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Ethical Issues in Pandemic Preparedness

Author(s): A. A. Appiah1, P. L. Forson*1
Affiliation(s): 1Health, African Peace Network, Accra, Ghana
Keywords:

Ethical Issues in Pandemic Preparedness, Public Health Response, Rights, Welfare and Ideals, Transparency and Public Engagement, Resource constraints

Background:

Many of the conferences, meetings, and workshops convened in anticipation of a pandemic have focused on the specific strategies that can be used in fighting such a pandemic. The contributors to this abstract take a different tack and consider the creation of ethical guidelines for governments, health-care systems, and clinicians to be used in planning for and responding to a pandemic.

Methods:

Many critical ethical issues arise in pan¬demic planning, preparedness and re¬sponse including:
1) priority access to medications, vaccines and intensive care unit beds, given the potential shortage of these essential resources;
2) obligations health-care workers have notwithstanding risks to their own health and the health of their families;
3) surveillance, isolation, quarantine and social-distancing measures to be undertaken in a way that respects ethical norms.
In order that response efforts in the event of a pandemic would be hastened, a publicly-discussed ethical framework is essential to maintain public trust, promote compliance, and minimize social disruption and economic loss. There is the need to assist social and political leaders at all levels who influence policy decisions about the incorporation of ethical considerations into national pandemic preparedness plans. Since specific decisions will depend on local circumstances and cultural values, it will be necessary to adapt global guidance to the regional and country-level context, with full respect to the principles and laws of international human rights. Public health measures that involve major costs should be reserved for situations where they can be reasonably expected to make a difference to the consequences of a pandemic. Preparedness planning for a pandemic involves balancing potentially conflicting individual and community interests. In emergency situations, the enjoyment of individual human rights and civil liberties may have to be limited in the public interest.

Results/Conclusions:

Public engagement and involvement of relevant stakeholders should be part of all aspects of planning. In order that public engagement in preparedness planning be meaningful, effective modes of communicating with and educating the public about the issues involved are essential. The principles of outbreak communication are: trust; transparency; communicating to the public early, dialogue with the public; and planning. Advance planning will allow the development of strategies that will reach the entire population and that are linguistically and culturally appropriate. While all countries must make reasonable efforts to prepare for a pandemic, differences in access to resources mean that what is reasonable for one country may not be reasonable for another. In developing countries, limited resources and immediate health-care needs may make it difficult to develop and implement comprehensive plans. In some cases, it may be possible to generate resources by using available funds more efficiently. The process for setting priorities and promoting equitable access involves civil society and other major stakeholders in the decision-making process so that decisions about the criteria to be used in allocating scarce resources are made in an open, transparent, and inclusive manner. Despite the criteria selected to govern the allocation of therapeutic and preventive measures, certain basics will be essential in all plans:
1) facilitating access to the highest level of treatment;
2) providing clinicians with clear and transparent screening and treatment protocols;
3) proposing prioritization criteria related to the maintenance of a functioning health-care system as needed in a crisis situation.

The Pneumococcal Advance Market Commitment: Innovative Finance to Help the Poor

Author(s): T. Cernuschi*1, M. M. K. Krawczyk2
Affiliation(s): 1 Policy and Performance, 2Media and Communications, GAVI Alliance, Geneva, Switzerland
Background: The Advance Market Commitment (AMC) is a new approach to public health funding designed to stimulate the development and manufacture of affordable vaccines tailored to the needs of developing countries. The pilot AMC against pneumococcal disease was launched in June 2009 with a collective US$ 1.5 billion donor commitment. The overarching goal is to reduce morbidity and mortality from pneumococcal diseases by bringing forward the availability of effective pneumococcal vaccines tailored to the developing world at a predictable and affordable price for countries for the long-term. Thanks to innovative finance, the GAVI Alliance is speeding up the availability of new and affordable vaccines tailored to developing countries. Innovative financing mechanisms such as AMC provide GAVI with a new, predictable and sustainable source of funding for health. Pharmaceutical companies target their R&D investment to products that will produce a fast commercial return. Consequently, many vaccines that could eradicate diseases affecting poor countries do not exist. Also, vaccines targeting diseases affecting both the rich and the poor worlds are often of inadequate formulations, too expensive and available in insufficient quantities to meet poor countries’ needs.
Methods:

