Access to essential medicines for sexual and reproductive health care: the role of the pharmaceutical industry and international regulation

Abstract

The range of medicines and technologies that are essential for sexual and reproductive health care is well established, but access to them is far from universally assured, particularly in less developed countries. This paper shows how the pharmaceutical industry plays a major role in the lack of access to essential medicines for sexual and reproductive health care, by a) investing in products for profit-making reasons despite their negative health impact (e.g. hormone replacement therapy), b) marketing new essential medicines at prices beyond the reach of countries that most need them (e.g. HPV vaccines), and c) failing to invest in the development of new products (e.g. microbicides and medical abortion pills). Small companies, some of them non-profit-making, struggle to fill some of that demand (e.g. for female condoms). International patent protection contributes to high prices of medicines, and while international agreements such as compulsory licensing under TRIPS and the Medicines Patent Pool allow for mechanisms to enable poorer countries to get access to essential medicines, the obstacles created by “big pharma” are daunting. All these barriers have fostered a market in sub-standard medicines (e.g. fake medical abortion pills sold over the internet). An agenda driven by sexual and reproductive health needs, based on the right to health, must focus on universal access to essential medicines at prices developing countries can afford. We call for greater public investment in essential medicines, expanded production of affordable generic drugs, and the development of broad strategic plans, that include affordable medicines and technologies, for addressing identified public health problems, such as cervical cancer.

Résumé

La panoplie de technologies et de médicaments essentiels pour les soins de santé génésique est bien établie, mais on est loin de l'accès universel, en particulier dans les pays les moins avancés. Cet article montre comment l'industrie pharmaceutique joue un rôle majeur dans le manque d'accès aux médicaments essentiels pour les soins de santé génésique a) en investissant dans un but de rentabilité en faveur de produits,malgré leurs conséquences négatives sur la santé (par exemplele traitement de substitution hormonale), b) en commercialisant les nouveaux médicaments essentiels à des prix hors de portée des pays qui en ont le plus besoin (par exemple les vaccins contre le VPH) et c) en n'investissant pas pour le développement de nouveaux produits (par exemple les microbicides et les pilules d'avortement médicamenteux). Les petites compagnies, dont certaines sans but lucratif, luttent pour combler une partie de ces besoins (par exemple le préservatif féminin). La protection internationale des brevets contribue au prix élevé des médicaments et si des accords internationaux, comme la concession de licences obligatoires au titre des ADPIC et la Communauté de brevets pour les médicaments, offrent des mécanismes permettant aux pays les plus pauvres d'accéder aux médicaments essentiels, les obstacles créés par les grandes compagnies pharmaceutiques sont redoutables. Toutes ces limitations ont encouragé un marché de médicaments de mauvaise qualité (par exemple de fausses pilules d'avortement médicamenteux vendues sur Internet). Un programme guidé par les besoins de santé génésique et fondé sur le droit à la santé doit se centrer sur l'accès universel aux médicaments essentiels à un prix abordable pour les pays en développement. Nous demandons un investissement public accru pour les médicaments essentiels, une production élargie de médicaments génériques abordables et la mise au point de vastes plans stratégiques, notamment des médicaments et des technologies à bon prix, pour répondre aux problèmes de santé publique, comme le cancer du col de l'utérus.

