Proceedings
DAY 1.
- Thank you everyone for coming
- Thanks for OSI's generous support to convening this meeting
- Format for the meeting:
1. 10 minute presentations
Discussion will be facilitated by commentators listed: maximally interactive
Networking breaks and meals
- Goals of the meeting:
1.Get an understanding of the the field of health law, policy, and research
2.Identify priorities for future funding
3.Create leads for partnership and collaboration to work on high-priority issues
- OSI work includes funding of projects addressing needs of marginal populations
- Needle exchange programs
- Substitution therapy
- Mental health work
- Sex workers
- End of life care
- Monitoring and Governance
- Look at the law on the books vs. the implementation of law
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Are commitments being translated into policy?
- Promotion of Civil Society
- Not only NGO's
- Includes organizations such as universities and media
- Interfacing with governments, and questions of governance
- Networked programs
- Global programs, i.e. Justice Initiative
- Media programs, making sure issues are communicated accurately
- Entry points into China, OSI's interests
- Health law
- HIV/AIDS (issues OSI has addressed in the past)
- China has more open Needle Exchanges and methadone policies now
- Professionalism
- medical profession faces complex challenges
- Seeing professionalism as a counter to capitalization of health economy
- Rapidly growing population, with geographic and economic shifts changing health care
- Haphazard health reform, that has left entire regions and sectors of society behind
- Supposedly free public hospitals are never actually free of charge
- Money buys the best care
- Medical costs have seriously increased while government spending declined
- China is more than self-sufficient in its resources and drugs
- Problem in the flow of physicians
- Not evenly distributed and reaching the poor areas
- Regulating institutions is messy due to the complicated governmental system
- Three stages of reform
- Early stage
- Reform / Transmission stage
- Continued reform
- Reasons for Reform
- Try to separate law enforcement functions from general public health functions
- Combine material health care with disease prevention
- Combine academic/research work with public health work
- Challenges
- Public health is separated from medical care
- How to combine the system down to the villages
- How to handle disease outbreaks
- Need to integrate public health and health care
- Focus on restructuring the Ministry of Health
- Need help in governance to integrate national, regional, local health functions
- Problem: no clear definition of how to address some of the main problems
- What should be done with public hospitals in urban areas?
- Transform them into corporate form?
- Solutions need to be grounded in the dynamics of the country
- Reconcile funding flows from Ministries of Health and Labor
- They are also very limited in human resource skill - too few doctors in rural areas
- Modernization of Public Health
- Need to redesign the system to address non-communicable diseases
- Some countries changed the process by renaming the system (i.e. to CDC)
- This made it worse by taking away inspections and making them dependent on government funding
- Regulation doesn’t work without money, role of funding is crucial in reforming system
- Is self-regulation even appropriate in China, a statist country?
- How do you create a space for professionals to regulate their activity that’s not in the state’s realm?
- Work force
- What is the mandated education/training of health care providers?
- What kind of providers are necessary?
- Experience in developing/presenting health law (B. Safriet)
- Build bridges between people and professions
- Goal has to be to simplify presentation
- Acknowledge ambiguity
- Explain norms and habits of the profession
- Emphasize that there’s discretion at every level
- Have interdisciplinary education (i.e. law schools and med schools)
- Textbook - organized by policies and regulations of the Ministry of Health
- Introduction is the legal structure of China
- Public health law
- communicable disease control, food hygiene, emergency requirements
- Medical care law
- relationship between professionals and patients, health products law, etc
- Medical ethics
- Working with Scott Burris on training program for Chinese public health professionals
- Professionals often felt rushed to judge and act in emergencies
- There is a need for:
- basic education
- a process for decision making with common ethical issues
- duty to protect others v. confidentiality v. institutional pressures
- Training curriculum
- Includes cases of public health situations and programs
- There is limited utility in didactic lecture
- Programs must be integrated and situational
- The training in China received a positive reception
- Four areas of work
- Gender/governance
- Family planning
- Health system reform
- Improving AIDS response in China
- Train government officials towards effective governance for HIV/AIDS response
- Important role of civil society (NGO's, communities, etc.)
