering counterfeits in Bangkok: the urban spatial interlegalities of intellectual property law, enforcement and tolerance

In a Bangkok mall a fibreglass policeman warning against intellectual property (IP) piracy stands just metres away from vendors selling fake DVDs; a scene indicative of incomplete and unsuccessful attempts by foreign governments (the US and EU in particular) and corporate actors at enrolment towards ever-higher IP standards – the ‘IP ratchet’ that Drahos (2004 Intellectual property and pharmaceutical markets: a nodal governance approach Temple Law Review 77 401–24) describes. But the scene also reflects cultural resistance at the local level. Both readings exemplify the range of historical, cultural, and politico-legal factors at play that can only be understood through engagement with vendors and consumers in the markets and malls of Bangkok. IP laws may achieve partial ‘closure’ but are regularly changing, contested, variably enforced, and subject to existing social norms such as the ‘cult of imitation’, cultures of legal informality, and a lack of social contract. We found that this lack of legal closure was most pronounced in the day-to-day operation of the Pratunam Market. Whilst other sites host regular crack-downs by police, the IP-specific DSI force, and the Thai courts, markets like Pratunam are mostly immune despite being a transnational trade node for the production and export of counterfeit garments with other developing countries, and a non-conforming node in the IP enforcement context. In the face of persistent efforts to transpose Euro-American IP laws in countries like Thailand, alternative and resistant nodes representing ‘spaces of interlegalities’ are likely to persevere because of the historical context, and the socio-cultural norms of these places

Prices and availability of locally produced and imported medicines in Ethiopia and Tanzania

Background: To assess the effect of policies supporting local medicine production to improve access to medicines. Methods: We adapted the WHO/HAI instruments measuring medicines availability and prices to differentiate local from imported products, then pilot tested in Ethiopia and Tanzania. In each outlet, prices were recorded for all products in stock for medicines on a country-specific list. Government procurement prices were also collected. Prices were compared to an international reference and expressed as median price ratios (MPR). Results: The Ethiopian government paid more for local products (median MPR = 1.20) than for imports (median MPR = 0.84). Eight of nine medicines procured as both local and imported products were cheaper when imported. Availability was better for local products compared to imports, in the public (48% vs. 19%, respectively) and private (54% vs. 35%, respectively) sectors. Patient prices were lower for imports in the public sector (median MPR = 1.18[imported] vs. 1.44[local]) and higher in the private sector (median MPR = 5.42[imported] vs. 1.85[local]). In the public sector, patients paid 17% and 53% more than the government procurement price for local and imported products, respectively. The Tanzanian government paid less for local products (median MPR = 0.69) than imports (median MPR = 1.34). In the public sector, availability of local and imported products was 21% and 32% respectively, with patients paying slightly more for local products (median MPR = 1.35[imported] vs. 1.44[local]). In the private sector, local products were less available (21%) than imports (70%) but prices were similar (median MPR = 2.29[imported] vs. 2.27[local]). In the public sector, patients paid 135% and 65% more than the government procurement price for local and imported products, respectively. Conclusions: Our results show how local production can affect availability and prices, and how it can be influenced by preferential purchasing and mark-ups in the public sector. Governments need to evaluate the impact of local production policies, and adjust policies to protect patients from paying more for local products.Scopu

TRIPS-Plus intellectual property rules: impact on Thailand\u27s public health

Thailandhas proved that a well-fund, politically-supported public policy could be effective in preventing the spread of HIV/AIDS on a national scale. It is currently facing increased pressure to accept higher standards of intellectual property (IP) protection (the so-called TRIPS-Plus) under bilateral free trade agreements (FTA) proposed by theUnited States. The proposed US FTA threatens to restrict the measures the country can take to pursue affordable drugs, and will affect ability ofThailandto continue its successful ARV treatment and other healthcare programmes. The paper argues that the TRIPS-Plus regime generates a negative impact on poor people’s access to medicines, and the ARV treatment programme inThailandis presented as an illustrative example

Legal protection of traditional knowledge A Thai perspective

The protection and promotion of traditional knowledge (TK) may rely on a set of legal instruments or non-legal mechanisms. Legal issues that may arise include ownership, objectives of protection, accessibility, protection under IP law, TK databases, and contractual arrangements. This article begins by exploring how the current legal system can protect customary knowledge and how an effective legal ré-gime for this purpose may be instituted and operated. It ends by discussing Thailand's attempts to protect its TK. In the process it highlights salient points under the two sui generis laws that have been adopted in the country

Patent rights in pharmaceuticals in developing countries: major challenges for the future

