Drug Information Bulletin

Drug Information Centre (DIC) Indian Pharmaceutical Association

Bengal Branch Tele fax: 033 24612776, E-mail: ipabengal.dic@gmail.com Web Site: http://www.ipabengal.org Contact: 09830136291

Volume: 06

Number: 41

19th January 2013

Content MDR-TB a major problem for BRICS nations Press Information Bureau (PIB), Government of India Compulsory licence likely for three cancer drugs in India USFDA approves first skin patch for Migraines

MDR-TB a major problem for BRICS nations Press Information Bureau (PIB), Government of India DELHI COMMUNIQUE 1. The BRICS countries, represented by the Ministers of Health of the Federative Republic of Brazil, the Russian Federation, India, People's Republic of China and Republic of South Africa, met in New Delhi on 11 January 2013 at the Second BRICS Health Ministers' Meeting. 2. The meeting recalled the Delhi Declaration of 29 March 2012 during the BRICS leaders summit and the Joint Communiqu of the BRICS Health Ministers at Geneva of 22 May 2012 including specific areas of work under the BRICS Health Platform for each Member State, focussed on the theme "BRICS Partnership for Global Stability, Security and Prosperity" to address emerging health threats. 3. The Ministers recalled that BRICS is a platform for dialogue and cooperation amongst countries representing 43% of the world's population. The Ministers reiterated their commitment to the Beijing

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Declaration of July 2011 for strengthened collaboration in the area of access to public health and services in BRICS States including implementation of affordable, equitable and sustainable solutions for common health challenges. The Ministers committed to strengthen intra-BRICS cooperation for promoting health of the BRICS population. The BRICS Health Ministers resolved to continue cooperation in the sphere of health through the Technical Working Group. 4. The Ministers drew attention to the current global threat of non-communicable diseases and noted that in 2008, around 80% of all NCD deaths occurred in low and middle income countries. The Ministers recognized the significant role of BRICS countries in the global process of prevention and control of NCDs including the Moscow Declaration of April 2011, the WHA Resolution 64.11 of May 2011 and the Political Declaration of the UN General Assembly of September 2011.The Ministers recognized the need for more research into the social and economic determinants leading to occurrence of non-communicable diseases, amongst the BRICS countries. They resolved to collaborate and cooperate to promote

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access to comprehensive and costeffective prevention, treatment and care for the integrated management of noncommunicable diseases, including access to medicines and diagnostics and other technologies. 5. The Ministers also recognized the need to combat mental disorders through a multi-pronged approach including the World Health Assembly Resolution 65.4, consideration of a Comprehensive Mental Health Action Plan through sharing of innovations in the field of Mental Health Promotion, diagnosis and management, exchange of best practices and experiences amongst BRICS countries. 6. The Ministers renewed their commitment to the WHO Framework Convention on Tobacco Control and stressed the importance of research and study by WHO and other stakeholders into the social and economic determinants of tobacco use and its control. 7. The Ministers recognized that multidrug resistant tuberculosis is a major public health problem for the BRICS countries due to its high prevalence and incidence mostly on the marginalized and vulnerable sections of society. They resolved to collaborate and cooperate for development of capacity and infrastructure to reduce the prevalence and incidence of tuberculosis through innovation for new drugs/vaccines, diagnostics and promotion of consortia of tuberculosis researchers to collaborate on clinical trials of drugs and vaccines, strengthening access to affordable medicines and delivery of quality care. The Ministers also recognized the need to cooperate for adopting and improving systems for notification of tuberculosis patients, availability of anti-tuberculosis drugs at facilities by improving supplier performance, procurement systems and logistics and management of HIVassociated tuberculosis in the primary health care system.

8. The Ministers called for renewed efforts to face the continued challenge posed by HIV. They committed to focus on cooperation in combating HIV/AIDS through approaches such as innovative ways to reach out with prevention services, efficacious drugs and diagnostics, exchange of information on newer treatment regimens, determination of recent infections and HIV-TB coinfections. The Ministers agreed to share experience and expertise in the areas of surveillance, existing and new strategies to prevent the spread of HIV, and in rapid scale up of affordable treatment. They reiterated their commitment to ensure that bilateral and regional trade agreements do not undermine TRIPS flexibilities so as to assure availability of affordable generic ARV drugs to developing countries. 9. The Ministers committed to strengthen cooperation to combat malaria through enhanced diagnostics, research and development and committed to facilitate common access to the technologies developed or under development in the BRICS countries. 10. The Ministers renewed their commitment for effective control of both communicable and non-communicable diseases through cooperation in sharing of existing resource information, development of risk assessment tools, risk mitigation methods, referral systems, life course approaches, community empowerment, monitoring health impact assessments of all public policies at national and international levels. 11. Recognizing that an effective health surveillance, including injury surveillance, is the key strategy for controlling both communicable and non-communicable diseases, that surveillance is also the cornerstone around which the implementation of the International Health Regulations (2005) is based and further recognizing that the countries may be

