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Medical Research & Development
Medical Research and Development – Draft 31 July 2009
Importance of Medical R&D
1.Research and the development of new medical technologies and new approaches is necessary to address health needs.
Priority Setting
2.Priority setting in medical R&D is a shared social responsibility [by whom? Everyone?What mechanisms/processes for priority setting should be used? How much are they driven by patient interests, epidemiology, and scientific evidence? Are they national (the source of most regulation) or global?-BB] that should be evidence-based and that should seek to maximize equitable disease prevention and treatment outcomes for all of the world’s populations.
3.Market forces should be regulated and/or complemented to serve social priorities in medical R&D, including research for diseases and conditions primarily affecting so-called neglected diseases.
4.Governments should always have the freedom to determine that a drug or vaccine merits testing, the diseases for which they should be tested, and the populations to be tested, including gender, race, and age.
5.“Innovation” without additional therapeutic benefit can be wasteful and present unnecessary risks and higher costs to patients.
Market failures
Institutions undertaking Medical R&D
6.Involvement of a number of different institutions is essential for the support of medical R&D, including government, intergovernmental, universities and research institutes [Seems important to include the most common players-BB], non-government not-for-profit and for-profit organizations.
Access to Knowledge, the freedom to undertake research and the freedom to innovate
7.Science depends upon access to knowledge. Hoarding and secrecy of data and scientific materials must be discouraged and sharing of data and scientific materials and collaboration in medical R&D must be encouraged.
8.Researchers need timely and affordable access to scholarly journals.
9.National governments should eliminate visa restrictions that limit the ability of students to study at universities in another nation, or restrict the ability of scientists or engineers to participate in conferences or gain experience at firms in another nation [There is a problem of brain-drain in this proposal as formulated - BB].
10.The freedom to undertake research on a commercial or non-commercial basis should not be limited by patents or other intellectual property rights.
11.The freedom to further innovation should not be unduly limited by patents or other intellectual property rights. [This is awfully abstract. It might be helpful to directly mention easily negotiated access to upstream technologies including research platforms/methods. - BB]
12.Patients should freely share biological materials, and consider participation in clinical trials to test new medicines, with the expectation that new scientific advancements will be accessible to all, that clinical trials and other experiments follow appropriate ethical standards, and that the trials are reported to public databases, in order to provide for greater transparency of the scientific evidence, subject to appropriate protections of personal privacy. [I wonder if there shouldn’t be a separate section for clinical trial ethics. If so, there could be discussion of access to resulting innovations, treatment of trial participants, and even perhaps more comparative testing to determine relative therapeutic efficacy. There could also be a reference to post-approval studies and the avoidance of pure marketing studies. - BB]
Funding medical R&D
13.Sustainable sources of finance are needed to support employment in R&D organizations1, equip researchers with the tools necessary to advance science in the field of health, and develop new products and new approaches that improve health outcomes. These systems should enhance and not undermine the goal of access for all for new medical inventions.
14.Governments must ensure that the combinations of direct funding, subsidies and incentives collectively provide for adequate resources for basic, translational and incremental medical research, and the development of new and improved medicines and other technologies in order to address areas of health need and public interest. [It might be appropriate to directly discuss incentives for R&D into pediatric medicines since this is often a neglected area. - BB]
Funding Mechanisms
15.Direct government funding of all stages and phases of medical research will continue to be important.
16.When considering incentives for investments in medical R&D, new approaches are needed to address the many shortcomings of the present system.
17.There should be a greater separation of markets for innovation from the market for the products that incorporate those innovations. When possible and appropriate, the elements of the current systems of stimulating R&D through high prices for medically important products (such as market exclusivity for innovators), should be replaced with new systems that reward developers of new products [You might want to include a footnote clarifying that inventors of research platforms and early-stage inventions should share it these rewards even though you discuss funding such endeavors in para. 18 - BB] directly for improved health care outcomes. This can be most easily be accomplished when systems of public provision or private insurance [Some public funding is not insurance based - BB] exist for medicine, and when it is feasible for expert third parties to evaluate the impact of new medicines on health outcomes.
