The Geneva Health Forum Abstracts

E. H. Gotuzzo1, E. Gonzalez Lagos2 1Instituto de Medicina Tropical Alexander von Humboldt, 2Instituto de Medicina Tropical, Universidad Peruana Cayetano Heredia, Lima, Peru

Key issues: Over the past decade, Latin America has evolved into a very dynamic area for conducting Clinical Research, particularly with regard to the development of new antimicrobials and vaccines. Between 1995 and 2000, the number of clinical trials executed in the region rose over a factor of ten.
Meeting challenges: Several reasons converge to explain why Latin America is currently perceived as an attractive alternative for clinical research. Firstly, health care systems in many Latin American countries, as well as the availability of adequately trained clinical investigators, have progressed positively since the 1990s, being closer than ever to the available standards in Western societies. Secondly, local investigators have become familiar with international regulations, including Good Clinical Practice and Good Laboratory Practice. Thirdly, throughout adequately constituted Institutional Review Boards, supervision of adherence to and compliance with international regulations is increasingly available. Fourthly, many Latin American governments have so far deliberated and legislated in the field, with clear processes that defi ne regulatory instances and terms for approval processes, as well as those that deal with import and handling of drugs. Fifthly, the extended network of transport and world-wide communication facilitates standards of operation and overseas coordination at reasonable costs, with an increasing number of monitoring companies opening offi ces in Latin America. Additional, long-standing reasons make Latin America an advantageous area to conduct clinical research. These include the large and heterogeneous ethnic and epidemiological profi le of the populations, the important proportion of children, the low exposition to other medication that could interfere with experimental treatments, the high retention rates traditionally reported in Latin American sites and the financial conditions that ultimately allow conducting trials at lower costs than in Western countries. Undeniably, some issues stand as challenging concerns. Despite the respectful adherence to the informed consent process, the individual?s autonomy might be at a certain point constrained if, due to financial limitations and lack of a universal security system, participation in a clinical trial represents the only way to ensure the alternative of a treatment that could not otherwise be afforded, a frequently encountered situation in most Latin American countries. Many other potential constraints are related to the ethical aspects of transcultural research. Whereas ethical principles are oriented toward the respect of core rights that should be universally observed and in that sense should be considered absolute, certain variations in their relative priority or the best way to respect them might also be susceptible to local sensitivities and cultural values. It should be taken into account that in developing countries the cultural differences between doctors and patients, researchers and subjects, can be greater than those encountered on average in Western countries, which can also affect the informed consent process. Interestingly, in Latin America the doctorpatient relationship tends to be much more paternalistic than that seen in the majority of Western societies. This vivid archetype makes it difficult for the subject to distinguish the doctor from the researcher and the messages that pertain to each one, with the subject remaining prone to consent easily when asked by a trusted authority.
Conclusion and recommendations: In conclusion, Latin America displays an increasing capacity to participate adequately in a growing number of clinical trials, but thorough consideration should be devoted to ethical transcultural issues.

O.K. Doumbo1 1Professor, Malaria Research and Training Centre, University of Bamako, Mali

THE IMPORTANCE OF THE NATIONAL LAWS IN THE IMPLEMENTATION OF INTERNATIONAL REGULATION IN DEVELOPING COUNTRIES D. Sprumont1 1Institute of Health Law, University of Neuchâtel, Neuchâtel, Switzerland

Key issues: There is a clear trend toward a greater harmonization of the regulation of clinical trial at the international level. One could even speak about an internationalization of this regulation. Especially in the field of drug trial, the ICH-GCP has become the standard. Even more, it is hard to design a study without referring to the US FDA regulation as well as to the EU EMEA regulation. This trend has been encouraged since the late 1980s by the industrialization of research. The administrative burden of the regulation should be kept at the minimum to facilitate the development of needed therapies and medicines, especially in the developed countries. Yet, if on principles, there is a consensus on the basic rules applying to research involving human beings, as refl ected for instance in the World Medical Association Declaration of Helsinki, there are many issues that require more detailed rules. For instance, to obtain the free and informed consent of a human subject is certainly one of the most fundamental ethical and legal requirements to conduct a clinical trial. Yet, to assess the free and informed consent validity it is first necessary to determine whether the subject has the capacity to consent and whether the information provided to her or him is lawful. Those are two difficult legal issues that require referring to the national legislation as it is in this legislation that, for instance, the notion of legal capacity is defi ned. It is also in the national legislation that the issue of the legal representation of incapacitated persons and of minors will be solved. Concerning minors, the notion of majority is also a matter of the national legislation to address. Minors are not necessarily incapacitated persons and the age of the majority can vary from 15 years (or even younger if the law authorizes their emancipation, for instance, in case of marriage) to 20 years of age. In other countries, women are denied legal competency. These are only limited examples of the importance of the national legislation in the implementation of the international regulations. Similar problems exist on other issues such as the Research Ethics Committees, liability and insurability of clinical trial or also data protection. This legal reality should be better taken into consideration in the implementation of the international regulation of clinical trials. It requires a better understanding of the national legislations and greater respect of them. As such, it is not a break in harmonization, but certainly a step toward a greater respect of the cultural, political and legal diversity of our world. The issue is not about a so-called ?imperialism? of research ethics as developed in the US or in Europe, but more about the building of a real partnership with the developing countries in mutual respect.
Meeting challenges: The key challenge is to provide accurate and up-dated information on the regulation in a given country, especially when there is no specific regulation on clinical trial. This requires referring to the general rules as existing in the Constitution, Civil Code, Criminal Code, Public Health legislation, etc. Such a task goes beyond simple issues of research ethics but needs specialized legal expertise. It seems therefore urgent to educate more lawyers at the national level on the specific legal issues raised by clinical trial, especially for the protection of human subjects.