The AMC is a binding contract by a government used to guarantee a viable market if a vaccine is successfully developed. Consequently, the market for vaccines for neglected diseases would be comparable in size and certainty to the market for medicines for rich countries. The binding contract guarantees a pre-agreed price for the first doses of vaccines sold to developing countries (AMC price). In exchange, participating companies must guarantee supply for the long term under a pre-agreed low price (tail price). A pilot AMC has been designed for pneumococcal vaccines to demonstrate the feasibility of the AMC mechanism. The overarching goal of the Pneumo AMC is to prevent an estimated 7 million deaths by 2030. The Pneumo AMC will encourage development and availability of vaccines that meet developing country needs. It will also accelerate uptake through a predictable price for countries sustainable in the long run.

Results/Conclusions:

Advance Market Commitments have been designed to address the asymmetries between rich and poor vaccine markets: an AMC has the potential to stimulate private investment for development and large scale production of vaccines for developing countries. The specific design of each AMC may well vary from case to case. In order to be effective, in fact, each AMC must be carefully crafted according to its specific goals and the main characteristics of the disease market involved (including the particular the stages of vaccine development, the number of potential suppliers, other existing incentives to R&D). The first AMC has been launched in June 2009. It will now be important to see the outcome of evaluation studies assessing in detail its impact. It is estimated that introduction of pneumococcal vaccine through the AMC could save over 7 million lives by 2030. GAVI eligible countries could access the vaccine in 2010.

Strengthening Regulatory Capacity in Africa for the Registration of New Drugs for Neglected Diseases

Author(s): M. Moran*1, J. Guzman1
Affiliation(s): 1Health Policy Division, The George Institute for International Health, Sydney, Australia
Keywords: ND, neglected disease; PDP, product development partnership
Background:

DNDi aims to develop new drugs and treatments for neglected diseases (NDs) and to ensure equitable access to effective therapeutic options for patients in need in developing countries.

Methods:

DNDi commissioned to the George Institute for International Health a study of the mechanisms and strategies available today to support registration of new drugs for NDs in Africa. The report was reviewed by international regulatory experts. It offers recommendations to ensure the urgent approval in developing countries of new ND drugs and treatments that are safe, effective and of quality.

Results/Conclusions:

In the past 10 years, several product development partnerships (PDPs) have been created to fill the gaps in research and development of drugs, diagnostics and vaccines for NDs that affect predominantly developing countries. Similar to any new drug, all individual ND treatments developed by PDPs must be registered by national drug regulatory authorities as safe, effective and of quality before they become available for patients. However, regulatory authorities in most developing countries, and particularly in Africa, lack human and technical resources to assess the safety, efficacy and quality of new medicines. Therefore, most new products for NDs are usually submitted first to prominent regulatory authorities in developed countries, such as the US Food and Drug Administration (FDA), the European Medicines Agency (EMEA), the UK Medicines and Healthcare Products Regulatory Agency (MHRA) or the Swiss Agency for Therapeutic Products (SwissMedic), for registration. This is the case even for products that are likely to have little or no use in developed countries but are crucial for developing countries, such as new drugs for human African trypanosomiasis. This regulatory practice brings decades of regulatory experience for assessment of ND products. However, first approval of ND drugs by well-resourced regulatory authorities also has some limitations, such as delayed access for target patients in Africa, lack of knowledge of NDs with potential consequences in clinical trial design and potential inappropriate risk-benefit assessment for use in developing countries. What would therefore be the best registration strategy for the approval of a new drug to treat human African trypanosomiasis, a disease that mainly affects patients in central and west Africa? What would be the best way to support African regulatory authorities in their evaluation of new drugs specifically developed to treat their own populations? How should essential standards for the conduct of clinical trials be defined? How should the risks and benefits of drugs be assessed in a manner that is appropriate to the needs of the patients in developing countries, the severity of the disease, and the  availability (or not) of alternative treatments, while ensuring that the medicines are safe, effective and of quality?
As regulators are only responsible for the registration of drugs for their own populations, ND product registration has to accommodate existing national regulations and approaches, rather than the other way around. However, given the experience and resources of large regulators in developed countries, more could be done to share technical knowledge to assist African patients and regulators. There is a need to think about new mechanisms and strategies, based on international cooperation, to ensure the urgent approval in developing countries of new ND drugs and treatments, which are safe effective and of quality. Several proposals could facilitate ND drug registration for Africa, with the objectives of (1) managing scarce regulatory resources in the short term to fill the capacity gap while African regulatory agencies move through their growth period, and (2) strengthening African regulatory agencies in the medium to long-term so that they can conduct their own regulatory reviews of novel ND drugs.

