Transcript Ethical Governance and Benefit Sharing in Biomedical Research

Ethical Governance and Benefit
Sharing in Biomedical Research
Alex Wellington
Department of Philosophy
Ryerson University
Controversies in Research Ethics
• Persons without sufficient Decision Making
Capacity to give informed consent for themselves
• Children
• Embryos
• Prisoners
• Vulnerable Persons
• Persons in Developing Countries
• Issues: Proxy Consent, Coercion, Exploitation,
Commercialization
• Situations: Clinical Trials
• Genetic Databanks
Ethical Frameworks – Restrictive
• A1. Research is only justifiable when research
participants can consent to covenant between
researcher and patient
• NO PROXY CONSENT
• A2. Only research which (directly) benefits
(participating) patients as part of their care is
justifiable
• NO NONTHERAPEUTIC RESEARCH
• Advocate: Paul Ramsey, The Patient As Person
Ethical Frameworks - Contrasting
• B.1: Proxy Consent for participation in research
justifiable if the participant ought to wish, as a
social being, that others would be provided with
human goods (such as health)
• B.2: Given that all humans have an obligation to
seek human goods (such as health) for others,
participation in research is obligatory
• Advocate: Richard McCormick , “Proxy Consent
in the Experimentation Situation”
Ethical Frameworks - Modified
• C.1: Research is justifiable if it will benefit the
category or class of disease sufferers to which
participant belongs, i.e., people who do suffer, or
who will suffer, from the specific condition being
studied
• Example: Persons with Breast Cancer
participating in Breast Cancer Research
• C.2: Proxy consent acceptable for those who do
belong to the group of intended beneficiaries
• Examples: Persons suffering from Alzheimer’s,
childhood diabetes, or childhood leukemia,
participating in research targeting that condition
Ethical Frameworks - Permissive
• D.1: Research which will benefit humanity, or
society as a whole, should be allowed, provided
that there are sufficient benefits and that risk to
participants is minimized
• D.2: Proxy Consent is allowable
• Examples: Research on Prisoners, for reasons of
convenience, since they are a captive population
and there is extensive record keeping already
Ethical Frameworks – Helsinki
Declaration
• World Medical Association, Declaration of
Helsinki: Ethical Principles for Medical Research
Involving Human Subjects
• Adopted June 1964 and Amended regularly
• <http://www.wma.net/en/30publications/10policies
/b3/17c.pdf>
Ethical Frameworks – National
Commission
• National Commission for the Protection of Human
Subjects of Biomedical and Behavioral Research
• Tasked with making recommendations for
regulations for the Department of Health and
Human Services to ensure protection of rights
and welfare of human subjects
• Section 201(a) of Pub. L. 93-348, signed into law
July 12, 1974
• Reference:
<http://www.hhs.gov/ohrp/documents/19790525.p
df>
Belmont Report
• National Commission for the Protection of Human
Subjects of Biomedical and Behavioral Research
identified and articulated basic ethical principles
in Belmont Report, April 18, 1979
• Respect for Persons
• Beneficence
• Justice
• Applications: Informed Consent, Assesment of
Risks and Benefits, Selection of Subjects
• <http://www.hhs.gov/ohrp/humansubjects/guidanc
e/belmont.htm>
Example of Specific Ethical Principle
• Reasonable Availability Principle from Council for
International Organizations of Medical Sciences
(CIOMS) International Ethical Guidelines
• “As a general rule, the sponsoring agency should
agree in advance of the research that any product
developed through such research will be made
reasonably available to the inhabitants of the host
community or country at the completion of
successful testing. Exceptions to this general
requirement should be justified and agreed to by
all concerned parties before the research begins.”