18.There is also a need to expand methods of funding projects that support open and collaborative research, the development of databases and other research tools, as well as high-risk R&D projects that are likely to be useful for follow-on innovation.
19.Intellectual property rules should not prevent experimental use of inventions or materials [This repeats para. 10 - BB], nor should they discourage or prevent investments in any field of invention [Some fields of technology might be considered against public order - BB].
20.Methods of protecting investments in clinical trials for new medicines, if any, should not prevent governments from registering generic equivalents and making medicines available at affordable prices or require unethical or unnecessary replication of human experiments.
Recognition
21.Individuals and communities that collaborate in scientific research should receive appropriate recognition for contributions to new scientific discoveries [ Who provides this recognition and does it include compensation or reward? - BB].
Competition
22.Actual and/or potential competition to manufacture and supply medicines, vaccines and other medical technologies at efficient economies of scale is important to protect society from pricing abuses, and to ensure adequate, affordable and equitable supplies of medical products.
Registration
[Registration logjams now approach the severity of IP logjams in terms of access to medicines - BB]
23.Medical products should be made promptly available in all countries, large and small, rich and poor, and thus incentives and more efficient procedures for follow-on registration by innovators and generic producers must be promoted.
Transfer of Technology to Developing Countries
24.The capacity to manufacturer medicines, vaccines and other medical technologies should be promoted in developing countries through licensing, direct technology transfer and other measures.
Transparency, and objective evidence
25.Prices, sales, and R&D costs should be transparent.
26.Testing of products should be transparent, and funded by sources that do not have incentives to distort or misrepresent findings, and which address the most useful scientific and medical questions. [If there is a new section on clinical trials/testing, this paragraph could go in that. - BB]
27.The results from clinical trials should be published in public registries.
New Global Frameworks for Medical R&D
28.Governments must support global agreements to share in the costs of developing and evaluating new medicines.
Draft of July 17, 2006
1.Research and development is a necessary and valued component of the health care system.
2.A number of different institutions are essential for the support of medical R&D, including government, intergovernmental, non-government not-for-profit and for-profit organizations.
3.The systems for supporting research and development of new drugs should ensure sustainable sources of finance that support employment in R&D organizations, but also should not undermine the goal of access for all for new medical inventions. [TF: I'm not sure why we should be "supporting employment in R&D organizations." Suppose, for instance, that we concluded that malaria research could be conducted more effectively and efficiently by university labs than by private drug companies. Should we be troubled by the fact that, shifting funding from the latter to the former would put some research scientists out of work?]
4.Systems for stimulating R&D should address areas of greatest health need and public interest. [TF*: When does "the public interest" diverge from the "areas of greatest health need"? Perhaps when pursuit of a pure utilitarian criterion would neglect the victims of rare diseases (the orphan drug problem)? If that's the only circumstance, I suggest that we spell it out. Are there others?]
5.Separation of markets for innovation and products that incorporate those innovations. When possible and appropriate, the elements of the current systems of stimulating R&D through high prices for [essential] medical products (through such measures as market exclusivity for innovators), should be replaced with new systems that reward developers of new products directly for improved health care outcomes. This can be easily accomplished when systems of public or private insurance exist for medicine, and when it is feasible to estimate the impact of new medicines on health outcomes.
6.There is also a need to expand methods of funding projects that support open research, the development of databases and other research tools, as well as high-risk R&D projects that are likely to be useful for follow-on innovation.
7.Science depends upon access to knowledge. Hoarding of data and materials must be discouraged.
8.Intellectual property rules should not prevent experimental use of inventions or materials, nor should they discourage or prevent investments in any field of invention.
9.National governments should eliminate visa restrictions that limit the ability of students to study at universities in another nation, or restrict the ability of scientists or engineers to participate in conferences or gain experience at firms in another nation.