Prevalence of HPV Serotypes in High Grade Intraepithelial Cervico-Uterine Lesions in Cameroon: A Pilot Study

Author(s): Z. Sando*1, J. Pache2, A. Doh3, O. Folem3, L. Rubbia-Brandt2, T. Mc Kee4
Affiliation(s): 1Ministry of public health Yaounde-Cameroon, Gyneco-obstetric and paediatric hospital, Yaounde, Cameroon, 2Pathology, Hôpital Cantonal Universitaire, Geneva, Switzerland, 3Ministry of Public Health, Gynaeco-obstetric and paediatric hospital, Yaounde, Cameroon, 4Pathology, Gyneco-obstetric and paediatric hospital, Hôpital cantonal Universitaire, Switzerland
Keywords: Human papilloma virus, serotypes, Cervical cancer
Background:

Malignant lesions of the uterine cervix constitute a major public health problem in the world, especially in the developping countries.Human papilloma virus (HPV) was first associated to cervical cancer more than twenty years ago. There are about twenty serotypes of HPV implicated in the pathogenesis of cervical cancer. Variations are observed in the geographic distribution of these serotypes even in most area types 16 and 18 are to be found.In the absence of data from Cameroon on HPV types, we deem it great importance to carry out a study before the introduction of a vaccine into our immunization program.The main objective was to determine the prevalence of the serotypes of HPV in high grade intraepithelial lesions of the uterine cervix in Cameroon

Methods:

Recruitment of patients took place from 1st January to 31 st December 2008. Patients with routine conventional pap smear requested for check up, chowing high grade lesions were invited for sample collection. After accepting the consent form, the trained pathologist or gynaecologist carried out visual description of the cervix, and collects exo and endocervical samples. Collected samples were introduced into a transport medium (Thin prep sollution). The transport medium was sent to the service of Pathology, Hôpitaux universitaires de Genève for a control smear using monolayer technique and for determination of sample with oncogenic patential HPV, hybrid capture. Then sequencing of all types of HPV was done.

Results/Conclusions:

31 samples were transported, with 2 samples used as control. The 2 samples had no dysplasia on conventional smear, and on thin prep. Of the 29 remaining samples with high grade lesions, there was no HPV detected on one case. For the 28 samples, the HPV serotypes were detected with the following frequency: 36% for HPV 16, 32% for HPV 18, 8% for HPV 45, 4% for HPV 33, 4% for HPV 35, 4% for HPV 68. The association HPV 16, 45 was seen on 4% of cases and the association HPV 35,53,74 also in 4% of cases. HPV 16 and HPV 18 association was seen in 69,23% of cases. In conclusion, HPV serotypes 16 and 18 are predominantly detected in high grade lesions of the uterine cervix in Cameroon, their association are seen in 69,23% of case. The vaccines against those serotypes may be useful for population. There is also a variety of HPV serotypes, HPV 45 being among the other most frequent types.

Analyzing Malaria Literature (1955-2005) for Policy Makers

Author(s): D. Srivastava*1, R. Kant1
Affiliation(s): 1Division of Publications and Information, Indian Council of Medical Research, New Delhi, India
Keywords: Malaria, Database, productivity, Indicators, Literature Survey, New Database
Background:

With the recent breakthrough in Genomics and Proteomics and availability of quantum of information on Human, Mosquito and Parasite Genome and the application of advanced molecular and biotechnological techniques the research has entered in to a new arena with more prospects on vaccine development, drug delivery system, diagnostics, alternative methods of control and evaluation of newer insecticides and drugs. Given the significant growth in the malaria research infrastructure and malaria research investments in the country, India needs to monitor and measure its performance in malaria research on regular basis. This requires building suitable indicators of malaria research performance, designed to understand the dynamics of research at institutional, sectoral, geographical and subject level. Some indicators are required for depicting how Indian research is performing vis-à-vis a select other similarly placed countries and against countries from the developed world.

