• Supplementary protection certificates and their impact on access to medicines in Europe: case studies of sofosbuvir, trastuzumab and imatinib

      Hu, Y; Eynikel, D; Boulet, P; Krikorian, G (BioMed Central, 2020-01-14)
      In recent years, there has been increasing pressure on public health systems in high-income countries due to high medicines prices, one of the underlying causes of which are the market monopolies granted to pharmaceutical undertakings. These monopolies have been facilitated by expanded forms of intellectual property protections, including the extension of the exclusivity period after the expiration of the patent term concerning medicinal products. In the European Union such an approach lies in the Supplementary Protection Certificate, a mechanism formally introduced under Regulation 1768/92/EEC (now: Regulation 469/2009/EC, amended). After more than 20 years of implementation since it was first introduced, the common justifications for SPCs are being challenged by recent findings as to their functioning and impact. Similarly, legitimate questions have been voiced as to the negative impact of SPCs on timely access to affordable medicines. On the basis of an analysis of three medicines for hepatitis C and cancer treatments, the present article critically engages with the policy justifications underlying SPCs. It then analyses access challenges to a hepatitis C medicine and an HIV treatment in Europe, highlighting the social cost of the introduction of SPCs. Both the normative and empirical analyses have demonstrated that the common justifications supporting the SPC regime are deeply questionable. The addition of SPC exclusivity has also heavily delayed competition and maintained high medicines prices in European countries. Ultimately, the granting of such extended exclusive private rights on medicines may result in unnecessary suffering and be a factor in the erosion of access to medicines for all.
    • Survivors' Perceptions of Public Health Messages During an Ebola Crisis in Liberia and Sierra Leone: An Exploratory Study

      Schwerdtle, P; De Clerck, V; Plummer, V (Wiley-Blackwell, 2017-09-20)
      The outbreak of Ebola virus disease in Guinea, Liberia, and Sierra Leone was the largest epidemic of Ebola ever recorded. The healthcare workforce was diminished and exhausted as the region emerged from civil war. Few qualitative, descriptive studies have been conducted to date that concentrate on the voices of Ebola survivors and their perceptions of health messages. In this study, we employed an interpretive, qualitative design to explore participant experiences. Twenty five survivors who had recovered from Ebola were recruited from three villages in Liberia and Sierra Leone in August 2015. Data were collected using semistructured interviews. Data analysis revealed four themes: (i) degrees of mistrust; (ii) messages conflicting with life and culture; (iii) seeing is believing; and (iv) recovery inspires hope. The findings were explored in the context of the relevant literature. The themes highlight the need to develop culturally-appropriate messages, underpinned by a sound understanding of the community and a willingness to work with the culture and trusted leaders.
    • Sustaining Access to Antiretroviral Therapy in the Less-Developed World: Lessons from Brazil and Thailand.

      Ford, N; Wilson, D; Costa Chaves, G; Lotrowska, M; Kijtiwatchakul, K; Médecins Sans Frontières, 522 Mooban Nakorn Thai 14, Ladphrao Soi 101/1, Bangkok 10240, Thailand. nathan.ford@london.msf.org (2007-07)
      ANTIRETROVIRAL ROLLOUT IN BRAZIL AND THAILAND: Brazil and Thailand are among few developing countries to achieve universal access to antiretroviral therapy. Three factors were critical to this success: legislation for free access to treatment; public sector capacity to manufacture medicines; and strong civil society action to support government initiatives to improve access. LOCAL PRODUCTION OF AFFORDABLE, NON-PATENTED DRUGS: Many older antiretroviral drugs are not patented in either country and affordable generic versions are manufactured by local pharmaceutical institutes. EFFORTS TO ENSURE ACCESS TO EXPENSIVE, PATENTED DRUGS: Developing countries were not required to grant patents on medicines until 2005, but under US government threats of trade sanctions, Thailand and Brazil began doing so at least ten years prior to this date. Brazil has used price negotiations with multi-national pharmaceutical companies to lower the price of newer patented antiretrovirals. However, the prices obtained by this approach remain unaffordable. Thailand recently employed compulsory licensing for two antiretrovirals, obtaining substantial price reductions, both for generic and brand products. Following Thailand's example, Brazil has issued its first compulsory license. LESSONS LEARNED: Middle-income countries are unable to pay the high prices of multinational pharmaceutical companies. By relying on negotiations with companies, Brazil pays up to four times more for some drugs compared with prices available internationally. Compulsory licensing has brought treatment with newer antiretrovirals within reach in Thailand, but has resulted in pressure from industry and the US government. An informed and engaged civil society is essential to support governments in putting health before trade.
    • A systematic review of task- shifting for HIV treatment and care in Africa.

