Changes in the health sector in South Africa have been widespread since 1994 with restructuring ofthe public sector being the focal point of legislation. The limelight has recently shifted focus to the health sector with the Medicine and Related Substances (MRSCA) Amendment Act, 59 of 2002 in which generic substitution was finally promulgated, after disputes in the international arena about patent rights, due to the government's policy on parallel imports. Section12 ofPharmacy Act 90, which forms part of the Act is an attempt to further regulate the industry, that eventually became effective this year. This legislation addresses issues of sampling and perverse incentives and calls for the establishment of a Marketing Code for the pharmaceutical industry. The South African government has, as part of the amendment, called for input from all stakeholders including: trade associations, the pharmaceutical industry and the medical profession. All role players were invited to be part of the decisionmaking process as to what should constitute the Marketing Code and its' regulatory body. The Society of Psychiatrists (SASOP), an affiliate of the South African Medical Association (SAMA), has not yet prepared a response to SAMA for submission to government with regard to the Marketing Code, in the field of central nervous system (CNS) products. The impact of the banning of samples on psychiatric private practice is not known and there is insufficient data available about the marketing activities of drug companies and the link to the prescription habits of medical professionals. Further, to date, there has been no canvassing of opinions with regard to the impact of the legislation on the consumer. In this case study analysis, an evaluation of the impact of legislative changes in the South African pharmaceutical industry is made. Recommendations as to what should constitute a Marketing Code for the pharmaceutical industry are highlighted. restructuring ofthe public sector being the focal point of legislation. The limelight has recently shifted focus to the health sector with the Medicine and Related Substances (MRSCA) Amendment Act, 59 of 2002 in which generic substitution was finally promulgated, after disputes in the international arena about patent rights, due to the government's policy on parallel imports. Section12 ofPharmacy Act 90, which forms part of the Act is an attempt to further regulate the industry, that eventually became effective this year. This legislation addresses issues of sampling and perverse incentives and calls for the establishment of a Marketing Code for the pharmaceutical industry. The South African government has, as part of the amendment, called for input from all stakeholders including: trade associations, the pharmaceutical industry and the medical profession. All role players were invited to be part of the decisionmaking process as to what should constitute the Marketing Code and its' regulatory body. The Society of Psychiatrists (SASOP), an affiliate of the South African Medical Association (SAMA), has not yet prepared a response to SAMA for submission to government with regard to the Marketing Code, in the field of central nervous system (CNS) products. The impact of the banning of samples on psychiatric private practice is not known and there is insufficient data available about the marketing activities of drug companies and the link to the prescription habits of medical professionals. Further, to date, there has been no canvassing of opinions with regard to the impact of the legislation on the consumer. In this case study analysis, an evaluation of the impact of legislative changes in the South African pharmaceutical industry is made. Recommendations as to what should constitute a Marketing Code for the pharmaceutical industry are highlighted. / Thesis (MBA)- University of Natal, 2003.

Doctorat en sciences pharmaceutiques / info:eu-repo/semantics/nonPublished

The thesis explores the various instances in which pharmacists may incur delictual liability for harm suffered by their patients or third parties. As such, it is primarily concerned with the field of professional negligence. The work focuses specifically on the wrongfulness, fault and causation enquiries in pharmacy malpractice cases. The discussion is set against the backdrop of the pharmacy profession's shift towards patient-orientated service in recent years and explores whether this change in the profession's social role has had any effect on the legal duties and standard of care to which pharmacists are currently bound. It is argued that, in light of the dangers posed by modern medicines and the extent to which pharmacists are professionally expected to involve themselves in patient care, pharmacists can no longer escape liability simply by accurately dispensing pharmaceutical products. Rather, they are expected to participate actively in avoiding drug-related injury by, for example, providing patient counselling, detecting invalid or erroneous prescriptions and monitoring prescription refills. Although the thesis places particular emphasis on the role of pharmacists in achieving risk management, it also argues that pharmacists are, in very limited circumstances, required to participate in the risk assessment process traditionally thought to fall exclusively into the realm of physicians. It is furthermore demonstrated that pharmacists can incur liability regardless of whether a patient's harm can also be partially attributed to the blameworthy conduct of another healthcare professional. Although the thesis concludes that pharmacists are currently exposed to greater risks of liability than they were in the past, it also shows that plaintiffs who seek damages from pharmacists will usually experience a number of difficulties in establishing liability. In particular, problems are likely to be encountered in satisfying a court as to the presence of factual causation, which is notoriously difficult to establish in drug-related cases.

No description available.