Methods:

The database (on a CD, through specially developed software using Microsoft Visual Studio 2005 with back end MS Access.) have been developed on the basis of records captured from Science Citation Index (Expanded-online version), MEDLINE, Ovid (Global Health), Tropical Disease Bulletin and Indian Science Abstracts, and will facilitate a quick access to all the malaria related work carried out during last 50 years (1955-2005) published in a journal. Where-ever it was needed; the data have been completed manually also and is first of its kind to provide a consolidated and comprehensive Bibliographical Database (MAL-PUB) on Malaria Research Papers, in the field of malaria around the Globe. The software has two versions: User Version is having facilities for simple and advance search, summarization, saving in desire format & printing. The Full Version is having additional facilities, such as, data editing, data updating, data entry, deletion or addition of records etc.

Results/Conclusions:

The total numbers of papers published during 1955-2005 is 122055. During 1996-2005 the number of papers was at it’s maximum with 47.21%. The cumulative publication share in world research output indicated an exponential growth of papers from 3.34 (1955-65) to 47.21 (1996-2005). The distribution of the research levels of the malaria papers, with papers in three other biomedical sub-fields – AIDS, cancer and respiratory medicine indicates the malaria papers are the most basic of the four. This suggests that much still has to be learned about the fundamentals of the disease, whereas for the other research sub-fields, the emphasis of research is very much on the development of new and better drugs. The total number of countries involved in malaria research has increased from 130 (1981-85) to 135 (2001-05). India has maintained it’s position among the top 4 countries through out the period of study (1981-2005) in the bracket of USA, UK, and France. The average growth rate of developing countries in top 20 is from (-)14.39 to (+)29.35 during successive years. India and Brazil are the top most growing countries, with annual growth rate of (-)14.39 to (+)15.12. Analysis indicates, an increase in the relative effort devoted to modern research in the field of control measures and understanding of vectors, parasite & antimalarials eg Artemesinin (ACT), Genome or Gene Studies, Malaria Vaccine, P. falciparum and Mosquito or Vector Control. Vaccines research has shown an increase during 1986-95, and has remained at about 22% of the total world average. In the field of parasite biology most of the efforts are concentrated on P. falciparum whereas the papers on P. vivax have shown only a marginal increase.Report of P. knowlesi, the monkey malaria of South-east Asia made new developments. Use of Rapid diagnostic kits was adopted for research areas in later years.

GHF2006 – PL05 – Global Gaps in Research, Capacity Building and Human Resources

Session Outline

Plenary session, Friday, September 1 2006, 9:00-10:30
Chair(s): Jean-Louis Carpentier, Switzerland, Tikki Pang, Switzerland
Putting Research Evidence into Practice
Nirmal Kumar Ganguly, Director General, Indian Council of Medical Research, New Delhi, India  
Manuel Dayrit, Human Resources for Health, World Health Organization, Geneva, Switzerland   
Towards Improving Transparency in Clinical Trials
Odette Morin, Director, Regulatory and scientific Affairs, International Federation of Pharmaceutical Manufacturers & Associations (IFPMA), Geneva, Switzerland
Can Research Make a Difference in Global Access to Health?
Stephen A. Matlin, Executive Director, Global Forum for Health Research, Geneva, Switzerland 

Session Documents

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Session Report

Submitted by: Anne May (ICVolunteers)

Image: Dominic Monnier

Plenary V addressed the current challenges and conditions for effective capacity building in the health workforce as well as medical research to improve health and give access to health care in developing countries.

