Beyond price: the effects of non-financial barriers on access to drugs and health outcomes.

OBJECTIVES: We study the impact of the pharmacy dispensing channel (as a proxy for access to drugs) on the drug purchases, health outcomes, and health care utilization (emergency room visits or hospitalizations) of chronically ill patients in Liguria, Italy, in 2017. METHODS: We use the coarsened exact matching algorithm to compare the health outcomes for a treated group of patients living in a local health authority (LHA) where drug distribution through community pharmacies was restricted. These patients were matched to a control group of patients living in other LHAs, where drugs were also dispensed through a broad network of community pharmacies. We exploit a unique administrative dataset with information on the socio-demographic characteristics and health care services utilization of Ligurian patients with chronic cardiovascular and respiratory ailments. We restrict our analysis to patients 65 years of age or older who were admitted to hospitals from 2013 to 2016 with either a principal or secondary diagnosis connected to chronic cardiovascular and respiratory diseases. RESULTS: Reduced access to drugs leads to lowered drug consumption, a higher probability of adverse health outcomes including mortality, and a higher consumption of medical services in terms of hospitalizations and emergency room visits. These effects increase with patients' age. CONCLUSION: The pharmacy dispensing channel significantly affects drug consumption and acts as a proxy for adherence among chronically ill patients. Thus, health outcomes and health care utilization should be carefully evaluated when comparing the costs of alternative dispensing channels.

Improving access to the treatment of hepatitis C in low- and middle-income countries: evaluation of a patient assistance programme.

Background Modern antiviral treatments have high cure rates against the hepatitis C virus however, the high cost associated with branded medicines and diagnostic tests, have resulted in poor access for many low-income patients residing in low-and-middle-income countries. Objective This study aimed to evaluate the role of a patient assistance programme and generic medicines in improving access to treatment of low-income hepatitis C patients in a low-and-middle-income country. Setting A major teaching public hospital in Islamabad, Pakistan. Methods Hepatitis C patients who presented and enrolled for the patient assistance programme during 12 months (1st July 2015 and 30th June 2016) were included. Demography, prescription characteristics, the total costs of Hepatitis C treatment, medicine cost supported by the programme, out-of-pocket cost borne by the patient and average cost effectiveness ratio per sustained virologic response were calculated and compared for different generic and branded regimens. Main outcome measure cost contribution of patient assistance programme. Results A total of 349 patients initiated the treatment through the programme and of those 334 (95.7%) completed the prescribed treatment. There were 294 (88.02%) patients who achieved sustained virologic response. Patient assistance programme contributed medicines cost averaging 60.28-86.26% of the total cost of treatment ($1634.6) per patient. The mean (SE) cost per patient for generic option (Sofosbuvir/Ribavirin) was the lowest [$658.36 (22.3) per patient, average cost effectiveness ratio = $720.1/SVR] than branded option (Sovaldi/Ribavirin) [$2218.66 (37.6) per patient, average cost effectiveness ratio = $2361.8/SVR] of the three available treatment regimens. From patients' perspectives, the mean (SE) out-of-pocket cost was $296.9 (6.7) which primarily included diagnostic cost (69.9%) of the total cost. Conclusions Patient assistance programme, combined with generic brands of newer hepatitis C treatment offered a significant reduction in cost and widens access to hepatitis C treatment in low-and middle-income countries. However, substantial out-of-pocket costs of the treatment presents an important barrier for service access. There is a scope to widen such financial assistance programme to offer other costs attributed to patients, specifically for diagnosis, to widen service use in low-and-middle-income countries.

