What is the impact of intellectual property rules on access to medicines? A systematic review.

BACKGROUND: It is widely accepted that intellectual property legal requirements such as patents and data exclusivity can affect access to medicines, but to date there has not been a comprehensive review of the empirical evidence on this topic. The World Trade Organization's Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) requires Member States to implement minimum standards of intellectual property protection including patents for pharmaceutical products, but also contains 'flexibilities' designed to address barriers to access to medicines. National intellectual property laws can also include TRIPS-plus rules that go beyond what is required by TRIPS. We aimed to systematically review literature that measures the impact of intellectual property rules on access to medicines, whether implemented as a result of TRIPS, TRIPS-plus provisions in other trade agreements, or unilateral policy decisions. METHODS: We searched Proquest, SCOPUS, Web of Science, PubMed, JSTOR, Westlaw and Lexis Nexis. Peer reviewed articles, government reports and other grey literature were included. Articles were eligible for inclusion if they were quantitative, in English, included a measure of cost, price, availability of or access to medicines, were about intellectual property or data exclusivity rules and published between January 1995 and October 2020. Ninety-one studies met our inclusion criteria. We systematically reviewed the studies' findings and evaluated their quality using a modified quality assessment template. RESULTS AND CONCLUSION: Five broad overarching themes and 11 subthemes were identified based on the articles' foci. They were: trade agreements (divided into EU FTAs and those that include the USA); use of TRIPS flexibilities (divided into compulsory licencing and parallel importation); patent expiry/generic entry/generic pathway (divided into comparative studies and single country studies); patent policies (also divided into comparative studies and single country studies) and TRIPS-plus rules (divided into data exclusivity, patent term extensions and secondary patenting). Most studies focused not on specific trade agreements, but on TRIPS-plus provisions, which can also be found within some trade agreements. The main finding of this review is that the stronger pharmaceutical monopolies created by TRIPs-plus intellectual property rules are generally associated with increased drug prices, delayed availability and increased costs to consumers and governments. There is evidence that TRIPS flexibilities can facilitate access to medicines although their use is limited to date. There were few studies that included resource poor settings, signalling a need for greater research in such settings where the impact on access to medicines is likely to be more damaging.

Sustainable Transition From Donor Grant Financing: What Could It Look Like?

Donor transition is an important aspect of sustaining the impact of donor investments after financial support has ceased. This article compares, contrasts, and critiques the transition policies of the top health donors in the Asia Pacific, which includes Global Fund to fight AIDS, tuberculosis, and malaria, Gavi-the Vaccine Alliance, World Bank (International Development Association), and the United States US Agency for International Development to gain a deeper understanding of what a sustainable financial transition could look like. A literature review of the academic and gray literature was undertaken to ascertain these donors' transition policies and to determine the success of these policies in ensuring sustainable and effective transition. It is proposed that sustainable transition requires a clearly articulated vision of long-term impact, explicit and transparent transition policies, clear time frames for transition, donor coordination, and evaluation of long-term impacts of donor withdrawal.

The Trans Pacific Partnership Agreement and access to HIV treatment in Vietnam.

In the Trans Pacific Partnership (TPP) Agreement negotiations, the USA successfully pursued intellectual property (IP) provisions that will affect the affordability of medicines, including anti-retrovirals (ARV) for HIV. Vietnam has the lowest GDP per capita of the 12 TPP countries and in 2013 provided ARVs for only 68% of eligible people living with HIV. Using the current Vietnamese IP regime as our base case, we analysed the potential impact of a regime making full use of legal IP flexibilities, and one based on the IP provisions of the final, agreed TPP text. Results indicate that at current funding levels 82% of Vietnam's eligible people living with HIV would receive ARVs if legal flexibilities were fully utilised, while as few as 30% may have access to ARVs under the TPP Agreement - more than halving the proportion currently treated.

Arresting HIV: Fostering Partnerships between Sex Workers and Police to Reduce HIV Risk and Promote Professionalization within Policing Institutions: A Realist Review.