Introduction: Due to the increase in healthcare costs, generic medicines have been adopted for used in both developed and developing countries. When a generic or ‘multisource interchangeable medicine’ is to be registered, studies that prove that the generic is equivalent to the Innovator Product (IP) are used. The generic medicine is required to prove that it will mirror the IP in terms of safety, quality and efficacy and, in South Africa, the Medicines Control Council (MCC) ensures that generic medicines meet these requirements. Generic medicines may be registered using bioequivalence data obtained from comparison with a domestic reference product (usually the local innovator product) or in certain cases, a foreign reference product (FRP). The bioequivalence data can either be from in vivo or in vitro studies. The MCC guidelines require that for modified release preparations, in vivo bioequivalence studies are done for approval of registration; the exception being if a proportionally higher dose has already been registered. No information is currently given to prescribers and dispensers or to the public about whether a generic product was registered against a foreign or domestic reference product. Aims and Objectives: 1.) To determine the number of generic medicines in a predetermined sample registered using a FRP as comparator and to document the transparency of pharmaceutical companies when approached to disclose information regarding the registration of these products. 2.) To describe and document the use of the Promotion of Access to Information Act (Act 2 of 2000) [PAIA] from the perspective of a ‘layperson’ in the context of medicines’ regulation, in both private and public bodies. Methods: 20 modified release and Biopharmaceutics Classification System (BCS) class IV products were selected from the ‘generics dictionary’ – a commercial publication – and letters were sent to the manufacturers of the products requesting information about the tests done to prove equivalence and whether they were performed against a domestic or foreign reference product. The same information was also requested from the MCC. The requests were all made using the Promotion of Access to Information Act (PAIA). Results: Nine companies were represented by the 20 products chosen. Information was obtained about thirteen products. Ten of these products were registered using FRPs. Four products were registered based only on comparative dissolution studies. Four companies provided the requested information, two companies responded by refusing the requests and three did not respond at all. The MCC refused the request for information even after an internal appeal was lodged. Conclusions: The Promotion of Access to information Act was unsuccessful in obtaining information from the public body, and partly successful in obtaining it from the private bodies. While the title of the Act seems to indicate that the Act can be used to obtain information as such, it only provides for access to specified records. The MCC and the pharmaceutical companies involved in the study were under no obligation to provide the information as the request had not complied with PAIA requirements. The use of FRPs for registration is a reality in the pharmaceutical industry in South Africa. Neither the public nor healthcare professionals who prescribe medicines or who are involved in dispensing generic medicines as substitutes are aware of whether or not a FRP has been used to register a generic. Interchangeability cannot necessarily be guaranteed if the reference product was not proven equivalent to the local innovator product. It is debatable as to whether or not this information would be of any particular benefit to members of the public. Prescribers may choose to write ‘no substitution’ on their prescriptions if they were unconvinced that an FRP is acceptable. This could have consequences for healthcare costs. Dispensers are the most vulnerable in South Africa as they are obliged by law to substitute generic medicines when innovator medicines have been prescribed. Dispensers’ views on the acceptability of the use of FRPs can be seen as irrelevant. In the end, as this study demonstrates, the only option in the present situation is to rely entirely on the MCC’s rigour in assessing applications for registration of generic medicines.

The purpose of this study was to develop a framework for provision of essential medicines for the district health services. A qualitative descriptive, exploratory and contextual action research design was followed. The data collection was conducted through site visits and semi structured interviews targeting the responsible pharmacists who were purposively selected on the basis of their expert knowledge and experiences from the eight of the nine provinces of the Republic of South Africa which is a developing country with limited resources for provision of healthcare services. The study found that there was no standardised framework for provision of essential medicines for the District Health Services. Based on the site visits and action research findings a proposed framework covering the selection, procurement, warehousing, distribution and management support components for provision of essential medicines for district health services was developed and subjected to national pharmaceutical experts and district health services managers review and critique which is finally presented, after taking into consideration the experts inputs as a proposed framework emanating from the study. The proposed framework will contribute towards improving the provisioning and availability of essential medicines within the district health services. / Health Studies / D.Litt. et Phil. (Health Studies)