El acceso a los medicamentos: conflictos entre derechos de propiedad intelectual y protección de la salud pública / O acesso aos medicamentos: conflitos entre direitos de propriedade intelectual e proteção da saúde pública / The access to drugs: conflicts between intellectual property and public health protection

Entre los mayores obstáculos que enfrenta en todo el mundo el acceso a los medicamentos se encuentran las cuestiones relativas a los derechos de propiedad intelectual y la falta de competencia, unido al retardo y postergación en la generación de investigación y desarrollo (I+D) sobre aquellas enfermedades que afectan de manera importante a la población de países en desarrollo y países menos adelantados. En este trabajo se analiza el fortalecimiento de la patente farmacéutica contemplada en el Acuerdo sobre los Aspectos de los Derechos de Propiedad Intelectual (ADPIC) de la Organización Mundial de Comercio (OMC) y el actual régimen de incentivo imperante para medicamentos nuevos, sus consecuencias y actuales conflictos. En ellos suelen enfrentarse los intereses de países desarrollados, presionados por una poderosa industria farmacéutica, con los intereses de países en desarrollo y países menos adelantados.

Topics related to intellectual property rights and lack of competency are found among the major obstacles facing the access to drugs in the world, together with the delay and postponement in the generation of R+D about those diseases affecting disproportionately to the population of developing countries and least developed countries. In this study, the strengthening of pharmaceutical patents included in the Agreement on trade-related aspects of intellectual property rights of the World Trade Organization (WTO) and the current prevailing incentive towards new drugs, their consequences and current conflicts are analyzed. In these, generally, the developed countries interests are confronted -pressed by a powerful pharmaceutical industry- with the interests of developing countries and least developed countries.

Entre os maiores obstáculos que enfrenta em todo o mundo, o acesso aos medicamentos se encontram as questões relativas aos direitos de propriedade intelectual e a falta de competência, aliado ao retardo e postergação na geração de I+D sobre aquelas enfermidades que afetam de maneira desproporcionada a população dos países em desenvolvimento e países menos adiantados. Neste trabalho se analisa o fortalecimento da patente farmacêutica contemplada no Acordo sobre os Aspectos dos Direitos de Propriedade Intelectual (ADPIC) da Organização Mundial de Comércio (OMC) e o atual regime de incentivo imperante para medicamentos novos, suas consequências e atuais conflitos. Neles devem ser enfrentados os interesses de países desenvolvidos -pressionados por uma poderosa indústria farmacêutica- com os interesses de países em desenvolvimento e países menos adiantados.

Medicamentos esenciales y Acuerdo sobre los ADPIC: colisión entre el derecho a la salud y el derecho de propiedad intelectual / Essential medicines and the TRIPS Agreement: collision between the right to health and intellectual property rights

El fortalecimiento mundial de la patente farmacéutica tensiona el acceso a los medicamentos esenciales. De acuerdo a este trabajo ello ha derivado en la colisión del derecho de propiedad intelectual que impulsa el Acuerdo sobre los Aspectos de los Derechos de Propiedad Intelectual relacionados con el Comercio (ADPIC) de la Organización Mundial del Comercio (OMC), con el derecho a la salud previsto en el Pacto Internacional de Derechos Económicos, Sociales y Culturales (PIDESC). Diversas controversias ventiladas en la OMC ilustran el enfrentamiento entre países con una poderosa industria farmacéutica y los intereses de países en desarrollo. Se concluye que las normas ADPIC-plus suscritas en tratados de libre comercio por países en desarrollo, que confieren al titular de la patente farmacéutica más derechos que los previstos en el propio Acuerdo sobre los ADPIC, son incompatibles con las obligaciones que asumen respecto del acceso a medicamentos esenciales en el marco del derecho a la salud del PIDESC.(AU)

The strengthening of pharmaceutical patent protection globally puts strains on access to essential medicines. According to the present paper, this process has led to the collision of the intellectual property rights adopted in the World Trade Organization (WTO) Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement and the right to health stated in the International Covenant on Economic, Social and Cultural Rights (ICESCR). Several controversies disputed in the WTO illustrate the confrontation between countries with a powerful pharmaceutical industry and the interests of developing countries. It is concluded that the TRIPS-plus rules subscribed to by developing countries in free trade agreements which give the pharmaceutical patent holder more rights than those stipulated in the original TRIPS Agreement are incompatible with the obligations to provide access to essential medicines under the right to health of the ICESCR.(AU)

Alternativas al modelo de investigación y desarrollo de medicamentos / Alternatives to the drug research and development model