      Callaghan, Mike; Ford, Nathan; Schneider, Helen; Department of Anthropology, University of Toronto, Canada. mike.callaghan@utoronto.ca. (2010-08)
      BACKGROUND: Shortages of human resources for health (HRH) have severely hampered the rollout of antiretroviral therapy (ART) in sub-Saharan Africa. Current rollout models are hospital- and physician-intensive. Task shifting, or delegating tasks performed by physicians to staff with lower-level qualifications, is considered a means of expanding rollout in resource-poor or HRH-limited settings. METHODS: We conducted a systematic literature review. Medline, the Cochrane library, the Social Science Citation Index, and the South African National Health Research Database were searched with the following terms: task shift*, balance of care, non-physician clinicians, substitute health care worker, community care givers, primary healthcare teams, cadres, and nurs* HIV. We mined bibliographies and corresponded with authors for further results. Grey literature was searched online, and conference proceedings searched for abstracts. RESULTS: We found 2960 articles, of which 84 were included in the core review. 51 reported outcomes, including research from 10 countries in sub-Saharan Africa. The most common intervention studied was the delegation of tasks (especially initiating and monitoring HAART) from doctors to nurses and other non-physician clinicians. Five studies showed increased access to HAART through expanded clinical capacity; two concluded task shifting is cost effective; 9 showed staff equal or better quality of care; studies on non-physician clinician agreement with physician decisions was mixed, with the majority showing good agreement. CONCLUSIONS: Task shifting is an effective strategy for addressing shortages of HRH in HIV treatment and care. Task shifting offers high-quality, cost-effective care to more patients than a physician-centered model. The main challenges to implementation include adequate and sustainable training, support and pay for staff in new roles, the integration of new members into healthcare teams, and the compliance of regulatory bodies. Task shifting should be considered for careful implementation where HRH shortages threaten rollout programmes.
    • Task shifting for antiretroviral treatment delivery in sub-Saharan Africa: not a panacea.

      Philips, M; Zachariah, R; Venis, S; Analysis and Advocacy Unit, Médecins Sans Frontières, Brussels Operational Centre, Belgium. (Elsevier, 2008-02-23)
    • Teleradiology usage and user satisfaction with the telemedicine system operated by Médecins Sans Frontières

      Halton, Jarred; Kosack, Cara; Spijker, Saskia; Joekes, Elizabeth; Andronikou, Savvas; Chetcuti, Karen; Brant, William E; Bonnardot, Laurent; Wootton, Richard (Frontiers Media, 2014-10-28)
      Médecins Sans Frontières (MSF) began a pilot trial of store-and-forward telemedicine in 2010, initially operating separate networks in English, French, and Spanish; these were merged into a single, multilingual platform in 2013. We reviewed the pattern of teleradiology usage on the MSF telemedicine platform in the 4-year period from April 2010. In total, 564 teleradiology cases were submitted from 22 different countries. A total of 1114 files were uploaded with the 564 cases, the majority being of type JPEG (n = 1081, 97%). The median file size was 938 kb (interquartile range, IQR 163-1659). A panel of 14 radiologists was available to report cases, but most (90%) were reported by only 4 radiologists. The median radiologist response time was 6.1 h (IQR 3.0-20). A user satisfaction survey was sent to 29 users in the last 6 months of the study. There was a 28% response rate. Most respondents found the radiologist's advice helpful and all of them stated that the advice assisted in clarification of a diagnosis. Although some MSF sites made substantial use of the system for teleradiology, there is considerable potential for expansion. More promotion of telemedicine may be needed at different levels of the organization to increase engagement of staff.
    • Ten Tips to Improve the Visibility and Dissemination of Research for Policy Makers and Practitioners

      Tripathy, J; Bhatnagar, A; Shewade, H; Kumar, A; Zachariah, R; Harries, A (International Union Against Tuberculosis and Lung Disease, 2017-03-21)
      Effective dissemination of evidence is important in bridging the gap between research and policy. In this paper, we list 10 approaches for improving the visibility of research findings, which in turn will hopefully contribute towards changes in policy. Current approaches include using social media (Facebook, Twitter, LinkedIn); sharing podcasts and other research outputs such as conference papers, posters, presentations, reports, protocols, preprint copy and research data (figshare, Zenodo, Slideshare, Scribd); and using personal blogs and unique author identifiers (ORCID, ResearcherID). Researchers and funders could consider drawing up a systematic plan for dissemination of research during the stage of protocol development.
    • Time to embrace access programmes for medicines: Lessons from the South African flucytosine access programme