Dr. Manuel Dayrit, of Human Resources for Health at World Health Organization (WHO), discussed the current challenges and conditions for effective capacity building in the health workforce. Although Mr. Dayrit's focus was on human resources for health, he insisted throughout his presentation on the fact that capacity building was constantly taking place in a much broader context of socioeconomic and political circumstances, institutions, and involved many actors from different horizons. Hence, it is essential, in order to be effective, that capacity building be systemic. However, failure to address the capacity constraints (political, institutional) limiting the achievement of overall capacity building project objectives has repeatedly been shown.

Mr. Dayrit defined "capacity building" as "a process by which individuals, groups, institutions, organizations and societies enhance their abilities to identify and meet development challenges in a sustainable manner." As set forth by WHO's late Director General, Dr. Lee Jong-wook, the ultimate goal of capacity building is "to ensure access to a motivated, skilled, and supported health worker by every person in every village everywhere."

The health workforce, Mr. Dayrit noted, must be understood as "all people engaged in actions whose primary intent is to enhance health," not only doctors and nurses, but also such diverse professionals as economists, drivers, cooks, etc.

Mr. Dayrit, provided various illustrations of the strong positive correlation observed worldwide between the proportion of health workers in the population and population's health measured by various indicators. The latest WHO World Health Report (2006) provides ample evidence supporting the view that shortages of health workers in certain areas in the world must be addressed as one key step to improve overall health. The causes of such shortages are many and diverse and may be grouped into three tiers: the entry level, including planning, education and retirement; the workforce level, including supervision, adequate compensation, continuing education; and the exit level, limiting emigration, changes in career and ensuring the health of the workforce. Only a strategy tackling these three aspects (a "lifespan strategy") may lead to effective sustainable results. To illustrate this point, Mr. Dayrit described the case of Thailand where multiple strategies have helped to improve the retention of trained health workers in rural areas. With concerted regulatory, economic, educational, managerial and social strategies, the country has indeed managed to shift the ratio of health workers in Bangkok v. those in the northeast of the country from a 22:1 ratio in the eighties to a 10:1 ratio in 1999.

In conclusion, Mr. Dayrit reiterated the view that capacity building efforts will succeed only where they take adequate account of the prevailing local politics, economics and institutions and are country-owned rather than donor-driven. To that effect, he noted that countries have to take the lead in developing capacity building efforts and that donors should harmonize their support around the countries' priorities.

Ms. Odette Morin, Director of Regulatory and Scientific Affairs of the International Federation of Pharmaceutical Manufacturers and Association (IFPMA), presented the newly created IFPMA Clinical Trials Portal, launched in 2005, that is the first portal to provide public, online information about on-going and completed clinical trials sponsored by pharmaceutical companies worldwide.

The portal was developed as a response to various pressures for improved trial transparency. Through their associations, the pharmaceutical companies have taken a joint position on the disclosure of clinical trial information that has led to the creation of the portal. Pursuant to ongoing public pressures, the number of clinical trial postings on the portal has almost doubled during the first months of its launch.

The portal is not a database but is structured as a platform giving access to various sources which centralize information, such as national industry associations, governments or international organizations. It allows multiple-criteria searches in English, French, German, Japanese and Spanish.

The portal is not only useful to doctors and patients, it is also an essential tool, as was discussed after Ms. Morin presentation, to inform health systems management. Of course, the portal may be only as good as the information made available by companies and governments. It was hence emphasized that national registries should be improved in many regions to improve coverage.

 

Mr. Stephen A. Matlin, Executive Director, Global Forum for Health Research, discussed the crucial role of health research in ensuring that people everywhere have access to health. Mr. Matlin first provided an overview of the changing face of health problems worldwide. Although infectious, communicable diseases (CDs) remain the major health burden in Africa, there is an overall increase in non-communicable diseases (NCDs) among low and medium income countries (LMICs). Health research agenda should adapt to these evolving needs.

Health research, Mr. Matlin highlighted, is not limited to biomedical research and the development of new products. The health research agenda should also focus on systemic aspects such as strengthening health policy and systems, the promotion of health equity, the study of social and other determinants of health including the availability of public transport networks for access to health resources.

It is widely recognized that there is a major lack of spending on health research for the needs of developing countries, both by HICs and by LMICs themselves. Although global health research expenditure is growing at a rapid pace, only a small proportion of it (less than 5% in the 1990s) is devoted to diseases and health problems that are endemic in LMICs. As a result, during the last few decades, very few new products for diseases that are mainly endemic in poor countries were registered for clinical use. In parallel, health systems and health research capacities in LMICs have not been sufficiently developed.

