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AbstractIt is a vast understatement to say that the problem of access to medicines in developing countries is complex. Access is limited by a range of factors including inability to pay, a lack of infrastructure, and corruption in some countries. Surrounding and exacerbating these structural and technological problems is the layer of legal rights created by patents and their licensing that complicate and render more expensive the preparation and delivery of needed medicines, particularly those that need to be adapted to the social, health and cultural environment of developing countries. This article provides a survey of innovative strategies that aim at maximizing the potential of patents to facilitate the development and delivery of medicines against diseases, the burden of which falls principally on developing country populations. To understand the context in which these strategies are being proposed and implemented, the article reviews the battles over access to medicines beginning in the late 1980s. It then surveys some of the principal suggestions put forward to better direct innovation systems in addressing the critical health needs of the world's majority including advance market commitments, patent buy‐outs, prize funds, public–private partnerships and patent pools.

It is a vast understatement to say that the problem of access to medicines in developing countries is complex. Access is limited by a range of factors including inability to pay, a lack of infrastructure, and corruption in some countries. Surrounding and exacerbating these structural and technological problems is the layer of legal rights created by patents and their licensing that complicate and render more expensive the preparation and delivery of needed medicines, particularly those that need to be adapted to the social, health and cultural environment of developing countries. This article provides a survey of innovative strategies that aim at maximizing the potential of patents to facilitate the development and delivery of medicines against diseases, the burden of which falls principally on developing country populations. To understand the context in which these strategies are being proposed and implemented, the article reviews the battles over access to medicines beginning in the late 1980s. It then surveys some of the principal suggestions put forward to better direct innovation systems in addressing the critical health needs of the world's majority including advance market commitments, patent buy-outs, prize funds, public-private partnerships and patent pools. © 2012 London School of Economics and Political Science and John Wiley & Sons Ltd. ; SCOPUS: ar.j ; FLWNA ; info:eu-repo/semantics/published

PharmD ; Access to safe, effective and good quality medicines is an evolving, complex and multifactorial challenge which has significant impact on public health and may contribute to health inequalities. This research aimed to develop a rational and prompt medicines accessibility framework. The objectives related to enhancing access to medicines were to: 1 Analyse retrospective queries and 2 Propose a framework to deal with access issues. The methodology involved two stages: 1 Analysing retrospectively access queries recorded at the Medicines Intelligence and Access Unit within the Malta Medicines Authority. A focus group was set up to identify patient-related barriers to access medicines and to develop a risk-based approach to assess lack of access alongside patient medicines needs. 2 Devising an innovative framework to enhance access to medicines by acquiring medicines intelligence and analysing real case scenarios. Observations and corresponding results progressed across the two stages: 1 All the 480 retrospective queries recorded at the Medicines Intelligence and Access Unit over a 60-month period (June 2014 and June 2019) were analysed. The focus group classified the access queries into four categories which were identified as barriers to access medicines: (i) safety (n=201, 42%) (ii) availability (n=143, 30%), (iii) pharmacoeconomic (n=97, 23%) and (iv) shortages (n=39, 8%). A risk-based approach was adopted to assess the outcomes of the access issues on patient medicines needs. The focus group recommended to classify risk by drawing on the classification of findings of the Good Manufacturing Practice quality management system and categorise risk as critical, major and other. 2 A scientific framework based on risk identification, access implications and medicines intelligence was devised to address access issues. Medicines intelligence on access issues was acquired through participation in fora and communication with the patient. Two hundred and nineteen critical risk access queries were evaluated through case scenarios in line with the category of barriers to access which was identified. Critical risk related to safety was due to adverse effects related to the change of the medicinal product manufacturer such as a generic or biosimilar medicine (n=12, 5.5%) and contamination of active pharmaceutical ingredients with nitrosamine impurities (n=175, 79.9%). The latter was associated with a disruptive occurrence and was identified as an outlier. Availability issues were critical when the medicine was not marketed (n=8, 4%) or not listed on the Government Formulary List (n=3, 1.4%). Pharmacoeconomic issues, classified as critical (n=4, 1.8%), were associated with the high cost of medicines. Critical risk related to shortages occurred due to disruptions in the supply chain (n=15, 6.8%) and withdrawal of the marketing authorisation (n=2, 0.9%). For each case scenario, patient-centered medicines intelligence interventions were recommended such as the proposal of a standard operating procedure for the inpatient pharmacy to prepare extemporaneous preparations of adrenaline injections instead of commercially unavailable adrenaline autoinjectors. An innovative framework to detect, address and mitigate access issues based on medicines intelligence and risk identification was developed to proactively enhance access to medicines in a personalised care approach. ; N/A

Until recently, the link between the examination of patents carried out by national patent offices and the right of citizens to access to medicines was not at all clear. They were two functions or responsibilities of the State that apparently had nothing to do with each other. Examining the growing literature on intellectual property and access to medicines, it seems that the analysis of one actor has been left out: the patent offices. And the reason is clear: patent offices are administrative institutions. Patentability requirements are not defined by patent offices, but frequently by the courts, tribunals, legislation or treaty negotiators. There is now greater understanding that the examination of patents and the role played by patent examiners are key elements that could contribute to or obstruct access to medicines. Given the impact of pharmaceutical patents on access to medicines, patent offices should draw up public policies and strategies that respond to national health and medicine policies.

Introduction -- Patent policy, access to medicines, and the regulatory theory of patent rights -- The interface between patent rights and the right to health under international human rights law -- Incorporating a model of human rights into the adjudication of pharmaceutical patent cases (part one) : Kenya as a case study -- Incorporating a model of human rights into the adjudication of pharmaceutical patent cases (part two) : South Africa as a case study -- Incorporating a model of human rights into the adjudication of pharmaceutical patent cases (part three) : India as a case study -- Conclusion.

In this paper we document a process of price convergence in the European market for pharmaceuticals and relate it to access to innovative medicines in individual countries. The EU is a peculiar case study, where free circulation of goods exists, but pricing policies are designed and implemented by Member States. Thanks to a unique census database on product sales and launches for fifteen EU countries, we detect a process of price convergence, both in nominal and in real terms. Therefore, we find that a faster rate of price convergence and a lower income per capita are associated with stronger delays in launches of new medicines. Moreover, country delays tend to be higher for innovative and first in class chemical compounds. Our results suggest that inefficiencies arise from drugs regulation, when countries widely differ in income per capita, public finance sustainability conditions, and regulatory frameworks. Policies of external reference pricing tend to exacerbate welfare losses. A policy of differential pricing is suggested, in order to take into account both therapeutic value and willingness to pay.