Resumen

Aunque se ha establecido claramente la variedad de medicamentos y tecnologías que son esenciales para los servicios de salud sexual y reproductiva, el acceso a estos está lejos de ser garantizado universalmente, en particular en los países menos desarrollados. En este artículo se muestra cómo la industria farmacéutica contribuye a la falta de acceso a estos medicamentos a) al invertir en productos por razones comerciales a pesar de su impacto negativo en la salud (p. ej. terapia de reposición hormonal), b) al comercializar nuevos medicamentos esenciales a precios inasequibles para los países que más los necesitan (p. ej. vacunas contra el VPH) y c) al no invertir en la creación de nuevos productos (p. ej. microbicidas y tabletas de aborto con medicamentos). Las pequeñas empresas, algunas sin fines de lucro, luchan por satisfacer parte de la demanda (p. ej. de condones femeninos). La protección de patentes internacionales contribuye a los elevados precios de los medicamentos y, aunque los acuerdos internacionales como las licencias obligatorias bajo el acuerdo TRIPS y la Reserva de Patentes de Medicamentos permiten mecanismos que les facilitan a los países más pobres obtener acceso a los medicamentos esenciales, los obstáculos creados por las “grandes farmacéuticas” son desalentadores. Todas estas barreras han fomentado un mercado de medicamentos de calidad inferior (p. ej. la venta por Internet de falsas tabletas de aborto con medicamentos). La agenda impulsada por las necesidades de salud sexual y reproductiva, basada en el derecho a la salud, se debe centrar en el acceso universal a los medicamentos esenciales a precios asequibles para los países en desarrollo. Hacemos un llamado para una mayor inversión pública en los medicamentos esenciales, mayor producción de medicamentos genéricos asequibles y la formulación de planes estratégicos más amplios, que incluyan medicamentos y tecnologías asequibles, con el fin de tratar los problemas de salud pública identificados, como el cáncer cervical.

Key Words:

• essential medicines
• pharmaceutical industry
• reproductive and sexual health care
• hormone replacement therapy
• human papillomavirus and vaccination
• medical abortion pills
• female condoms
• microbicides

Acknowledgements

An earlier version of this paper was presented at the meeting Repoliticizing sexual and reproductive health and rights, Langkawi, Malaysia, 3–6 August 2010. We thank Kajal Bhardwaj, Jeffrey O'Malley and Gary Dowsett for valuable comments at that meeting and since.

Notes

* The components of a comprehensive family planning programme included by UNFPA in the ICPD costed population package are as follows: contraceptive commodities and service delivery; capacity-building for information, education and communication regarding family planning and population and development issues; national capacity-building through support for training; infrastructure development and upgrading of facilities; policy development and programme evaluation; management information systems; basic service statistics; and focused efforts to ensure good quality care. (At: <www.unfpa.org/webdav/site/global/shared/documents/publications/2006/resources_flows_2006.doc> p.7).

* Various hormonal contraceptives are included on the WHO Model List of Essential Medicines, including levonorgestrel for emergency contraception. However, the two medical abortion pills, mifepristone and misoprostol, which are most effective when taken together, were only approved for inclusion after several years' delay because of concerns that WHO might be seen as “promoting” abortion. Even now, the entry for these pills carries the rider “where permitted under national law and where culturally acceptable”, the only medicines on the entire list that carry such a disclaimer. Fortunately, the more specific “Essential Medicines for Reproductive Health”, published in 2006, includes a full description of mifepristone with misoprostol for medical abortion, with no such “rider”.⁸ Nonetheless, even though it has been available since 1988, mifepristone was approved in only 46 countries as of June 2010 (see <http://gynuity.org/resources/info/list-of-mifepristone-approval>). Hence, most women must still use misoprostol alone.

* The quadrivalent vaccine (that protects against the four HPV types) received US Food and Drug Administration (FDA) approval in June 2008, before the final safety evaluation trials were complete, and it was then mass-marketed on TV and in cinemas in the US through advertisements pitched to young girls. The manufacturer also lobbied state legislators to introduce mandatory vaccination in schools for girls from age 11.³⁹ It has also given extensive financial support to various professional medical associations to promote the vaccine, providing lecture kits, slides and various rewards for educators.⁴⁰

* E.g. the Treatment Action Campaign in South Africa, who work to hold government accountable for health care service delivery, cultivate community leadership on HIV and AIDS, campaign against official AIDS denialism, and challenge the world's leading pharmaceutical companies to make treatment more affordable (see <www.tac.org.za>).

* “Eligible” here may mean excluding middle-income countries. According to the 2011 Médecins Sans Frontières report, Untangling the Web of ARV Price Reductions, presented at the 6th International AIDS Society conference on HIV pathogenesis, treatment and prevention, Rome, 17–20 July 2011, a number of pharmaceutical companies will no longer be providing preferential pricing for AIDS drugs to middle-income countries like Brazil, China, India and Thailand. At: <http://utw.msfaccess.org/>.