In order to tackle the disease burden in LMICs, concerted approaches should be implemented by both LMICs and HICs. HICs should focus on research that generates leads for LMICs and support country-based research and capacity building in LMICs. LMICs should similarly support their own research capacity and utilization. They should focus on the development of national health research systems, foster innovation and ensure that local research capacity addresses local priority health needs.

There is an emergence of innovating developing countries, such as Brazil, China, India and South Africa. These countries have demonstrated a growing capacity to undertake health innovation and assume an increasing role in the development of new drugs, vaccines and diagnostic tools, as well as of new techniques and new policies in health systems and services. One characteristic of these countries is that they manage to span the spectrum from innovative research to product delivery.

One major source of funding for, in, and by, LMICs is philanthropy. Over the 1993-2003 period, the 50 most generous philanthropists collectively donated over 50 billion USD. Public-Private Partnerships (PPPs) are playing a growing role in the financing of health research for LMICs. PPPs' Research & Development (R&D) expenditure has increased dramatically since 2000 and 75% of all neglected disease R&D projects are currently conducted by PPPs. The public sector should devote an increased share of available R&D resources to the health needs of developing countries, as they have fallen short of meeting the the targets set at the 1990 Commission on Health Research for Development (2% of government health budget on essential health research).

Mr. Matlin concluded by highlighting areas to which government financing of health research for development should focus. In HICs, greater priority should be given to national research programs and more health research should be included in bilateral and multilateral channels. In LMICs, in additional to giving greater priority to national health programs, capacity building for national health research systems and innovation should be emphasized.



Can Research Make a Difference in Global Access to Health?

Author(s): Stephen A. Matlin1
Affiliation(s): 1Executive Director, Global Forum for Health Research, Geneva, Switzerland
Key issues:

Health research has several crucial roles to play in ensuring that people everywhere have access to health. These roles include the creation of knowledge, tools and products; ensuring that new products such as drugs, vaccines, diagnostics and appliances are created, especially to deal with diseases and health problems that are mainly endemic in developing countries; providing evidence to establish equitable financing systems and well-functioning health systems to ensure affordability, access and uptake of interventions, even by the poorest and most marginalised in society. It is widely recognized that far too few resources are devoted to addressing the health needs of developing countries. As a result of this 10/90 gap: (1) during the last few decades, very few new products for infectious diseases were registered for clinical use, with the private sector inadequately addressing the need for new or improved therapies for diseases that are mainly endemic in poor countries; (2) the development of health systems in low- and middle-income countries (LMICs) has not been effectively supported by health research to inform policy and improve programme delivery; and (3) the research capacities of LMICs to address national health priorities have not been sufficiently developed.

Meeting challenges:

The public sector, which overall accounts for nearly half of the total global spending of over US$ 100 billion per year on health research, has a crucial role to play in financing health research to address this 10/90 gap. Governments in both developed and developing countries need to contribute to this effort, in proportion to their capacities and resources.

Conclusion (max 400 words):

In particular, the public sector in high-income countries can contribute in a number of important ways. It can devote an increased share of the available research resources to the health needs of developing countries, including directing more basic research towards creating new drug leads for important diseases found mainly in LMICs. The public sector can also substantially increase support for public-private partnerships in the health field that are now creating an important pipeline of potential new products. The public sector of developed countries also has a crucial role to play, by encouraging and supporting research capacity building and utilization in LMICs. At the same time, the public sector in LMICs themselves must also increase its support for health research. Notably: support the development of a national health research system, to ensure that local research capacity to address priority health needs is built and utilized; especially in the case of innovating developing countries (IDCs) such as Brazil, China, India and South Africa, develop policies and devote resources to ensure that the IDCs use part of their newly evolving capacity to address their own and other developing countries endemic diseases, rather than focusing exclusively on products that target the more lucrative markets in developed countries.