- Eight modules
- For example, HIV and human rights, gender and HIV, comprehensive prevention, strategic planning and leadership for the government
- Align authority in local and national government
- Local governments often don’t implement national government rules
- Inability of doctors to coordinate - need management skill and experience in leadership
- reorganize
- deregulation and fiscal market forces drive inequalities
- reevaluate the education of public health leadership and human resources
- Comments
- Training and policy must recognize that financing sources lead to inefficient policy
- Beijing’s law efficiency is dubious, partly due to issues of authority
- But, AIDS programs were done successfully nationally with national funds, so it can be done if the impetus is there
- There is decentralized power generally but the central apparatus is still stronger
- Where is the motivation in AIDS control, what are the drivers?
- There is a demand for health law education among health care workers
- Set up courses
- People in China are more trained in contracts, international law, business law, IP law
- Where are public health lawyers working and what are they doing?
- We have assumptions and the American experience
- We assume health lawyers and regulators are needed
- Need people who want to teach these courses
- Idea is versatility and breadth of understanding
- Classroom context does not always translate well into real life experience
- Need to bring case-based learning as per training designed with John Anderson
- Works on ethical issues of conducting biomedical research in the 3rd world
- Example
- It was unethical to compare buprenorphine/naloxone + counseling v. counseling alone
- Subjects were from marginalized groups (HIV+, IDU, rural, etc.)
- Ethical standards: regulation v aspiration
- Does this make sense in China? Would informed consent work?
- Issues
- Role of host-country stakeholders in research
- Do these people really understand the nature of the research?
- Role of government policy
- Clinical research can be a leverage point for other issues
- Regulatory structure of human subjects research
- There are regulations from Ministry of Health
- China also subscribes to International Guidelines
- Acknowledges IRB's and informed consent, but little actual understanding
- Funding
- CDC, Gates, etc. funds trials for diseases at the top of the public health agenda
- There is a push to do clinical trials for multinational drugs
- raises issue a/b participants and communities - do they even benefit?
- Does it just end up in other nations and/or to the rich?
- Media plays a role, especially when they are uneducated
- IRB's
- How can we claim we have the answer when our system is not perfect?
- Her experience during the SARS outbreak as a doctor
- The disease was serious by April of 2003
- It was commonly referred to as atypical pneumonia
- The hospital was built specially for SARS patients in seven days
- Treatment was combination:
- antiviral, anti-infectious, etc.
- Doctors were not required to report before March of 2003
- Surveillance systems have improved: now there is on-line reporting
- Disconnect between military vs. civilian health systems:
- doctors inside military are not subjects to same reporting requirements
- Have worked with Temple to develop a research and teaching portfolio on health law
- Is undertaking a number of studies and legal drafting projects
- Procedural requirement for law drafting
- First draft, then submit draft to state consul who circulates it to the different ministers, then standing committee
- Process recently changed due to pressure for public hearing procedures
- One of the studies is in laws related to organ donation
- No current clear legal definition of brain death in China
- Different cultural conceptions must be addressed in order to improve medical systems related to transplant and organ donation programs
- There is a policy section in the Bureau responsible for the 1st draft of laws. Then a consultation in the Ministry of Health. Then the 2nd draft is circulated to ministers, then the standing committee. There is a move towards more public notice and hearings, like in the US.
- Law on the books vs. law in practice
- Shortage of experience, need for case based education
- Very little psychological and biomedical training in China
- Proxies for vulnerable clinical consent
- It is a balance - How much discretion do you grant to someone you entrust to make a decision for you?
- Reporting on the Internet disease case
- Is it anonymous? Are there protections for reporters who are penalized by superiors?