• Guideline 10
Fair Benefits Framework
• Benefits to Participants DURING research,
including Health Improvement, Collateral Health
Services
• Benefits to Participants AND Population DURING
research, including Public Health Measures,
Employment and Economic Activity
• Benefits AFTER research, such as Capacity
Development (Capacity Building), Longer term
collaboration, and FINANCIAL REWARDS
Fair Benefits Framework Continued
• TRANSPARENCY and ACCOUNTABILITY
• Central Repository of Benefits Agreements, for
purposes of comparison
• Community Consultation
• Reference: Ezekiel Emanuel and Participants in
2001 Conference on Ethical Aspects of Research
in Developing Countries, Hastings Center Report,
May-June 2004, 17-27
Ethical Frameworks – Genetic
Research
• Benefit Sharing
• Example: Human Genome Organization Ethics
Committee – Statement on Benefit Sharing
• Builds upon Statement on the Principled Conduct
of Genetic Research (1996)
• Recognition that the human genome is part of the
common heritage of humanity
• Adherence to international norms of human rights
• Respect for the values, traditions, culture and
integrity of participants
• Acceptance and upholding of human dignity and
freedom
HUGO Recommendations
• (1) That all humanity share in, and have access
to, the benefits of genetic research
• (2) That all benefits not be limited to those
individuals who participated in such research
• (3) That there be prior discussion with groups or
communities on the issue of benefit sharing
Recommendations Continued
• (4) That even in the absence of profits, immediate
health benefits as determined by community
needs should be provided
• (5) That at a minimum, all research participants
should receive information about general
research outcomes and an indication of
appreciation
• (6) That profit-making entities dedicate a
percentage (e.g., 1-3 percent) of their annual net
profit to healthcare infrastructure and/ or to
humanitarian efforts
UNESCO Declaration
• UNESCO International Declaration on Human
Genetic Data, Article 19, Sharing of Benefits
• “(a) In accordance with domestic law or policy
and international agreements, benefits resulting
from the use of human genetic data, human
proteomic data or biological samples collected for
medical and scientific research should be shared
with the society as a whole and the international
community.”
Examples of Benefits
• (i) Special Assistance to participating individuals
and groups
• (ii) Access to Medical Care
• (iii) Provision of new diagnostics, facilities,
treatments or drugs stemming from research
• (iv) Support for health services
• (v) Capacity Building for research
• (vi) Capacity Building for collecting and
processing human genetic data
Reference
• HUGO Ethics Committee – Statement on Benefit
Sharing, Eubio: Journal of Asian and International
Bioethics, Volume 10, 2000, 70-72
• United Nations Educational, Scientific and
Cultural Organization, International Declaration
on Human Genetic Data
• <http://portal.unesco.org/en/ev.phpURL_ID=17720&URL_DO=DO_TOPIC&URL_SE
CTION=201.html>
Roots in the CBD
• Roots of Benefit Sharing Concepts in Convention
on Biological Diversity
• Treaty signed by 150 government leaders during
the 1992 Rio Earth Summit (not yet ratified by the
US)
• Objectives: Conservation of Biological Diversity
• Sustainable use of biodiversity
• Fair and Equitable Sharing of Benefits arising
from utilization of genetic resources
Convention on Biological Diversity and
Bonn Guidelines
• Follow to Convention on Biological Diversity –
Bonn Guidelines on Access to Genetic Resources
and Fair and Equitable Sharing of the Benefits
Arising Out of Their Utilization (2002)
• Voluntary Guidelines which aspire to motivate
governments to design legislation and other
policy measures
• Emphasis on importance of PRIOR INFORMED
CONSENT for use of “community” resources
• Reference:
http://www.cbd.int/doc/publications/cbd-bonngdls-en.pdf
Benefit Sharing Issues
• What is owed to populations or communities, as
benefits in recognition of participation in medical
research or contributions to genetic databanks?
• What is owed to individuals who take part in
research trials or who contribute to genetic
databanks?
• What kinds of benefits should be provided?
• Should there be financial compensation?
Aspirations
• Goal is not just to include people in clinical trials,
genetic databanks or bioprospecting initiatives,
but to “include them well”
• Reference: Marilyn Strathern, “Accountability…
and Ethnography”, in Marilyn Strathern, editor,
Audit Cultures: Anthropological Studies in
Accountability, Ethics, and the Academy, 2000,
279-304
Giving Voice
• Participants and contributors should be “given a
voice” in decision making, for issues affecting
ownership of data, access to information, and
uses of commercialized products and services
• Reference: Jon F. Merz, David Magnus, Mildred
K. Cho, and Arthur L. Caplan, “Protecting
Subjects’ Interests in Genetic Research”,
American Journal of Human Genetics, Volume
70, 2002, 965-971
Common Threads
• Intersection of Governments, Civil Society –
Universities, Hospitals, Non Governmental
Organizations, and Businesses in the context of
HUMAN RIGHTS (Non Exploitation, Benefit
Sharing and Fairness)
• Pharmaceutical Research and Clinical Trials
• Genetic Databanks and Databases
• From Bhopal to Doha, health is a business issue
[Sophia Swithern, “From Bhopal to Doha:
Business and the Right to Health”, New Academy
Review, Volume 2, Number 1, Spring 2003]
Common Thread
• Mary Robinson, former United Nations High
Commissioner for Human Rights, quoted in New
Academy Review, Volume 2, Number 1, Spring
2003 by John Morrison, Guest Editor:
• “It’s not a simple case of choosing between
voluntary or regulatory systems to induce
corporate responsibility. If indeed we believe that
universal principles… should become an integral
part of business strategies and day-to-day
operations, regulation alone won’t be sufficient. It
must be coupled with a concerted effort to
stimulate good practices, to be innovative, to give
leadership.”