Towards Improving Transparency in Clinical Trials

Author(s): Odette Morin1
Affiliation(s): 1Director, Regulatory and scientific Affairs, International Federation of Pharmaceutical Manufacturers & Associations (IFPMA), Geneva, Switzerland
Summary (max 100 words): The IFPMA Clinical Trials Portal www.ifpma.org/clinicaltrials is the first internet search engine to link to online information about on-going and completed clinical trials sponsored by research-based pharmaceutical companies worldwide. Created to help fulfill the pharmaceutical industry’s commitment to increase the transparency of clinical trials, the Portal provides doctors and patients with easy access to online information about clinical trials of drugs and vaccines. As part of IFPMA’s ongoing efforts to improve the Portal, it now allows multiple-criteria searches in French, German, Japanese and Spanish, as well as English, via an easy-to-use interface. The Portal incorporates a powerful multilingual synonym function, which allows use of common names for medical conditions, circumvents spelling mistakes and permits searches to be expanded to include related conditions.

GHF2006 – PS14 – Research & Access to Health: Ethical Concerns

Session Outline

Parallel session PS14, Thursday, August 31 2006, 16:00-17:30
Chair(s): Nirmal Kumar Ganguly, India, Alexandre Mauron, Switzerland
Eduardo H. Gotuzzo, Instituto de Medicina Tropical, Universidad Peruana Cayetano Heredia, Lima, Peru 
Ethical Aspects of Clinical Research in Africa: A Positive Experience from Mali
Ogobara K. Doumbo, Professor, Malaria Research and Training Centre, University of Bamako, Mali  
The Importance of the National Laws in the Implementation of International Regulations in Developing Countries
Dominique Sprumont, Institute of Health Law, University of Neuchâtel, Neuchâtel, Switzerland

Session Document

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Session Report

Submitted by: Shibani Bandyopadhyay (ICVolunteers); Contributors: Tatjana Schwabe (ICVolunteers)

The symposium on "Research and Access to Health: Ethical Concerns" has highlighted the fact that strong laws are a powerful tool to protect participants in experimental clinical trials. Presentations on Clinical Research in Latin America and the importance of national laws in the implementation of international regulation in developing countries introduced some of the complexities of ethics involved in clinical trials.

The co-chair, Dr. Alexandre Mauron from the Medical Faculty of the University of Geneva, Switzerland, introduced the topic of ethical concerns in health research, stressing that clinical trials had become a global activity, requiring discussion about ethics in research to be a priority.

Dr. E. H. Gotuzzo from Instituto de Medicina Tropical Alexander von Humboldt in Lima, Peru presented his paper on "Clinical research in Latin America: constraints and opportunities". He pointed out that currently between 11 - 25 % of all clinical trials (CT) are being conducted in Latin America, involving numerous sites and professionals in the trials themselves and the related ethical review work. Dr. Gotuzzo first listed the advantages of conducting clinical trials in Latin America:

  • A vast heterogeneous study population with patients suitable for many CTs available in the mega cities of Argentina, Mexico, Brazil and Colombia;
  • Minimal drop out rates;
  • Trained personnel with good clinical practices;
  • Potential markets for pharmaceutical industries;
  • Possibility to conduct year-round trials on seasonally induced diseases (e.g. diarrhoea or respiratory diseases) in combination with countries in the Northern hemisphere;
  • Dr. Gotuzzo pointed out that most clinical trials in Latin America are being carried out by private industry, while only about 100 trials are being conducted by the US-American National Institutes of Health (NIH), universities or other public institutions. About 80 % of the clinical trials in Latin America analyse new vaccines against rotavirus, papilloma virus or HIV.

However, clinical trials in Latin America face a number of challenges including:

  • Lengthy approvals due to government regulations;
  • Corruption (as large sums of money are often involved in CTs);
  • Forged CT results;
  • Low priority of clinical trial output product;
  • Severe unrest threatening the continuation of  CTs as seen in Argentina (2001), Venezuela or Peru (1990);
  • Ethical issues such as acquisition of study subjects and informed consent.

Regarding the last point, Dr. Gotuzzo explained that in the paternal patient-doctor relationship in Latin America, informed consent of patients was an unfamiliar concept. During the question and answer session, the issue of informed consent by vulnerable, handicapped or mentally ill patient was briefly raised. Answering a question from the audience, the speaker argued that the hope to improve the health situation was the main reason for countries with limited resource and increasing drug resistance to participate in CTs.

