Combining health and social protection measures to reach the ultra ...

Access to healthOpen access to research protocolsand results: intellectual propertyand the right to healthArticle by Rodrigo A SalinasThe human right to the highest attainable standard ofhealth requires for its fulfilment access to good qualityhealth care. Equitable access to health technologies,ranging from health promotion activities to drugs and complexinterventions, is a key part of the care provided. An equallyimportant requirement for ensuring good quality care,however, is access to information on the efficacy and safetyof these technologies, coming from scientific research. Anybarrier hampering access to this information should beconsidered as dangerous as those barriers preventing accessto drugs and other health technologies. The Doha Declarationrecognized in 2001 that trade-related intellectual propertyrights should not conflict with the right to protect publichealth. Conflict among these rights, however, affects not onlyaccess to drugs, as emphasized by those mechanismscreated to implement the Declaration, but also access to theinformation on the efficacy and safety of these drugs,particularly by those provisions contained in article 39.3 ofthe Trade-Related Aspects of Intellectual Property Rights(TRIPS) Agreement that reward the non-disclosure of thefindings of medical research.The right to the highest attainable standard of health hasbeen recognized as a human right in the InternationalCovenant on Economic, Social and Cultural Rights, adoptedand opened for signature and ratification by the GeneralAssembly of the United Nations (UN) in December 1966. Ina general comment issued by the Economic and SocialCouncil of the UN in 2000, it is explicitly stated that asubstantive issue arising in the implementation of this right isthe provision of equal and timely access to basic preventive,curative, rehabilitative health services, regular screeningprogrammes and appropriate treatment of prevalent diseasesand disabilities.The new global deal on intellectual property rights, arisingout of the Uruguay Round of Multilateral Trade Negotiationsthat concluded with the signature of the Agreement on TRIPS,and the creation of the World Trade Organization (WTO), inthe eighties, has been denounced in many forums as a barrierfor fulfilling this right. The current system of granting patentsfor new drugs, considered as crucial for encouraging theinvention of much-needed medicines by the pharmaceuticalindustry, has been considered as an obstacle for gettingequitable access to drugs in developing countries 1 . Theseconcerns and a couple of much publicized cases, such as thecase brought against President Nelson Mandela by the SouthAfrican Pharmaceutical Manufacturers Association,eventually led the WTO to produce the Doha Declaration onthe TRIPS Agreement and Public Health recognizing that:“…the Agreement can and should be interpreted andimplemented in a manner supportive of WTO members’ rightto protect public health and, in particular, to promote accessto medicines for all” 2 .Ensuring access to drugs, notwithstanding, is only oneamong other requirements needed for fulfilling the right togood quality health care. A much less explored, but equallyimportant domain is the need for ensuring access toinformation on the efficacy and safety of drugs. Health care,in order to achieve the desirable outcomes it is supposed toget, needs not only careful use of technologies that areapplied by health professionals, and provided by healthservices, but needs also a responsible and accountabledecision-making process leading to the prescription of aparticular procedure for a particular person. This decisionmakingprocess, to be considered a high quality one, needstimely access to adequate and appropriate information on thesafety, efficacy and effectiveness of the whole menu oftechnologies that are available to be prescribed for differentconditions. Good quality information on these domainscomes, in medicine, from methodologically sound andethically responsible research. It is reasonable, thus, toconclude, that the materialization of access to health care asa human right, needs not only actual access to technologiesbut also adequate and timely access to information on thosedomains that allow appropriate decisions to be made at thepoints where these decisions occur.Practising medicine and allied health professions in the21st century, would be unthinkable without access to goodquality data on the efficacy, effectiveness, and safety of healthtechnologies, ranging from health promotion activities tohighly sophisticated medical devices. As part of this movetowards explicit use of scientific data, evidence-basedmedicine has been widely accepted as a new paradigm forteaching and practising medicine, de-emphasizing intuition,unsystematic clinical experience and pathophysiologicrationale as sufficient grounds for decision-making 3 , andGlobal Forum Update on Research for Health Volume 4 ✜ 047