The politics of the pharmaceutical industry and access to medicines : world pharmacy and India

The Pharmaceutical Industry presents one of India’s most successful stories of economic expansion and improvements in public health. Indian firms have made access to quality medicines possible and affordable in many developing countries. Indian pharmaceuticals are also exported on a large scale to the United States and other highly regulated markets. A wave of mergers, acquisitions and tie-ups point to growing integration between Indian firms and global pharma multinationals.

The Politics of the Pharmaceutical Industry and Access to Medicines: World Pharmacy and India examines this important industry from different economic, social and political perspectives. Topics covered include the implications of TRIPS-compliant intellectual property rights, the role of flexibilities under TRIPS, the market regulation system, the role of Indian firms in exporting HIV/AIDS medications to Africa, the issue of free trade agreements, the power and reach of foreign pharmaceutical multinationals in India’s domestic market, and the sustainability of India as a major generics supplier.

The Pharmaceutical Industry and Access to Medicines in India

Pharmaceutical policy in India as elsewhere is shaped by conflicting economic and social interests and opposing values and priorities. Tensions can be understood as revolving around the contradiction between use value and exchange value in the production of medicinal drugs as commodities, as per Marx’s original analysis. The use value of medicines – if safe and efficacious, of good quality, and prescribed and consumed appropriately – is the prevention, cure or alleviation of ill-health and disease. Health policy is – or should be – aimed at optimising the use value of medicines. For this purpose government agencies administer regulatory oversight of the manufacturing, marketing and distribution of medicines. Drugs made available to patients are expected to meet adequate safety, quality and efficacy standards, but regulation to ensure such standards is subject to controversy in most countries. This is a domain where definition and interpretation of scientific-technological principles and criteria is infused by partiality and bias grounded in social and material interests, as evidenced by recurrent debates about industry ‘capture’ of regulatory agencies, including the world’s most regulator, the US Food and Drug Administration (Angell 2005; Law 2006). In India, a Parliamentary Committee Report in 2012 depicted the Central Drugs Standard Control Organisation (CDSCO) as dysfunctional and influenced inappropriately by the exchange value perspective of manufacturers (Parliamentary Standing Committee on Health and Welfare 2012). The clash between use and exchange value perspectives is starkly illustrated by cases of products known to cause more harm than good, particularly common in poorly regulated markets such as India’s, as shown by Srinivasan & Phadke.

Access to information about donors by donor-conceieved individuals : a human rights analysis

While assisted reproductive treatment using donated gametes is widespread, and in many places, widely accepted, it has historically been shrouded in secrecy. Over time, however, there has been an increasing call from donor-conceived people, recipient parents and some donors to end the secrecy, and to release identifying information about donors to donor-conceived people. "Rights-based" arguments have at times been used to justify this call. This article examines whether a human rights framework supports the release of information and how such a framework might be applied when there are competing rights. It argues that the current balancing approach used to resolve such issues weighs in favour of release. Legal action has the potential to be legitimate and justifiable. A measure such as a contact veto system, which would serve to prevent unwanted contact with the person lodging the veto (either the donor or the donor-conceived person), would ensure proportionality. In this way, both donor-conceived people's rights to private life, identity and family, and donors' rights to privacy may be recognised and balanced.

An efficient solution for privacy-preserving, secure remote access to sensitive data

Sharing data that contains personally identifiable or sensitive information, such as medical records, always has privacy and security implications. The issues can become rather complex when the methods of access can vary, and accurate individual data needs to be provided whilst mass data release for specific purposes (for example for medical research) also has to be catered for. Although various solutions have been proposed to address the different aspects individually, a comprehensive approach is highly desirable. This paper presents a solution for maintaining the privacy of data released en masse in a controlled manner, and for providing secure access to the original data for authorized users. The results show that the solution is provably secure and maintains privacy in a more efficient manner than previous solutions.

The pharmaceutical industry, intellectual property rights and access to medicines in Pakistan

The pharmaceutical industry in Pakistan is worth around US$ l.18 billion, with annual growth in 2010 approaching 10 per cent (Khan, 2012). There are more than 650 registered companies, including 31 multinationals, which in 2006 had a market share in value terms of 53.3 per cent, with national firms controlling the remaining 46.7 per cent (IMS Health, 2007). In 2007 medicines worth about US$100 million were exported. Medicines are a vital component of healthcare, and Pakistan spends around three-quarters of its healthcare budget on medicines (WHO, 2004). This chapter provides an overview, from a public health perspective, of the national pharmaceutical market and the development of drug policies and regulation. Pakistan adopted a Trade Related Aspects of Intellectual Property Rights (TRIPS) compliant patent regime in 2000, and the intersection between patents and public health is a central policy challenge. This chapter highlights key issues related to intellectual property, Free Trade Agreements (FTAs), and production and access to medicines.

Access to Health-Promoting Facilities and Amenities

This chapter provides a brief overview of the existing literature on the importance of the built environment to obesity and examines how local facilities, such as physical activity amenities, are distributed across different sorts of neighbourhoods. The issue of access to these facilities using different forms of transport (walking, cycling, bus or car) is explored using data from a Scotland wide study.

Sociospatial distribution of access to facilities for moderate and vigorous intensity physical activity in Scotland by different modes of transport

Background People living in neighbourhoods of lower socioeconomic status have been shown to have higher rates of obesity and a lower likelihood of meeting physical activity recommendations than their more affluent counterparts. This study examines the sociospatial distribution of access to facilities for moderate or vigorous intensity physical activity in Scotland and whether such access differs by the mode of transport available and by Urban Rural Classification. Methods A database of all fixed physical activity facilities was obtained from the national agency for sport in Scotland. Facilities were categorised into light, moderate and vigorous intensity activity groupings before being mapped. Transport networks were created to assess the number of each type of facility accessible from the population weighted centroid of each small area in Scotland on foot, by bicycle, by car and by bus. Multilevel modelling was used to investigate the distribution of the number of accessible facilities by small area deprivation within urban, small town and rural areas separately, adjusting for population size and local authority. Results Prior to adjustment for Urban Rural Classification and local authority, the median number of accessible facilities for moderate or vigorous intensity activity increased with increasing deprivation from the most affluent or second most affluent quintile to the most deprived for all modes of transport. However, after adjustment, the modelling results suggest that those in more affluent areas have significantly higher access to moderate and vigorous intensity facilities by car than those living in more deprived areas. Conclusions The sociospatial distributions of access to facilities for both moderate intensity and vigorous intensity physical activity were similar. However, the results suggest that those living in the most affluent neighbourhoods have poorer access to facilities of either type that can be reached on foot, by bicycle or by bus than those living in less affluent areas. This poorer access from the most affluent areas appears to be reversed for those with access to a car.

Challenges redoubled: contexts of risk and compromised access to services for children with sexualised behaviours

 Clinical studies indicate that children who engage in coercive or aggressive sexual acts are more likely to come from conditions of developmental adversity. Broadly speaking, the context of risk for children engaging in these behaviours aligns with particular indicators of social exclusion; geographic disadvantage, compromised family functioning and poverty. Children from such conditions of adversity are thought to be doubly compromised, as the context of risk that gave rise to the behaviours may also compromise families’ engagement with specialised therapeutic services to modify a child’s behaviours. In the absence of empirical data on the prevalence of problem sexual behaviours in Australia, this paper suggests that that scholarship and data collection underpinning the social inclusion policy agenda may inform the targeted delivery of secondary prevention strategies for children most at risk of engaging in problem sexual behaviours.