      Shroufi, A; Govender, NP; Meintjes, G; Black, J; Nel, J; Moosa, MY; Menezes, C; Dawood, H; Wilson, D; Trivino Duran, L; et al. (Elsevier, 2020-02-29)
      BACKGROUND: Cryptococcal Meningitis (CM) is estimated to cause 181,000 deaths annually; with the majority occurring in Sub Saharan Africa. Flucytosine is recommended by the World Health Organization as part of the treatment for CM. Widespread use of flucytosine could reduce mortality in hospital by as much as 40% compared to the standard of care, yet due to market failure quality assured flucytosine remains unregistered and largely inaccessible throughout Africa. METHODS: The recently established South African flucytosine clinical access programme is an attempt to address market failure which led to a lack of public-sector access to flucytosine for cryptococcal meningitis, by making the medicine freely available to tertiary hospitals in South Africa. RESULTS: Between November 2018 and September 2019, 327 CM patients received flucytosine through this programme, with efforts to support sustainable national scale up presently ongoing. We describe why this programme was needed, its catalytic potential, what is still required to ensure widespread access to flucytosine, and observation from this experience that may have wider relevance. CONCLUSIONS: The South African Flucytosine Access Programme illustrates how access programmes may be one part of the solution to addressing the vicious cycle of perceived low demand, limiting manufacturer interest in specific product markets.
    • Tough choices: tenofovir, tenders and treatment

      Ford, N; Gray, A; Venter, F (South African Medical Association, 2008-06-04)
      Scaling up antiretroviral therapy (ART) in developing countries would not have been possible without market competition, which has driven down the price of standard first-line ARV drugs from more than US$12,000 per person per year in 2000 to US$99 today. However, access to new, second-line ARVs remains largely restricted to originator (patented) drugs. This causes significant challenges in countries where access to newer drugs is becoming inceasingly important as programmes mature and face challenges related to drug toxicity and resistance. Toxicity, in particular, has emerged as a major reason for individual drug switches and regimen changes, and is strongly implicated in decreasing adherence.
    • Trade concerns must not be allowed to set the public health agenda.

      Ford, N; 't Hoen, E; McKee, M (Elsevier, 2003-01-04)
    • Trade systems in less-developed countries.

      Kamal, M; 't Hoen, E (Elsevier, 2001-05-19)
    • Treating HIV in the developing world: getting ahead of the drug development curve.

      Ford, N; Calmy, A; von Schoen-Angerer, T (Elsevier, 2007-01)
    • TRIPs revisited.

      Ford, N (2001-11)
    • TRIPS, pharmaceutical patents, and access to essential medicines: a long way from Seattle to Doha.

      't Hoen, E; Globalisation Project of Medecins sans Frontieres ("MSF") Access to Essential Medicines Campaign. (Chicago Journal of International Law, 2002)
    • Understanding health care in the south Caucasus: examples from Armenia.

      von Schoen-Angerer, T; Médecins Sans Frontières, Manushyan St 48, 375012 Yerevan, Armenia. tavschoen@yahoo.com (2004-09-04)
    • Universal health coverage in a regional Nepali hospital: who is exempted from payment? [Short communication]

      Basnet, R.; Shrestha, B. R.; Nagaraja, S. B.; Basnet, B.; Satyanarayana, S.; Zachariah, R.; Nepal Health Sector Support Programme, Mid-Western Regional Health Directorate, Surkhet, Nepal (International Union Against Tuberculosis and Lung Disease, 2013-03-21)
      This study assessed the characteristics of beneficiaries of a government-led policy of exemption for payment being provided in a regional hospital in Nepal. In January and February 2012, 9547 patients sought services at the out-patient clinic, the majority (83%) of whom were from the same district although this was a referral hospital for 15 districts. Only 10.8% received exemption from payment; 66% of the individuals aged >60 years and eligible for exemption were missed. These shortcomings highlight intrinsic weaknesses in the current implementing mechanisms for payment exemption, which may not be providing financial protection. This hampers efforts towards achieving universal health coverage.