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GENERICS CRUCIAL FOR TREATMENT Affordable and quality medicines could mean a difference between life and death. By Shila Kaur United Nations agencies have stressed the pivotal role of generic medicines for access to affordable medicines, particularly in developing countries. The World Health Organisation's Department of Essential Medicines and Health Products (EMP) and UNITAID jointly organised a side meeting on 22 May alongside the recently concluded 66th World Health Assembly. It was titled "The Current and Future Role of Generic Medicines in Increasing Access to Treatment" and was held at the WHO headquarters to full capacity with multiagency participation. In welcoming participants to the meeting, Dr. Lembit Rago, EMP's Coordinator for Quality and Safety in Medicines, stated that generic medicines have a very important role to play in the future. Austerity measures in European countries have led to increased reliance and use of generics in view of their cost-saving potential. "The role of generic medicines will continue to be very important for years to come," he emphasised. In his introductory remarks, Dr. Philippe Duneton, Deputy Executive Director of UNITAID, explained how UNITAID's business model is providing access to generic medicines by focusing on generics manufacturers to lower prices and thereby increase access to treatment. He reiterated, "Without the WHO Programme, there will be limited capacity for work. The programme has, in fact driven the harmonisation process." He further stated that there were many challenges ahead. "Generic formulations, for example, may be difficult to assess and challenge," he warned. "Today is a good opportunity to prepare a ‘To-do List'," he stated. Following Dr. Duneton's introduction, Dr Rago's presentation focused on the WHO's Prequalification of Medicines Programme (WHO-PQP) in which he described new aspirations given to the Health For All and the Non-Communicable Diseases agenda. "Both of these," he emphasised, "depend heavily on availability and accessibility of good quality essential medicines". In his slide entitled "Is quality of medicines still a big problem?", he showcased recent unnecessary deaths related to the use of poor quality medicines. WHO has an extensive collaborative network which includes working with regulators. Some of the key achievements of these collaborations include increased access to quality medicines. For example, in 2012, eight million people received HIV retroviral treatments of which 6.5 million were for women using prequalified medicines. Dr. Lembit also explained the benefits of prequalification to both regulators and industries in the region. "PQP is a powerful and effective mechanism to promote access to quality medicine," he said. In his concluding remarks, Dr. Lembit was emphatic: "PQP saves lives. PQP is not a replacement for national regulatory systems but a mechanism to promote access to quality medicines. The time of poor quality medicines for poor people should be over. Poor people deserve good quality medicine." Robert Matiru, Porfolio Manager at the Prequalification and Tuberculosis Projects, spoke on the role of WHO's PQP in establishing healthy markets, while Greg Perry, Executive Director at the Medicines Patent Pool, gave an overiew on The Medicines Patent Pool and WHO-PQP: expanding access to quality, generic antiretroviral medicines. (For details on slide presentations and additional supporting documents, please see: http://apps.who.int/prequal/) Hiiti B. Sillo, Director-General of the Tanzania Food and Drugs Authority, spoke about the challenges in national regulation of critically needed medicines in Tanzania. These included: Adequacy of legislation to address regulation requirements and mandates; management structures and processes; human resources capacity and resources; lack of a harmonised GMP requirement and inspection procedure amongst regulators in importing and exporting countries and within the same region; market control which includes inspecting all assignments/imported batches. In his presentation on "The need for generic policies as part of health reform", Dr. Richard Laing, Medical Officer of the Medicine Programme, EMP, indicated that every country has a different generics market, and that no two countries are the same. Even after a patent expires, branded medications retain a sizeable volume of shares in some countries. What is critical is that all of the drugs, whether generics or branded, must be of the same quality. Countries vary in their generics uptake. For example, in the US, generics capture more than 80% of a brand's volume within six months. (In Germany, brand erosion is not so obvious, somewhere between 15-16% over a 4-5 year period whereas in Austria, it is estimated that erosion is between 4-5% over a 4-5 year period.) In conclusion, in all except high-income countries, out-of-pocket payment is the most frequent mode of payment for medicines. In those countries that have/or are in the process of introducing health insurance coverage which extends to medicines, clearly generic medicines' policies have an important role to play. "Where people have to pay out-of-pocket, generics policies will allow individual patients to reduce costs by up to 60% and this could make the difference between death or impoverishment and survival," said Laing. – Third World Network Features. -ends-
The above article is reproduced from the South-North Development Monitor (SUNS) #7592, 28 May 2013. When reproducing this feature, please credit Third World Network Features and (if applicable) the cooperating magazine or agency involved in the article, and give the byline. Please send us cuttings. And if reproduced on the internet, please send the web link where the article appears to twnet@po.jaring.my. 3967/13
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