- China has a history of mandatory reporting on the books, but vertical integration and institutional (reward/punishment) structures have rendered it dysfunctional
DAY 2
- Constructed models of government response, comparing SARS with AIDS
- Process of Agenda Setting
- Institutional Context, Problem/Political Window, Policy Window, Agenda Setting and Decision Making
- Objective: examine critical process of HIV reform
- Authority plays a role
- Lack of administration allows HIV/AIDS to develop nationwide
- Two types of infectious disease
- Outbreak, i.e. SARS
- Attrition, i.e. HIV/AIDS
- This difference explains why SARS was handled better
- SARS opened the problem/political window by exposing the problems of the health system and government development agenda
- Then the policy window was opened
- Implication: political institutional context, nature of disease, and other events should be taken into account
- Health system reform
- Has been unsuccessful in China
- Attribute it to health policy failure
- Emphasize problems of marketalization, commercialization
- Political logic of health system change in post-Mao China
- Structure was a rigid hierarchy with power in Mao and his personal preferences
- With his death there was a crisis with three consequences
- government intervention in health policy became very rare
- shifted locale of health policy making to the neutral administration zone
- fiscal and bureaucratic decentralization
- diffusion of health and political resources
- Comment
- SARS impacted the commercial sector which is why the government reacted
- Would it have been different if SARS first affected marginalized populations?
- Have done extensive field research with grass-roots NGO activities in China
- Chinese social groups in AIDS prevention
- NGO's or NGO's to be
- Organizations led by people
- There are Chinese citizen social groups that started with other focuses but now devote at least some resources to AIDS prevention
- Rural community based volunteer groups and religion-based groups
- Local CDC and hospital sponsored AIDS care centers
- International non-state actors in AIDS prevention in China
- not all are specific AIDS organizations
- Help develop training materials
- Comments
- How effective are external NGO efforts to support civil society in China?
- always limitations, but there are stronger partnerships and networks now
- How strong are the NGO's themselves?
- private funding is increasing in the AIDS field with more foundations coming in
- There are also a variety of organizations, some more progressive than others
- Are the stringent laws significant barriers?
- Yes, but environmentalists have found a way to maneuver around
- In AIDS cases, health is different
- Government has centralized external access to local health systems
- Emerging infections are a threat to the Chinese business community
- part of their business plans should be the ability for the public health structure to response to the next PH emergency
- agenda becomes how to work with those interests to show it is in your business models’ advantage to have some kind of public health system that can respond
- Make an alliance with the commercial explosion for a conference in 2006
- Implementation and enforcement in using law to improve quality of care
- Use law to encourage professionalism, peer review, self-reg, voluntary hosp accreditation
- Need for research to effectively develop systems of professionalism, peer review, self-regulation
- Medical liability is another way to use law to improve quality of care
- 2002 regulation on handling medical accidents by state counsel
- replaced previous regulations
- system of compensation for injured patients
- also a system of quality assurance, mandatory reporting, administrative supervision, regulatory role of departments of health, administrative discipline
- similar to the current trend in US - combining reform of liability system with efforts to improve quality of care
- More on the 2002 regulation - how it fits into the Chinese health care system
- Many think enterprise liability is the best way to improve quality of care
- China is in a better position than US to implement enterprise liability since they already recognize organizational liability
- The reform is not needed legally, but in the structure of the health care system
- Enterprise liability in US is premised on idea that the organization can improve quality of care
- But people, i.e. the president, of hospitals in China have little power to improve quality
- but also in China, the doctors are employees. They don’t need to deal with the legal issues like the US - i.e., is the doctor really an employee, ostensible agent, etc
- We should give people that run health care institutions incentives, flexibility and authority to improve the quality of care
- Privatization
- Issue is whether some hospitals in some circumstances should be subject to regulated privatization while others continue to be owned/operated by the government?
- The gov is already allowing some privatization to go on, but it is happening in a very haphazard way
- It’s not being done deliberately or in a regulated manner
- Comments
- How do you set up an experiment to see if defensive medicine exists?
- That’s not a big concern
- We think of increase in liability insurance or impact on medical costs, but in China, the crisis is the lack of a credible system
- Malpractice is important in China - patients don’t really have anywhere to go
- In China, there is no real system of credible dispute resolution
- They use technical authentication
- There’s a need for a more realistic system that people can have confidence in
- There’s been incidents of violence against doctors
- Privatization: he’s talking about public gov hospitals turning into private for-profit hospitals, not non-profit NGO hospitals
- Managerial people in hospitals: people do not have power to hire/fire doctors
- They don’t have anywhere near the amount of power people have in other countries
- Is it like two different countries/political systems in some way - rural v. urban
- Hopes to be able to do the following:
- To be able to offer on-line courses to Chinese lawyers, mental health professors, advocates.
