Plaidoyer pour l'accès équitable aux nouvelles technologies de santé : le cas du Kymriah®.

INTRODUCTION: Patents have been thought of as an incentive model for research, conferring temporary monopolies to take advantage of an invention. In the pharmaceutical market, unmerited patents are granted, allowing firms to benefit from illegitimate monopolies and demand high prices. These abuses are at the expense of access to care and the financial sustainability of health care systems.These abuses have been demonstrated on treatments for HIV and hepatitis, and are also practiced on anti-cancer treatments such as CAR-T therapies (Chimeric Antigen Receptor T-Cell), whose particularly high prices are a challenge for health systems. PURPOSE OF RESEARCH: Médecins du Monde and Public Eye, two NGOs advocating on price and access to treatment, wanted to question the patentability of CAR-T treatments as well as to strengthen the capacity of health systems to negotiate fairer prices. These organizations filed a patent opposition against one of these treatments, Kymriah® (tisagenlecleucel). RESULTS: Through this initiative, these organizations alerted public opinion and policy makers on the high prices of CAR-T treatments. The opposition forced Novartis and the University of Pennsylvania to request the revocation of the patent. This action suggests that the patent was granted when it failed to meet the patentability criteria. CONCLUSIONS: The treatment is still covered by other patents, this opposition does not end the monopoly. Nevertheless, it weakens the intellectual property on this drug and strengthens the States during price negotiations.

[Advocating for equitable access to new health technologies: The case of Kymriah®]. / Plaidoyer pour l'accès équitable aux nouvelles technologies de santé : le cas du Kymriah®.

INTRODUCTION: Patents have been thought of as an incentive model for research, conferring temporary monopolies to take advantage of an invention. In the pharmaceutical market, unmerited patents are granted, allowing firms to benefit from illegitimate monopolies and demand high prices. These abuses are at the expense of access to care and the financial sustainability of health care systems.These abuses have been demonstrated on treatments for HIV and hepatitis, and are also practiced on anti-cancer treatments such as CAR-T therapies (Chimeric Antigen Receptor T-Cell), whose particularly high prices are a challenge for health systems.Purpose of research: Médecins du Monde and Public Eye, two NGOs advocating on price and access to treatment, wanted to question the patentability of CAR-T treatments as well as to strengthen the capacity of health systems to negotiate fairer prices. These organizations filed a patent opposition against one of these treatments, Kymriah® (tisagenlecleucel). RESULTS: Through this initiative, these organizations alerted public opinion and policy makers on the high prices of CAR-T treatments. The opposition forced Novartis and the University of Pennsylvania to request the revocation of the patent. This action suggests that the patent was granted when it failed to meet the patentability criteria. CONCLUSIONS: The treatment is still covered by other patents, this opposition does not end the monopoly. Nevertheless, it weakens the intellectual property on this drug and strengthens the States during price negotiations.

Insufficient access to harm reduction measures in prisons in 5 countries (PRIDE Europe): a shared European public health concern.

BACKGROUND: Prisoners constitute a high-risk population, particularly for infectious diseases. The aim of this study was to estimate the level of infectious risk in the prisons of five different European countries by measuring to what extent the prison system adheres to WHO/UNODC recommendations. METHODS: Following the methodology used in a previous French survey, a postal/electronic questionnaire was sent to all prisons in Austria, Belgium, Denmark and Italy to collect data on the availability of several recommended HIV-HCV prevention interventions and HBV vaccination for prisoners. A score was built to compare adherence to WHO/UNODC recommendations (considered a proxy of environmental infectious risk) in those 4 countries. It ranged from 0 (no adherence) to 12 (full adherence). A second score (0 to 9) was built to include data from a previous French survey, thereby creating a 5-country comparison. RESULTS: A majority of prisons answered in Austria (100 %), France (66 %) and Denmark (58 %), half in Belgium (50 %) and few in Italy (17 %), representing 100, 74, 89, 47 and 23 % coverage of the prison populations, respectively. Availability of prevention measures was low, with median adherence scores ranging from 3.5 to 4.5 at the national level. These results were confirmed when using the second score which included France in the inter-country comparison. Overall, the adherence score was inversely associated with prison overpopulation rates (p = 0.08). CONCLUSIONS: Using a score of adherence to WHO/UNODC recommendations, the estimated environmental infectious risk remains extremely high in the prisons of the 5 European countries assessed. Public health strategies should be adjusted to comply with the principle of equivalence of care and prevention with the general community.