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using different models for surveillance based on different realities and best practices, the Ministers committed to strengthen cooperation in the mechanisms for planning, monitoring and evaluating disease prevention and control activities and capacity-building for effective health surveillance systems. 12. The Ministers urged focus on the unique strength of BRICS countries such as capacity for R & D and manufacturing of affordable health products, and capability to conduct clinical trials. The Ministers called for strengthened cooperation in application of biotechnology for health benefits for the population of BRICS countries. 13. The Ministers emphasized the importance of child survival through progressive reduction in the maternal mortality, infant mortality, neo-natal mortality and under-5 mortality, with the aim of achieving the Millennium Development Goals. They confirmed their commitment to a renewed effort in this area and to enhance collaboration through exchange of best practices. 14. The Ministers discussed the recommendations of the Consultative Expert Working Group on Health on coordination and financing of R & D for medical products and welcomed the proposal to establish a Global Health R&D observatory as well as the move on holding regional consultations to set up R&D demonstration projects. The Ministers urged that the entire process, including priority setting, should be driven by WHO Member States and should be based on public health needs, in particular those of developing countries, with the cost of R & D delinked from the final products. 15. The Ministers reiterated their support to the continued discussions on the process of reform of WHO, to better respond to global challenges in programmatic, organizational and

operational terms, including the future financing of WHO, and welcomed the proposal to establish a financing dialogue based on priorities collectively set by WHO Member States in a structured and transparent process. 16. The Ministers acknowledged the value and importance of traditional medicine and need of experience and knowledgesharing for securing public health needs. They urged for cooperation amongst the BRICS countries through visits of experts, organization of symposia to encourage the use of traditional medicine, in all spheres of health. 17. The Ministers confirmed their support for the United Nations General Assembly Resolution on universal health coverage and committed to work nationally, regionally and globally to ensure that universal health coverage is achieved. 18. The Ministers recalled the Beijing Declaration of the 1st BRICS Health Ministers' Meeting in 2011, emphasizing the importance and need of technology transfer as a means to empower developing countries. In this context, they underlined the important role of generic medicines in the realization of the right to health. The Ministers renewed their commitment to strengthening international cooperation in health, in particular South-South cooperation, with a view to supporting efforts in developing countries to promote health for all and resolve to establish the BRICS network of technological cooperation. 19. The Ministers acknowledged the need of use of ICT in Health services to promote cost-effective treatment in the remote areas. They encouraged to strengthen cooperation amongst the BRICS countries to share their experiences in e-Health including tele-medicine. 20. The Ministers agreed to cooperate in all international fora regarding matters relating to TRIPS flexibilities with a public health perspective.

21. The Ministers agreed to establish platforms for collaboration within BRICS framework and with other countries with a view to realizing the goals and objectives outlined in this Declaration. Press Information Bureau Government of India New Delhi January 11, 2013 http://pib.nic.in/newsite/erelease.aspx?reli d=91533 Compulsory licence likely for three cancer drugs in India The government has appointed a panel to look into issues related to compulsory licensing of drugs and whether cheaper versions of cancer medicines Trastuzumab, Ixabepilone and Dasatinib can be launched under the provision, a person with knowledge of the development said. According to the person, the health ministry has sent its proposal regarding compulsory licensing for the three drugs to the Department of Industrial Policy and Promotion (DIPP), which in turn has sought the opinion of the department of pharmaceuticals. Srikant Jena, Minister of State for Chemicals and Fertilisers, however, denied having received any note. The panel is lead by RK Jain, additional secretary and financial advisor in the health ministry, the person added. Compulsory licensing is a provision under the World Trade Organisation that allows a government to permit a company to manufacture a patented drug without the consent of the innovator company. Each of the three drugs cost over Rs 1 lakh for a month's dose. While Trastuzumab is manufactured by Roche, Ixabepilone and Dasatinib are products of Bristol-Myers Squibb.

In March last year, India had allowed Hyderabad-based Natco Pharma to make and sell a cheaper version of Bayer AG's patented cancer drug Nexavar on grounds of affordability. The move had multinational pharma companies worried about property protection. According to intellectual property lawyer Aliasgar Dholkawala, the health ministry could apply for a compulsory licence (CL) under Sec 92 of the Indian Patent Act. "The government can notify a patent for issuance of CL under Sec 92 if any of these three conditions are met: national emergency, cases of extreme urgency, or in case of public non-commercial use," Dholkawala of Wadia Ghandy and Co said. Under Sec 92, the government can issue a compulsory licence on certain patents notified in the gazette. After the same is notified by the government, any company interested in its manufacture is allowed approach the patent controller for a licence. Experts say the move could spark a fresh row in the area of intellectual property. Besides, the government is expected to release a draft report on price control for patented medicines, which may not leave much room for a compulsory licence, they add.
Source: ET Bureau Jan 14, 2013

USFDA approves first skin patch for Migraines. Bloomberg News reports that the Food and Drug Administration has approved its migraine treatment, Zecuity, a skin patch that "delivers sumatriptan, the mostprescribed migraine headache medication, through a mild electrical current." The Conshohocken, Pennsylvania-based drug developer said it expects to begin selling Zecuity, which will be the first skin patch for the neurological disorder on the market, "in the fourth quarter of this year."

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