In his conclusion, Dr. Gotuzzo urged for more transparency and clear requirements, amongst others through the strengthening of health systems, to determine whether a clinical trial is carried out according to appropriate ethical standards. CT participants-and possibly also the institutions and countries in which these CTs are conducted-should benefit more directly from the CTs as today, frequently, the CTs only benefit western development.

In the absence of Dr. Doumbo from Mali, Dr. Hassan Mshinda, Director of the Ifakara Health Research and Development Centre in Tanzania kindly agreed to talk about his experience regarding ethical is regarding clinical trials in Africa. In partnership with the Special Programme for Research and Training in Tropical Diseases (TDR) and the WHO, skills in applying ethical standards in CTs have been developed by the training of staff in Standard Operating Procedures (SOP), Good Clinical Practice (GCP) and ethics.

Dr. Mshinda pointed out that Tanzania is taking several steps to ensure that ethics standards are applied in clinical trials. Ethical clearance is mandatory and a licence is required for each product to be tested in a CT. The composition of the ethical board has changed to include independent legal and gender representatives in addition to professional scientists and clinicians. Tanzania accepts the responsibility for all research work undertaken in the country, for example by refusing to engage foreign nationals as principal investigators of any research work or by including an independent country representative in the data monitoring safety board of a multi-centric study by a foreign pharmaceutical company. This is crucial, as a local investigator will, unlike most foreign stakeholders, still be there to take responsibility should a problem arise after completion of a research protocol. He also pointed out that in this particular biosocial context, verbal consent was largely prevalent over written consent. Implementation of community consent also raises largely unexplored difficulties. Such socio-cultural issues can pose problems for ethical guidelines requiring individual and written informed consent.

Dr. Dominique Sprumont, Director of the Institute of Health Law at the University of Neuchatel, Switzerland introduced the "Importance of the National Laws in the Implementation of International Regulations in Developing Countries". At the beginning of his talk, he pointed to the complex documents regulating research on an international level such as the Geneva Convention, the Nuremburg Code, the Declaration of Helsinki, the International Convention on Civil and Political Rights, WHO International Ethical Guidelines and European Union (EU) Directives. Both the EU directives and the National Law aim predominantly at protecting the subjects of clinical trials. Another body to issue guidelines on Good Clinical Practice (GCP) was the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). In its principle 26, it demands that all CTs be conducted under the supervision of an Institutional Review Board (IRB) and Independent Ethics Committee (IEC), both of which have to be approved by the "competent body". What constitutes a competent body is left open to interpretation in the document and definitions differ from country to country. Another area, where definitions differ is that of informed consent. Dr. Sprumont presented examples from Benin, Mali and Senegal, where the definitions of child, incompetent adult and legal representative vary. Even across Europe, concepts concerning the competent authority for consent and legal competency are not uniform. In the light of the heterogeneous world of many diverse but equal sovereign countries, Dr. Sprumont concluded that national regulation was the only way to provide specific rules on key issues in biomedical research. He stated that the respect for national regulations was essential for partnership in international research and capacity building.

Dr. Mauron concluded the session by emphasising the importance of including only fully informed participants in clinical trials. To avoid the disseminating of misleading information, clinicians and research workers need guidance from other disciplines, including legal experts, to prepare the information that is to be shared with patients.

Clinical trials are the most important tool in medical research to find the best therapy or method for intervention. While CTs have so far been mostly ruled by biostatistics, more emphasis is now being placed on human rights and ethical concerns. Since research is becoming more and more industrialised, national law has to ensure that international regulations and ethics guidelines are implemented in each country and hence the need to ensure that research protocols are compatible with different local laws. This in turn leads to the question of which research institute has the final say in multi-centre research.



Clinical Research in Latin America: Constraints and Opportunities

Author(s): Eduardo H. Gotuzzo1, E. Gonzalez Lagos2
Affiliation(s): 1Instituto de Medicina Tropical Alexander von Humboldt, Lima, Peru 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 define 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 offices 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 profile 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 (max 400 words): 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.