Un tercio de la población mundial carece de acceso a los medicamentos y la situación es peor en los países pobres, en los que hasta un 50% de la población carece de acceso. El fracaso de los sistemas actuales de incentivos, basados en la propiedad intelectual, para ofrecer los productos farmacéuticos necesarios, especialmente en los países del sur, llama a la acción. Los problemas relacionados con el acceso a medicamentos no pueden ser resueltos tan solo a través de mejoras o adaptaciones de los modelos de incentivos existentes. El modelo del sistema de propiedad intelectual no ofrece la innovación necesaria para los países en desarrollo, se necesitan nuevos mecanismos que de forma simultánea y eficaz promuevan la innovación y el acceso a los medicamentos. Un tratado internacional vinculante sobre investigación y desarrollo, que se negocie bajo los auspicios de la Organización Mundial de la Salud, puede proporcionar el marco adecuado para garantizar el establecimiento de prioridades, la coordinación y la financiación sostenible de los medicamentos a precios asequibles para los países en desarrollo.(AU)

One-third of the global population lacks access to medications; the situation is worse in poor countries, where up to 50% of the population lacks access. The failure of current incentive systems based in intellectual property to offer the necessary pharmaceutical products, especially in the global south, is a call to action. Problems related to drug access cannot be solved solely through improvements or modifications in the existing incentive models. The intellectual property system model does not offer sufficient innovation for developing countries; new mechanisms that effectively promote innovation and drug access simultaneously are needed. A binding international agreement on research and development, negotiated under the auspices of the World Health Organization, could provide an adequate framework for guaranteeing priority-setting, coordination, and sustainable financing of drugs at reasonable prices for developing countries.(AU)

Medicamentos esenciales y Acuerdo sobre los ADPIC: colisión entre el derecho a la salud y el derecho de propiedad intelectual / Essential medicines and the TRIPS Agreement: collision between the right to health and intellectual property rights

El fortalecimiento mundial de la patente farmacéutica tensiona el acceso a los medicamentos esenciales. De acuerdo a este trabajo ello ha derivado en la colisión del derecho de propiedad intelectual que impulsa el Acuerdo sobre los Aspectos de los Derechos de Propiedad Intelectual relacionados con el Comercio (ADPIC) de la Organización Mundial del Comercio (OMC), con el derecho a la salud previsto en el Pacto Internacional de Derechos Económicos, Sociales y Culturales (PIDESC). Diversas controversias ventiladas en la OMC ilustran el enfrentamiento entre países con una poderosa industria farmacéutica y los intereses de países en desarrollo. Se concluye que las normas ADPIC-plus suscritas en tratados de libre comercio por países en desarrollo, que confieren al titular de la patente farmacéutica más derechos que los previstos en el propio Acuerdo sobre los ADPIC, son incompatibles con las obligaciones que asumen respecto del acceso a medicamentos esenciales en el marco del derecho a la salud del PIDESC.

The strengthening of pharmaceutical patent protection globally puts strains on access to essential medicines. According to the present paper, this process has led to the collision of the intellectual property rights adopted in the World Trade Organization (WTO) Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement and the right to health stated in the International Covenant on Economic, Social and Cultural Rights (ICESCR). Several controversies disputed in the WTO illustrate the confrontation between countries with a powerful pharmaceutical industry and the interests of developing countries. It is concluded that the TRIPS-plus rules subscribed to by developing countries in free trade agreements which give the pharmaceutical patent holder more rights than those stipulated in the original TRIPS Agreement are incompatible with the obligations to provide access to essential medicines under the right to health of the ICESCR.

Alternativas al modelo de investigación y desarrollo de medicamentos / Alternatives to the drug research and development model

Un tercio de la población mundial carece de acceso a los medicamentos y la situación es peor en los países pobres, en los que hasta un 50% de la población carece de acceso. El fracaso de los sistemas actuales de incentivos, basados en la propiedad intelectual, para ofrecer los productos farmacéuticos necesarios, especialmente en los países del sur, llama a la acción. Los problemas relacionados con el acceso a medicamentos no pueden ser resueltos tan solo a través de mejoras o adaptaciones de los modelos de incentivos existentes. El modelo del sistema de propiedad intelectual no ofrece la innovación necesaria para los países en desarrollo, se necesitan nuevos mecanismos que de forma simultánea y eficaz promuevan la innovación y el acceso a los medicamentos. Un tratado internacional vinculante sobre investigación y desarrollo, que se negocie bajo los auspicios de la Organización Mundial de la Salud, puede proporcionar el marco adecuado para garantizar el establecimiento de prioridades, la coordinación y la financiación sostenible de los medicamentos a precios asequibles para los países en desarrollo.

