Quality of medicines : deficiencies found by Brazilian Health Regulatory Agency (ANVISA) on good manufacturing practices international inspections

The circulation of poor quality medicines, especially in the developing countries, is a public health concern. Compliance with good manufacturing practices (GMP) is essential to ensure the quality, efficacy, and safety of medicines. This study evaluated the outcomes of the Brazilian Health Regulatory Agency's (ANVISA) international inspections of two years (2015 and 2016) and compared these to those of other regulatory authorities. The information from 255 inspection reports was analyzed, and the type and extent of deficiencies were collected. In the period evaluated, 62.75% of ANVISA-inspected companies were classified as GMP ªsatisfactory,º 24.71% were classified as having ªon demandº status, and 12.55% of inspections concluded that the company did not comply with Brazilian GMP regulations (ªunsatisfactoryº). The most common areas of deficiency were documentation (28.63%) and premises (26.27%). The pattern of deficiencies was similar to the findings of other regulatory agencies. However, ANVISA detected a more significant number of non-compliance results than other authorities, which may be caused by differences in classifications adopted by each Agency. Furthermore, manufacturers inspected by ANVISA may follow different standards and practices for products manufactured for the Brazilian market. Disclosure of main GMP deficiencies found can be useful for encouraging the industry to comply with GMP, and additional guidelines in the specific areas where deficiencies are often identified may be useful to industry to improve GMP compliance. Harmonization of GMP guidelines and inspection procedures are the key steps to avoid duplicate work, but regulatory authorities also need to work together to enforce the proper level of GMP compliance by pharmaceutical manufacturers, assuring high quality and safe medicines supply

Introducing Inventiveness into the Patent System: Submission to the Review of the National Innovation System

Because of the potential impact of the patent system on innovation diffusion, particularly on continuous and/or incremental innovation, patent policy should be of central importance to the review of the national innovation system. Substantial empirical evidence shows that most industrial innovations are not induced by the patent system. Even in very large markets, such as the USA, only a minority of patents are likely to be induced by the patent system. To the extent that patents do induce innovations, it is the inventiveness of the innovation which gives rise to possible social benefits (externalities, mainly in the form of knowledge spillovers) which may offset the costs of a patent system and thus give rise to a net economic benefit. On the basis of this evidence about the inducement effect of the patent system, and evidence on the current very low inventiveness standard for patent grant, policy proposals are put forward to re-introduce inventiveness into the patent system, thus making it potentially welfare-enhancing. These proposed changes would also have a major impact in ameliorating the negative impact of the patent system on continuous/incremental innovation

Knowledge Management in the Pharmaceutical Industry: Between Academic Research and Industry Regulations

The pharmaceutical sector is one of the pillars of the world’s economy. A significant proportion of its value lies in intellectual assets generated through continuous innovation and lengthy development cycles within a strictly regulated environment. The purpose of this paper is to address the gap between knowledge management (KM) as an expanding academic discipline in the pharmaceutical industry and at the same time a growing regulatory expectation. A systematic review of 137 refereed KM articles revealed six empirical research themes in the pharmaceutical industry. In a subsequent step, the discovered themes and subthemes were compared with the extant regulatory expectations as explained in 128 regulatory guidelines. Findings shed the light on the gap between academic KM research and the current thinking of regulatory bodies. Some regulated knowledge processes were underrepresented in academic literature. The paper offers also novel insights and recommendations for future developments in academic research, regulations and/or industry

What can IBSA Offer to the Global Community?

What can IBSA offer to the global community? It is with this provocative question that IPC-IG reports on the policy dialogue that took place in the Fourth IBSA Academic Forum, which was held on 12-13 April 2010 in Brasilia before the meeting of the heads of state. If IBSA reflects a new power structure in which the Global South has more voice, then it also can and should contribute to the global development debate. The three countries have been successfully experimenting with innovative policies in areas such as healthcare and social protection, as well as in development cooperation through IBSA?s Fund for Alleviation of Poverty. This issue of Poverty in Focus brings together articles by speakers on the four panels organized. They address the role of non-contributory cash transfers and employment programmes, the debates on healthcare innovation, intellectual property rights and access to essential drugs, and the discussions about IBSA?s role and potential as a plurilateral arrangement. Lyal White starts by taking stock of IBSA?s progress in the seven years since it was launched in 2003. He argues that, given the economic crisis, IBSA?s role can be more relevant than ever. It has made significant progress on political coordination and development cooperation, though the substance in the working groups remains a challenge. Fábio Soares and Radhika Lal take an integrative approach to social development, linking cash transfers and employment programmes with a view to addressing vulnerability across the life cycle. The IBSA countries offer a good example of rights-based frameworks, and have a vision of moving beyond schemes to more comprehensive systems. Amita Sharma describes the National Rural Employment Guarantee Act (NREGA) and emphasises the legal approach whereby NREGA is seen as a service provided by the government, an entitlement that involves public scrutiny and participation at a local level. NREGA has links to other policy areas, revealing the potential for integration that has been the great challenge of social policy in India. Ingrid Woolard discusses how South Africa?s Unemployment Insurance Fund is limited. She argues for greater integration between social assistance and labour-market policies. There is still no coherent system in place, and the fiscal sustainability of these policies will be a major concern as the country confronts a tougher growth environment. Sergei Soares shows the differences between taking account of a transversal definition of income (income in a given month) and a longitudinal one (income during the next 24 months) when calculating the targets for Brazil?s Bolsa Família. The longitudinal poverty rate is about twice the transversal poverty figure, thus explaining the mismatch between the targets and the eligible population. Radhika Lal gives an overview of the discussions on healthcare and points to problems in the field of trade-related intellectual property rights. Potential areas for collaboration between the IBSA countries include sharing information on drug prices and on sources of low-cost drugs, as well as research and development for drugs that treat neglected diseases. Biswajit Dhar and Reji Joseph express their concern for the weak legal distinction between substandard medicines and counterfeit drugs. Since laws on the matter apply to both branded and generic drugs, there is a risk of equating authorised generics with counterfeit products. This could disrupt the trade in generics and thus hamper access to crucial life-saving medicines in the Global South. Kamal Mitra Chenoy argues that plurilateralism in arrangements like IBSA can add value to multilateralism only if it can connect the excluded countries of the South to the blocs of the North. He also argues that plurilateralism is valuable if it goes beyond the interests of capital and helps create a people-centred development paradigm. Alcides Costa Vaz closes this Poverty in Focus with a discussion of the different approaches taken by each of the IBSA countries. As a flexible mechanism, however, IBSA should be able to accommodate the different perspectives. There is a follow-up to this debate. For more information, visit www.ipc-undp.org.What can IBSA Offer to the Global Community?