- Continue/expand advocacy networking that has been going on in Japan/Taiwan
- Train lawyers in China to deal with mental health law
- Work with Chinese law professors to deal with mental health and related subject matters
- Research suggests that these courses and advocacy networking will be important in China
- Appear to be very few lawyers able to represent those with mental illness
- Unclear if mental disability law even exists in China
- Mental illness is still sometimes blamed on evil spirits, God, etc
- Health law is currently not taught in most law schools
- There are no Pan-Asian advocacy networks in this area
- Comment: there was one law school in China working on disability law with UNICEF a few years ago
- Psychotropic drugs being brought in
- People need access to certain drugs
- But in some places, as the drug market opens up, other services that would normally be provided fade away
- Wants to look at risk factors related to cancer
- Lack of preventive services, guidelines, recommendations, regulations for early detection
- STD - HPV testing
- Strictly a behavior problem, like AIDS, that will be leading to cervical cancer
- Problems with access to health care service
- No insurance, no base for future health care - especially women who may retire at the age of 40-45
- If they don’t have money available upfront, they will not be treated
- Former FDA lawyer, now advising drug-related IP activities in China
- US v China generally
- China has 1.4% of the world’s drug market - expected to be 5th largest in world by 2010
- US has 45% of world drug market and expected to remain so for many years to come
- US has much less original applications filed (2004) and many less PhRMA members
- China
- China’s Food/Drug Administration is organized by the US system
-
Until 2003, it was only the state drug administration with no food component
- Statute: drug administration law
-
There’s more than 200 secondary regulations, provincial regulations
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National government preemption: approval of new drugs
- Types of approval: new drugs and imported drugs
- New drugs: clinical trial - safety and efficacy
- Imported drugs: registration, 5-yr renewal
- Advertising
- Pre-approval of ads by provincial FDAs
- Enforcement
- Unapproved, unregistered drugs, counterfeit, inferior quality drugs
- Warning, seizure, jail, etc
- US
- FDA, Food Drug Cosmetic Act, regulations (CFR)
- New drug application - non-patent exclusivity (unique to US)
- Comments
- Is there any way China would exercise permission from WTO to manufacture off-patent AIDS drugs for local use for their program?
- Intersection of commerce and health issues
- Compulsory licensing
- Why are drugs so expensive, why is so much money spent on drugs?
- The manufacturers in China are joint ventures
- Lot of the cost is incurred by hospitals
- Did hospitals make more profit on these expensive drugs? How does hospital end up if they prescribe less expensive, generic drugs
- Essential drugs are reimbursed
- Hospitals and doctors try to tell patients that drugs are not on that list
- There is no substitution like in US
- Role of trademark in pharmaceutical issue
- millenniumproject.org
- Recommendations on how to improve access to essential drugs
- Advertising issue
- Here, we have agencies looking at false/misleading advertising
- China has a similar system, maybe better
- Labeling and ads have to be pre-approved
- TRIPS Process
- Legal for compulsory license for PH emergencies - never been used
- On-going projects
- China health surveillance system
- Health, socioeconomic consequences of health
- MEDICAID pilot project
- Establish med safety net for urban poor
- Role of Private Sector
- 5-country case study
- Looks at comparative performance of public v private providers
- Regulatory and other constraints
- Linking Health and Econ Development
- Gather information at county-household level to provide a model on health and wealth
- Suppose health is an important investment in economic growth - how can you coordinate a policy
- HSPH China Initiative
- Study health, health system problems
- Have reg dialog with policy makers
- Train health leaders
- Programs, forums, training - see slide presentation for details
- Training - 2 classes over 5 years
- One class of senior national provincial policy makers
- Another of health care executives
- Progress
- Dean Bloom approached for help
- HSPH proposal approved by Provost in January 2005
- Influencing policy: an example (Health insurance for 800 million Chinese)
- Research -> policy -> demonstration
- Medical expenses are the #1 poverty generator in China
- CMS (Cooperative Medical System)
- Financing by welfare fund
- Delivery: 3 tier system
- Outcomes
- 90% of pop had access to prevention, basic services
- Rural Health Security Study
- Scope: major problems and why no insurance; policy recommendations
- Dissemination: international seminar -> briefing papers -> publication
- Outcome: Policy Development
- President developed the new rural health policy
- Lessons
- Getting their attention: it’s the poverty!