Government and Governance
• Distinguishable from notions of “government”,
with its focus on the state (and subnational levels
of government): functions of government are to
make law (legislation), implement law (execution)
and interpret law (adjudication)
• Concept of Governance much more expansive,
including influence and input of non-state actors
on the workings of government
• Governance also refers to systems of rules
developed by collectivities (corporations, nongovernmental organizations, and so on)
Aspects of Contemporary Governance
• Private-Public Partnerships, including
Government-University-Industry Research
Relationships (GUIRR) or Research Alliances
(GUIRA)
• Importance and influence of transnational political
institutions, such as World Bank, International
Monetary Fund
• Serious problem of “governance gaps”, in relation
to weak or failing states
Assumptions
• Private Sector Investment can be a driver of
economic growth, development, and poverty
reduction, provided that appropriate regulations
and controls exist
• Markets have internationalized, whilst
governments remain bound by their borders
• Without a robust system of global governance,
gaps arise enabling human rights abuses
Governance Issues
• Calls for multinational enterprises (MNEs),
transnationals (TNEs) and other business entities
to address systemic social problems, such as
global injustice and the needs of people in
developing countries, public health crises (such
as HIV/ AIDS and infectious diseases),
environmental degradation and climate change
• Focus on corporate decision making and impact
of firms on stakeholders
• ETHICAL LEADERSHIP and
• CORPORATE SOCIAL RESPONSIBILITY
Indicators of Ethical Governance
• Global Compact: Introduced by then SecretaryGeneral Kofi Annan in 1999-2000
• Strategic Policy Initiative for Voluntary Corporate
Social Responsibility (CSR)
• Calls on business leaders, trade unions, and nongovernmental organizations to join forces
• Leadership platforms for participants to advance
their commitments to corporate citizenship
• Currently over 7700 corporate participants and
stakeholders from over 130 countries
Goals of Global Compact
• Aim: to involve private companies in tackling
some of the major social and environmental
challenges that arise from increasing globalisation
• Goals: 1. Mainstream the ten Global Compact
principles in business activities around the world
• 2. Catalyze actions in support of broader UN
goals, including the Millennium Development
Goals (MDGs)
• Transparency and Accountability Policy: Annual
Posting of Communication on Progress (COP)
• Failure to communicate can result in delisting
Rationales for Ethical Governance
• Sergio Vieira De Mello (former UN High
Commissioner for Human Rights), “Human
Rights: What Role for Business”, New Academy
Review, Volume 2, Number 1, Spring 2003: UN
Secretary-General was worried about “severe
imbalance in global rule-making: while there are
extensive and enforceable rules for economic
priorities, there are few strong measures” for
other concerns such as human rights, labour, the
environment and anti-corruption, which have such
a direct impact on human welfare
References
• United Nations Development Programme (UNDP)
and Royal Danish Ministry of Foreign Affairs,
Implementing the Global Compact: A Booklet for
Inspiration, 2005
• United Nations Global Compact Website,
“Overview of the UN Global Compact”:
<http://www.unglobalcompact.org/aboutthegc/ind
ex.html>
Global Compact Principles
• Human Rights
• Principle 1: Businesses should support and
respect the protection of internationally
proclaimed human rights; and
• Principle 2: make sure that they are not complicit
in human rights abuses.