One-third of the global population lacks access to medications; the situation is worse in poor countries, where up to 50% of the population lacks access. The failure of current incentive systems based in intellectual property to offer the necessary pharmaceutical products, especially in the global south, is a call to action. Problems related to drug access cannot be solved solely through improvements or modifications in the existing incentive models. The intellectual property system model does not offer sufficient innovation for developing countries; new mechanisms that effectively promote innovation and drug access simultaneously are needed. A binding international agreement on research and development, negotiated under the auspices of the World Health Organization, could provide an adequate framework for guaranteeing priority-setting, coordination, and sustainable financing of drugs at reasonable prices for developing countries.

And now for something completely different: drugs that work!-The patients' perspective.

The result of drug development so far is beyond expectations and also beyond what is possible. The reason for this is probably that the aim is not a better quality of life for the patient and her loved ones but profit. Working together with patients on an equal basis-and in the patients' best interest-will bring better drugs to the market that work and provide better quality of life and with less severe side effects. For the pharmaceutical companies that want to benefit patients, it will bring enough profit. Essential is that we are honest about our interests and respect the interest of one another. And go for the win-win situation instead of the compromise. We can also do better by doing research on combinations of new and existing drugs. This might be faster available for patients and also cheaper. The government can help by making the rules for drug development easier on safety. The cooperation with patients will still make things safe enough. The government has to support the patient advocacy groups financially to make them less dependent on the pharmaceutical companies. And finally, the patient advocacy groups can do a lot to make the patients, doctors, researchers, government and industry more cancer literate.

O patenteamento de polimorfos na indústria farmacêutica e o acesso a medicamentos / The patenting of polymorphs in the pharmaceutical industry and access to medicines

Recentemente, as discussões sobre o patenteamento na área farmacêutica e seu impacto sobre o acesso da população aos medicamentos tem se intensificado, e, em 2008, o GIPI decidiu que patentes incrementais não deveriam ser concedidas no Brasil. Assim, neste trabalho, são discutidos os possíveis impactos dessas patentes para o acesso aos medicamentos, por meio do estudo do caso dos polimorfos. Como contribuição, a importância do patenteamento de polimorfos nas várias áreas tecnológicas foi estimada a partir dos depósitos no Brasil. Foi observado que mais de 70 por cento dos depósitos são da área farmacêutica. Estudos de casos foram feitos com dois fármacos: paroxetina e atorvastatina. A detentora do medicamento referência depositou cerca de metade dos pedidos para polimorfos da paroxetina. No caso da atorvastatina, embora a detentora do registro não seja o maior depositante, é ela quem reivindica o maior percentual de polimorfos. O estudo constatou que a indústria farmacêutica tem usado agressivamente as patentes como estratégia econômica, confirmando a preocupação do setor saúde sobre o acesso aos medicamentos.

Recently, discussions on patenting in the pharmaceutical area and its impact on people's access to drugs have intensified, and in 2008 the GIPI decided that the incremental patents should not be granted in Brazil. So this paper discusses the possible impacts of these patents on access to medicines through the case study of the polymorphs. As a contribution, the importance of patenting of polymorphs in various technology areas was estimated from the deposits in Brazil. It was observed that more than 70 percent of deposits are in the pharmaceutical area. Case studies were made with two drugs: atorvastatin and paroxetine. The holder of the reference drug deposited about half of the requests for polymorphs of paroxetine. In the case of atorvastatin, although the holder of the registration is not the largest depositor, who claims it is the highest percentage of polymorphs. The study found that the pharmaceutical industry has aggressively used patents as economic strategy, confirming the concern of the health sector on access to medicines.