- Leaders have two interests: poverty reduction and political stability
- Give them a chance: timely and timed information dissemination
- Politicians: when confronted with bad news, they want to be prepared to say two things
- I’m not surprised, I knew this problem
- These are things I’m going to do to address these problems
- Comments
- Problem is still the local gov and policy implementation
- Still have to focus on economic growth; GDP is key to political success
- Capacity building, incentives, pressure - the CIP model
- All 3 have to be in place to move people
- Matching fund model
- Given the decentralized system, you can promote/persuade them to move
- But without binding contract, they’re not going to do it
- Central government gives money but it has to be matched by different levels of local government, which then has to be matched by the household
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- Effective, fair, just regulation - very broad
- From normative regulation like professionalism to rules for malpractice
- What will be required to make health law an officially recognized field of study
- . what materials are being used?
- What about the Safriet/Wang curriculum
- Will need to develop materials and urge more scholarship
- Journal and dissemination of other materials to medical and law schools
- Teaching initiatives
- legal clinics - move into a more policy-like role
- promoting more courses and new courses
- Health care quality initiatives, like malpractice reform, governance/institutional reform, and promotion of standardization
- Advocacy development
- trying to link non-business and business NGOs
- Micro-governance interventions
- How do you get them to scale? How to implement lessons learned?
- NGO law as a barrier - too many requirements (i.e. establishment, fundraising)
- Follow-up
- Should there be a broader set of actors involved? Help us expand this network
- Might be interesting to use a list-serv to exchange materials and ask questions
- Assumption of the slides: health law is important and necessary in China
- Is there another model we can develop that addresses this question: can we help people understand the need for health law
- workshop: business, service providers, community groups who may not know about legal system or access to health lawyers
- China has organized networks, more structured than US
- Working at awareness of HL issues is a good starting point
- Also use the media
- Health law clinics
- Are there are other platforms to discuss issues
- Link NGO and activists in certain areas -> then put them in touch with legal experts
- bring concrete problems into the forum
- are law clinics the right approach? Should investigate Ford's experience
- do other platforms exist in China?
- Access, finance, license, etc - many different domains
- separating them can help us reach more people
- expand/categorize subdivisions of health law
- you can also explain how problem fit under the umbrella of health law, which encourages understanding
- Among law professors - there are so many different subdivisions
- Mental disability law v health law
- There will be people that will find this interesting who had no idea the issue existed
- So what about a mass mailing to other professors who will be interested, who may have worked in China, etc
- Subset of people, i.e. China lawyers and specialists
- These people will have great understanding, knowledge, and connections
- Will be worthwhile to identify them, ie Stanley Lubman
- Program development for Temple collaboration with Policy Program at Harvard
- 3 pillar model
- Mutually reinforcing research, training, and policy
- Identify your target audience and prioritize the audience
- Simultaneously target three groups
- legal experts in public health law
- policy makers (health policy regulators and legislators)
-Yuanli Liu can be helpful here
- general public - social advocacy
- Developing a program for legislators?
- Organize a conference in China
- Effective organizational mechanism to get people working on the issue
- Next year: international medical ethics Congress meeting in China
- That can be an opportunity for collaboration (ethics and law)
- if yes, then get started on this right away
- By International Bioethics Society in Beijing, 8/2006
- Commercial activities
- Using Joan’s model
- Emergency events are going to continue to occur
- There is an understanding of the preparedness steps in the model
- Then the politics of the situation are practical
- There will be a moment after emergencies where law/policy changes
- prepare for this change
- need to have agendas thought through
- selling it to business
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