Global Compact Principles Continued
• Labour Standards
• Principle 3: Businesses should uphold the
freedom of association and the effective
recognition of the right to collective bargaining;
• Principle 4: the elimination of all forms of forced
and compulsory labour;
• Principle 5: the effective abolition of child labour;
and
• Principle 6: the elimination of discrimination in
respect of employment and occupation.
Global Compact Principles Continued
• Environment
• Principle 7: Businesses should support a
precautionary approach to environmental
challenges;
• Principle 8: undertake initiatives to promote
greater environmental responsibility; and
• Principle 9: encourage the development and
diffusion of environmentally friendly
technologies.
• Anti-Corruption
• Principle 10: Businesses should work against
corruption in all its forms, including extortion and
bribery.
Elements of Global Compact
• 1. Statement of continued support for the Global
Compact by the CEO or other senior executive
• 2. Description of practical actions taken to
implement the Global Compact principles
• 3. Measurement of outcomes or expected
outcomes
CEO Statement Initiative
• STATEMENT: On the occasion of the 60th
anniversary of the Universal Declaration of
Human Rights, we, business leaders from all
corners of the world, call on governments to
implement fully their human rights obligations. We
also reiterate our own commitment to respect and
support human rights within our sphere of
influence. Human rights are universal and are an
important business concern all over the globe.
• 268 CEOs of Companies expressed interest in
signing Statement
Participants in Specific Global Compact
Initiative
•
•
•
•
•
•
•
•
5 Pharmaceutical/ Biotechnology companies
Sanofi/ Aventis, based in France
Novartis, based in Switzerland, participant
Neimeth International Pharmaceuticals, based in
Nigeria
Laboratorios Liomont, based in Mexico
Fundación Salud, Innovación y Sociedad, based
in Spain)
Reference: United Nations Global Compact, CEO
Statement List
<http://64.22.127.124/Issues/human_rights/CEO_
Statement_List.html>
Example of Novartis
• Novartis’ initiative to pay all employees in over 60
countries a “living wage”, as distinct from
“minimum wage”
• Company requested help of Business for Social
Responsibility to develop methodology to
calculate living wages
• Case Study by Jurgen Brokatzky-Geiger, Novartis
Available Online:
• <http://64.22.127.124/system/attachments/716/ori
ginal/E4360C96-351F-4446-8D2D3B5C7B47D5CB.pdf?1262614056>
Millennium Development Goals
• Based on Millennium Declaration, adopted on
September 8, 2000, as formal resolution of the
United Nations General Assembly
• End Poverty and Hunger
• Universal Education
• Gender Equality
• Child Health
• Maternal Health
• Combat HIV/ AIDS
• Environmental Sustainability
• MDG Website:
<http://www.un.org/millenniumgoals/>
Example of HIV/ AIDS
• Target 1:
Have halted by 2015 and begun to reverse the
spread of HIV/AIDS
• Target 2:
Achieve, by 2010, universal access to treatment
for HIV/AIDS for all those who need it
• [Need for treatment still outpaces supply]
• Target 3:
Have halted by 2015 and begun to reverse the
incidence of malaria and other major diseases
Example of Child Health
• Target 1:
Reduce by two thirds, between 1990 and 2015,
the under-five mortality rate
• Progress Unsatisfactory – deaths of children
under five remain unacceptably high (The
Millennium Development Goals Report, 2008):
<http://mdgs.un.org/unsd/mdg/Resources/Static/P
roducts/Progress2008/MDG_Report_2008_En.pd
f>
What Can Be Done?