In 2001 the Declaration on the TRIPS Agreement and Public Health (‘Doha Declaration’), affirmed the right of member states of the World Trade Organisation (‘WTO’) to interpret and implement the TRIPS Agreement as supportive of the protection of public health and, in particular, access to medicines. While initially well-received, consternation soon arose over the interpretation of a specific paragraph in the Doha Declaration dealing with compulsory licensing. After a further two years of deliberation, the WTO Decision on the Interpretation of Paragraph 6 (‘Paragraph-6 Decision’) was announced in August 2003 specifying when countries can import drugs produced elsewhere under compulsory licence. With one third of the world's population is still denied access to essential medicines - a figure which rises to over 50 per cent in Asia and Africa - the problems facing the public health community are two-fold. The first is the capacity of developing countries (‘DCs’) actually to use the flexibilities afforded under the TRIPS Agreement, the Doha Declaration, and the Paragraph- 6 Decision amid stark inequalities in health resources and the world trading system as a whole. These include provisions for compulsory licensing, parallel importation, and addressing imbalances in research and development (‘R&D’). The pending ratification of the Paragraph-6 Decision, from an interim solution to a permanent amendment, is accompanied by considerable uncertainty: will the protections be accessible under the system currently proposed? The second problem concerns the undermining of the above hard-won flexibilities by provisions adopted under various bilateral and regional trade agreements. Known as ‘TRIPS-plus’- or ‘WTO-plus’- measures, the level of intellectual property rights (‘IPRs’) rights protection being negotiated and even adopted under other trade agreements are more restrictive as regards public health protection. These two sources of concern have led to an increase in rather than a lessening of tensions between the public health and trade policy communities. The thesis opens with a brief analysis of the interplay between patents and medicines. This includes an overview of the human rights framework and the right of access to medicines as a manifestation of human rights. The historical development of the TRIPS Agreement, its legitimacy, and the effect of the introduction of patents for pharmaceuticals are critically analysed. The terms of the Doha Declaration as it relates to public health, the Paragraph-6 Decision and its system, the December 2005 Amendment, and the progress made to date on the public health protections available under the TRIPS Agreement are reviewed and discussed in detail. The thesis describes how, despite these important clarifications, concerns as to the capacity of DCs to implement specific measures persist. This thesis further addresses the development of compulsory licensing in India and South Africa, and the legal framework for compulsory licensing in these countries. The role of competition law and constraints faced by DCs in implementing the flexibilities offered by the TRIPS Agreement and Doha Declaration are considered before turning to the threat posed by TRIPS-plus measures and calls for their critical reassessment. The thesis considers the role of the Intergovernmental Working Group on Public Health, Innovation and Intellectual Property (IGWG), the WHO Commission on IPRs, Innovation and Public Health (CIPIH), Patent Pools, and international and multilateral donors in access to medicines. The thesis concludes by reviewing potential ways forward to ensure that access to medicines by the poor living in DCs is secured in all trade agreements. / Mercantile Law / LL.D.

In 2001 the Declaration on the TRIPS Agreement and Public Health (‘Doha Declaration’), affirmed the right of member states of the World Trade Organisation (‘WTO’) to interpret and implement the TRIPS Agreement as supportive of the protection of public health and, in particular, access to medicines. While initially well-received, consternation soon arose over the interpretation of a specific paragraph in the Doha Declaration dealing with compulsory licensing. After a further two years of deliberation, the WTO Decision on the Interpretation of Paragraph 6 (‘Paragraph-6 Decision’) was announced in August 2003 specifying when countries can import drugs produced elsewhere under compulsory licence. With one third of the world's population is still denied access to essential medicines - a figure which rises to over 50 per cent in Asia and Africa - the problems facing the public health community are two-fold. The first is the capacity of developing countries (‘DCs’) actually to use the flexibilities afforded under the TRIPS Agreement, the Doha Declaration, and the Paragraph- 6 Decision amid stark inequalities in health resources and the world trading system as a whole. These include provisions for compulsory licensing, parallel importation, and addressing imbalances in research and development (‘R&D’). The pending ratification of the Paragraph-6 Decision, from an interim solution to a permanent amendment, is accompanied by considerable uncertainty: will the protections be accessible under the system currently proposed? The second problem concerns the undermining of the above hard-won flexibilities by provisions adopted under various bilateral and regional trade agreements. Known as ‘TRIPS-plus’- or ‘WTO-plus’- measures, the level of intellectual property rights (‘IPRs’) rights protection being negotiated and even adopted under other trade agreements are more restrictive as regards public health protection. These two sources of concern have led to an increase in rather than a lessening of tensions between the public health and trade policy communities. The thesis opens with a brief analysis of the interplay between patents and medicines. This includes an overview of the human rights framework and the right of access to medicines as a manifestation of human rights. The historical development of the TRIPS Agreement, its legitimacy, and the effect of the introduction of patents for pharmaceuticals are critically analysed. The terms of the Doha Declaration as it relates to public health, the Paragraph-6 Decision and its system, the December 2005 Amendment, and the progress made to date on the public health protections available under the TRIPS Agreement are reviewed and discussed in detail. The thesis describes how, despite these important clarifications, concerns as to the capacity of DCs to implement specific measures persist. This thesis further addresses the development of compulsory licensing in India and South Africa, and the legal framework for compulsory licensing in these countries. The role of competition law and constraints faced by DCs in implementing the flexibilities offered by the TRIPS Agreement and Doha Declaration are considered before turning to the threat posed by TRIPS-plus measures and calls for their critical reassessment. The thesis considers the role of the Intergovernmental Working Group on Public Health, Innovation and Intellectual Property (IGWG), the WHO Commission on IPRs, Innovation and Public Health (CIPIH), Patent Pools, and international and multilateral donors in access to medicines. The thesis concludes by reviewing potential ways forward to ensure that access to medicines by the poor living in DCs is secured in all trade agreements. / Mercantile Law / LL.D.