Limited access to HIV prevention in French prisons (ANRS PRI2DE): implications for public health and drug policy.

BACKGROUND: Overpopulation, poor hygiene and disease prevention conditions in prisons are major structural determinants of increased infectious risk within prison settings but evidence-based national and WHO guidelines provide clear indications on how to reduce this risk. We sought to estimate the level of infectious risk by measuring how French prisons adhere to national and WHO guidelines. METHODS: A nationwide survey targeting the heads of medical (all French prisons) and psychiatric (26 French prisons) units was conducted using a postal questionnaire and a phone interview mainly focusing on access to prevention interventions, i.e. bleach, opioid substitution treatment (OST), HBV vaccination and post-exposure prophylaxis (PEP) for French prisoners. Two scores were built reflecting adherence to national and WHO international guidelines, ranging from 0 (no adherence) to 10 (maximum adherence) and 0 to 9 respectively. RESULTS: A majority (N=113 (66%)) of the 171 prisons answered the questionnaires, representing 74% coverage (46,786 prisoners) of the French prison population: 108 were medical units and 12 were psychiatric units. Inmate access to prevention was poor. The median[IQR] score measuring adherence to national guidelines was quite low (4.5[2.5; 5.5]) but adherence to WHO guidelines was even lower 2.5[1.5; 3.5]; PEP was absent despite reported risky practices. Unsuitable OST delivery practices were frequently observed. CONCLUSIONS: A wide gap exists between HIV prevention policies and their application in prisons. Similar assessments in other countries may be needed to guide a global policy reform in prison settings. Adequate funding together with innovative interventions able to remove structural and ideological barriers to HIV prevention are now needed to motivate those in charge of prison health, to improve their working environment and to relieve French prisoners from their currently debilitating conditions.

Illicit drug use and injection practices among drug users on methadone and buprenorphine maintenance treatment in France.

AIMS: To evaluate the associations between methadone and high-dose buprenorphine maintenance treatment and illicit drug use and injection among drug users in France. DESIGN: A cross-sectional study. Data were gathered using a questionnaire administered containing closed-ended questions. SETTING: Drug dependence clinics (DDC) and general practitioners' (GPs) offices in three French cities. PARTICIPANTS: Drug users undergoing maintenance treatment with methadone (n = 197) and buprenorphine (n = 142). MEASUREMENTS: Interviews covered the use of illicit drugs (heroin, cocaine or crack) and injection practices (illicit drugs and/or substitution drugs) during the last month, current treatment modalities, socio-demographic and health characteristics. Bivariate analysis and multivariate logistic regressions were conducted. FINDINGS: Overall, 35.4% of respondents (34.5% in the methadone group, 36.6% in the buprenorphine group, P= 0.69) had used at least one illicit drug, 25.7% reported having injected drugs and 15.3% had injected the substitution drug. Injection was more common among buprenorphine-maintained individuals (40.1%) than among users on methadone (15.2%) (P < 0.01). Multivariate analyses indicate that the type of substitution drug (buprenorphine versus methadone) was not associated with illicit drug use (OR = 1.1; 95% CI = 0.7-1.8). In the buprenorphine group, injection was related independently to social situation, as measured by housing (unstable versus stable housing, OR = 4.3; 95% CI = 1.6-11.5), but this was not the case in the methadone group. The risk of injection increased with buprenorphine dosage (high/low dosage OR = 6.2; 95% CI = 2.0-19.7), but this association was not observed in the methadone group. CONCLUSION: Further studies comparing the benefits of these two types of treatment should be carried out, taking outcomes such as physical health, mental health and social functioning into consideration.

Implementing harm reduction for heroin users in Afghanistan, the worldwide opium supplier.

Afghanistan has suffered decades of war, occupation and unrest. It is also the world's greatest producer of opium and drug production and trafficking account for a third of the total Afghan economy. Currently alongside the "War on Terrorism", the control and eradication of opium production and related trafficking is a main concern of the international community. However, this focus on supply reduction has meant scant attention has been paid to increasing drug use problems within the country; it is estimated there are up to 25,000 opium users and 20,000 heroin users in Kabul city. Drug use is often a response to war, poverty and under-development, however, street opium and heroin manufactured in the country are widely available, affordable and of high purity. This paper documents the efforts of non-governmental organisations to promote and develop harm reduction and treatment services for problem drug users in Afghanistan in this difficult context.