In many countries around the world sex work is criminalised and its regulatory control is therefore often in the hands of the police. In addition to the impact of this criminalised legal environment, much literature describes the negative impact that certain police practices can have on the ability of sex workers and the programs that work with sex workers to access essential HIV prevention, treatment, care and support services. This situation has resulted in persistent concentrated HIV epidemics among sex workers in many countries of the world. The need for multi-sector partnerships between police and HIV programs is increasingly recognised in various UN declarations and resolutions yet descriptions of the process or key ingredients required to actually establish and sustain these necessary partnerships between police and sex workers [or the programs that provide essential services to sex workers] are sparse. The paper seeks to establish key considerations and critical processes that are required to foster partnerships that if further investigated and scaled up, could result in an enhanced enabling environment for the provision of essential HIV services for sex workers around the globe. This paper is based on a realist review that investigated isolated examples of partnership formation between law enforcement and HIV programs working with sex workers. This methodology research is designed to work with complex social interventions and is based on the emerging 'realist' approach to evaluation. A realist review methodology was chosen given the paucity of relevant literature in this vein and the authors' familiarity with the grey literature and relationships with experts who work in this sphere. The review found that political and police leadership, civil society strengthening and police reform in relation to HIV, are critical factors and key ingredients in changing the enabling environment in which sex work takes place to ensure that HIV prevention, individual and public health as well as HIV prevention and the promotion of human rights are the number one priority. Further research into this relationship is needed to provide evidence for effective HIV programming with police.

Barriers to and facilitators of adherence to antiretroviral therapy among people living with HIV in Lao PDR: a qualitative study.

Adherence to antiretroviral therapy (ART) is essential to its effectiveness and avoidance of the development of drug-resistant HIV strains. Many studies have been undertaken on factors affecting adherence to ART; however, there is little information about Laos. Hence, this qualitative study examines barriers to and facilitators of adherence specific to this context. In-depth interviews and focus group discussions were undertaken with 43 people living with HIV (PLHIV) currently on ART across 2 hospitals in Laos: Setthathirath hospital in the capital Vientiane and Savannakhet Province hospital. Interviews were based on semistructured question guides and were undertaken in Lao, translated into English and audio-recorded for later analysis. Major barriers to adherence reported by participants included transport costs, distance to the hospital, and stigma and discrimination. Key facilitators discussed were the perceived benefits of medication, social support, and the acceptance of HIV status.

Reasons for default from treatment of chronic illnesses in a primary healthcare program in rural Tamil Nadu.

Chronic illnesses are an increasing cause of morbidity and mortality in rural India. Many patients default from treatment, and exploring their reasons for the same may suggest strategies to improve service accessibility and acceptability. A qualitative study was conducted of 22 patient interviews, six key informant interviews, and two patient focus group discussions for investigating the reasons for default at the KC Patty Primary Health Centre and surrounding villages in Kodaikanal Taluk, Dindigul district, Tamil Nadu. The reasons included money or transport difficulties, frequent travel, feeling healthy, focus on work, fear of scolding from clinic staff, medication side effects, preference for alternative therapy, and depression. Some reasons were only divulged after an extended discussion. Support from families and village-level health workers (VLHWs) were also identified as important. Recommendations include more open and patient communication between health workers and defaulting patients, in addition to recruitment of more VLHWs.

Defining and redefining harm reduction in the Lao context.

The response to drug use in Laos has focused on reducing opium supply (supply reduction) and rates of drug use (demand reduction). However, recently there is increased interest among government counterparts to discuss and develop broader responses to injecting drug use (IDU) including the introduction of harm reduction programs. The concept of harm reduction has just been introduced to Lao PDR and as yet there is no agreement on a definition of the concept. We highlight here a range of issues that remain controversial in Lao PDR in the HIV, drug use and harm reduction discourse, the definition of 'harm reduction' and related terms; and the scope of harm reduction.This was a qualitative study, consisting of in-depth interviews with 27 law enforcement and 8 health officers who work in the fields of HIV and/or drug control about their understanding of HIV related to drug use, and concepts of harm reduction. Content analysis was performed to identify the coding, categories and themes.We found that law enforcement officers in particular had limited understanding about harm reduction and the feasibility and appropriateness of harm reduction services in the Lao context.Harm reduction should be a core element of a public health response to HIV where drug use and IDU exists. Recommendations include the necessity of increasing the awareness of harm reduction among law enforcement officers and providing appropriate evidence to support the needs of harm reduction policy and programs. HIV prevention and treatment strategies should be integrated within existing social and cultural frameworks, working with the task force for HIV/IDU and other government counterparts.

Laos case study.

Peuan Mit is a Lao organization working to address the needs of children and youth living and working on the streets. This case study outlines how a trusted and strong relationship with local police provides mutual benefit.