India\u27s 2005 adoption of a TRIPS-consistent patent regime will reveal whether Indian generic pharmaceuticals companies will continue to supply essential drugs for developing nations such as Thailand, who are reliant on India for the supply of cheap medicines. Patent Rights in Pharmaceuticals in Developing Countries investigates the public policy and public health implications of pharmaceutical patenting in countries such as India and Thailand.The book engages with a broad range of new case studies, providing a detailed examination of options for the resolution of access-to-medicine issues at global, national and local levels. In addition, the book reflects the significant progress in international and national patent law and in international policymaking in this area.Broadly accessible, the work will appeal to advanced undergraduate and postgraduate students, as well as researchers and academics in fields such as intellectual property law, public health, industrial economics, development studies and political science. National policymakers and government officials, as well as professionals based in international organizations and pharmaceutical industries, will also find this exciting work of great interest

Appropriate patent rules in developing countries - Some deliberations based on Thai legislation

TRIPS Agreement mandates adequate and effective protection for all inventions regardless of the field of technology. The fundamental questions are whether the extent of protection of pharmaceuticals will be beneficial for the socio-economic development of developing countries and how can the impact of the new system be monitored and controlled in the interests of the concerned countries and their populations. Under the Thai Patent Law, Section 46.50 provides for the grant of compulsory licenses, which in practical terms are difficult to implement so much so that no such licenses have been granted since 1979 when the Act came into force. Lack of know-how to work the patent in Thailand has also been a serious deterrent. Provision of a requirement for working of patented inventions is also part of the Thai Act. Section 36(2) of the Thai Patent Law authorizes parallel imports into Thailand if the products are marketed abroad by the patentee or his licensee. Section 9 (4) of the Act adopts the principle that methods of treatment are not patentable. Section 31 permits opposition to be filed after the application is published by the Patent Office. The implication of TRIPS and the Thai Patent Act on the pharmaceutical sector and on the patients in Thailand are discussed in this paper

Intellectual Property Harmonisation under the Trans-Pacific Partnership Agreement: Issues and Challenges

The Trans-Pacific Partnership Agreement (TPP) was negotiated by 12 Pacific-rim countries, namely: Australia, Brunei, Canada, Chile, Japan, Malaysia, Mexico, New Zealand, Peru, Singapore, the United States, and Vietnam. Intellectual property (IP) is one of the most important issues in the TPP negotiations. The Agreement will introduce higher standards of IP protection than required in the World Trade Organization (WTO) Trade-Related Aspects of Intellectual Property Rights (TRIPS) TRIPS (so called TRIPS-Plus provisions). The IP chapter under the TPP would undermine countries\u27 substantive ability to deal with public health problems. First, the proposed rules would have negative implications for access to medicines by limiting flexibilities that the countries currently have under the WTO/TRIPS Agreement, e.g. restricting the right of governments to allow the production, marketing, and import of generic medicines. In addition, the treaty has introduced language that will undermine the ability of the participating countries to make use of compulsory licensing as a means to obtain differentially priced generic products and to restrict the measures it can take to pursue affordable drugs. In making decisions with respect to whether or not a country should join the TPP, its policymakers will have to weigh, based on empirical evidence, the economic benefits of such a treaty against the importance of protecting health and social interests of their population

Current developments and trends in the field of intellectual property rights : harmonisation through free trade agreements

Meeting: Intellectual Property Rights (IPRs), Innovation and Sustainable Development, 8-10 Nov. 2004, Hong Kong, CNIn IDL-5102

Appropriate Patent Rules in Developing Countries - Some Deliberations Based on Thai Legislation

447-455TRIPS Agreement mandates adequate and effective protection for all inventions regardless of the field of technology. The fundamental questions are whether the extent of protection of pharmaceuticals will be beneficial for the socio-economic development of developing countries and how can the impact of the new system be monitored and controlled in the interests of the concerned countries and their populations. Under the Thai Patent Law, Section 46.50 provides for the grant of compulsory licenses, which in practical terms are difficult to implement so much so that no such licenses have been granted since 1979 when the Act came into force. Lack of know-how to work the patent in Thailand has also been a serious deterrent. Provision of a requirement for working of patented inventions is also part of the Thai Act. Section 36(2) of the Thai Patent Law authorizes parallel imports into Thailand if the products are marketed abroad by the patentee or his licensee. Section 9 (4) of the Act adopts the principle that methods of treatment are not patentable. Section 31 permits opposition to be filed after the application is published by the Patent Office. The implication of TRIPS and the Thai Patent Act on the pharmaceutical sector and on the patients in Thailand are discussed in this paper