• (1) Governments DUTY TO PROTECT human
rights of their citizens through appropriate
policies, regulation and adjudication, including
duty to protect against human rights abuses by
non-state actors (including businesses) affecting
persons within their territories or jurisdictions
• (2) Corporate RESPONSIBILITY TO RESPECT
human rights - DO NO HARM
• Companies should exercise DUE DILIGENCE
• (3) Access to Effective Remedies for abuses that
occur, judicial and non-judicial, is crucial
Corporate Due Diligence and
Government Support
• Companies should: Comply with national laws in
host countries
• Adhere to relevant principles of international
human rights instruments (i.e., International Bill of
Rights)
• Manage risks of human rights harms with a view
to avoiding them
• Carry out Human Rights Impact Assessments
• Governments should support and strengthen
market pressures on companies to respect
human rights
Best Practices and Beyond
• Fostering corporate culture that is respectful of
human rights, and development of Best Practices
by committed enterprises
• Measures to prevent involvement or complicity of
companies in human rights violations
• Development of Rights-Complaint Grievance
mechanisms and access to remedies for
breaches
• Government limitations on access to services,
such as trade and investment advice, and export
finance and insurance, to companies
demonstrating compliance with international
human rights norms
References
• Ruggie, John/ Special Representative of the
Secretary-General on the Issue of Human Rights
and Transnational Corporations and Other
Business Enterprises. 2008b. “Protect, Respect
and Remedy: A Framework for Business and
Human Rights”. A/HRC/8/5, April 7, 2008:
• <http://www.reports-and-materials.org/Ruggiereport-7-Apr-2008.pdf>
Universal Declaration of Human Rights
• Article 8, UDHR
• Everyone has the right to an effective remedy by
the competent national tribunals for acts violating
the fundamental rights granted him by the
constitution or by law.
• Article 19, UDHR
• Everyone has the right to freedom of opinion and
expression; this right includes freedom to hold
opinions without interference and to seek, receive
and impart information and ideas through any
media and regardless of frontiers.
UDHR – Right to Health
• Article 25, UDHR
• (1) Everyone has the right to a standard of living
adequate for the health and well-being of himself
and of his family, including food, clothing, housing
and medical care and necessary social services,
and the right to security in the event of
unemployment, sickness, disability, widowhood,
old age or other lack of livelihood in
circumstances beyond his control.
• (2) Motherhood and childhood are entitled to
special care and assistance. All children, whether
born in or out of wedlock, shall enjoy the same
social protection.
UDHR – Sharing in Benefits of
Scientific Advancement
• Article 27, UDHR
• (1) Everyone has the right freely to participate in
the cultural life of the community, to enjoy the arts
and to share in scientific advancement and its
benefits.
• (2) Everyone has the right to the protection of the
moral and material interests resulting from any
scientific, literary or artistic production of which he
is the author.
ICCPR - Privacy
• Article 17, International Covenant on Civil and
Political Rights
• 1. No one shall be subjected to arbitrary or
unlawful interference with his privacy, family,
home or correspondence, nor to unlawful attacks
on his honour and reputation.
• 2. Everyone has the right to the protection of the
law against such interference or attacks.
ICCPR – Participation in Public Life
• Article 25, International Covenant on Civil and Political
Rights
• Every citizen shall have the right and the opportunity,
without any of the distinctions mentioned in article 2 and
without unreasonable restrictions:
• (a) To take part in the conduct of public affairs, directly or
through freely chosen representatives;
• (b) To vote and to be elected at genuine periodic elections
which shall be by universal and equal suffrage and shall be
held by secret ballot, guaranteeing the free expression of
the will of the electors;
• (c) To have access, on general terms of equality, to public
service in his country.
ICESCR – Right to Health
• Article 12, International Covenant on
Economic, Social and Cultural Rights
• 1. The States Parties to the present Covenant
recognize the right of everyone to the enjoyment
of the highest attainable standard of physical and
mental health.
Right to Health Continued
• 2. The steps to be taken by the States Parties to the
present Covenant to achieve the full realization of this right
shall include those necessary for:
• (a) The provision for the reduction of the stillbirth-rate and
of infant mortality and for the healthy development of the
child;
• (b) The improvement of all aspects of environmental and
industrial hygiene;
• (c) The prevention, treatment and control of epidemic,
endemic, occupational and other diseases;
• (d) The creation of conditions which would assure to all
medical service and medical attention in the event of
sickness.
ICESCR – Benefit from Scientific
Progress
• Article 15, International Covenant on
Economic, Social and Cultural Rights
• 1. The States Parties to the present Covenant
recognize the right of everyone:
• (a) To take part in cultural life;
• (b) To enjoy the benefits of scientific progress and
its applications;
• (c) To benefit from the protection of the moral and
material interests resulting from any scientific,
literary or artistic production of which he is the
author.
References
• ICCPR, 1966/ 1976 :
<http://www2.ohchr.org/english/law/ccpr.htm>
• ICESCR, 1966/ 1976:
<http://www2.ohchr.org/english/law/cescr.htm>
• UDHR, adopted and proclaimed December 10,
1948:
• <http://www.un.org/en/documents/udhr/>