10.Methods of protecting investments in clinical trials for new medicines should not prevent governments from making medicines available at affordable prices or require unethical or unnecessary replication of human experiments.
11.Individuals and communities that collaborate in scientific research should receive appropriate recognition for contributions to new scientific discoveries.
12.Governments must support global agreements to share in the costs of evaluating new medicines. Such testing should be transparent, and funded by sources that do not have incentives to distort or misrepresent findings, and which address the most useful scientific and medical questions. [TF: Could we add that governments should assert and exercise the power to select the drugs that merit testing and the diseases for which they should be tested? The purpose of such a provision would be to avoid outrages like that discussed in The Guardian today, in which the British version of the FDA is powerless to determine whether small doses of Avastin are effective in dealing with a common source of blindness, because the maker and patent holder (Genentech) refuses to apply for a license to use Avastin on blindness. Why? Because Genentech hopes to make much more money by licensing a closely related drug, Lucentis, for blindness.]
13.Patients should freely share biological materials, and consider participation in clinical trials to test new medicines, with the expectation that new scientific advancements will be accessible to all, that clinical trials and other experiments follow appropriate ethical standards, and that the trials are reported to public databases, in order to provide for greater transparency of the scientific evidence, subject to appropriate protections of personal privacy.
*TF is Terry Fisher.
1.Research and the development of new medical technologies and new approaches is necessary to address health needs.
Priority Setting
2.Priority setting in medical R&D is a shared social responsibility [by whom? Everyone?What mechanisms/processes for priority setting should be used? How much are they driven by patient interests, epidemiology, and scientific evidence? Are they national (the source of most regulation) or global?-BB] that should be evidence-based and that should seek to maximize equitable disease prevention and treatment outcomes for all of the world’s populations.
3.Market forces should be regulated and/or complemented to serve social priorities in medical R&D, including research for diseases and conditions primarily affecting so-called neglected diseases.
4.Governments should always have the freedom to determine that a drug or vaccine merits testing, the diseases for which they should be tested, and the populations to be tested, including gender, race, and age.
5.“Innovation” without additional therapeutic benefit can be wasteful and present unnecessary risks and higher costs to patients.
Market failures
Institutions undertaking Medical R&D
6.Involvement of a number of different institutions is essential for the support of medical R&D, including government, intergovernmental, universities and research institutes [Seems important to include the most common players-BB], non-government not-for-profit and for-profit organizations.
Access to Knowledge, the freedom to undertake research and the freedom to innovate
7.Science depends upon access to knowledge. Hoarding and secrecy of data and scientific materials must be discouraged and sharing of data and scientific materials and collaboration in medical R&D must be encouraged.
8.Researchers need timely and affordable access to scholarly journals.
9.National governments should eliminate visa restrictions that limit the ability of students to study at universities in another nation, or restrict the ability of scientists or engineers to participate in conferences or gain experience at firms in another nation [There is a problem of brain-drain in this proposal as formulated - BB].
10.The freedom to undertake research on a commercial or non-commercial basis should not be limited by patents or other intellectual property rights.
11.The freedom to further innovation should not be unduly limited by patents or other intellectual property rights. [This is awfully abstract. It might be helpful to directly mention easily negotiated access to upstream technologies including research platforms/methods. - BB]
12.Patients should freely share biological materials, and consider participation in clinical trials to test new medicines, with the expectation that new scientific advancements will be accessible to all, that clinical trials and other experiments follow appropriate ethical standards, and that the trials are reported to public databases, in order to provide for greater transparency of the scientific evidence, subject to appropriate protections of personal privacy. [I wonder if there shouldn’t be a separate section for clinical trial ethics. If so, there could be discussion of access to resulting innovations, treatment of trial participants, and even perhaps more comparative testing to determine relative therapeutic efficacy. There could also be a reference to post-approval studies and the avoidance of pure marketing studies. - BB]
Funding medical R&D
13.Sustainable sources of finance are needed to support employment in R&D organizations1, equip researchers with the tools necessary to advance science in the field of health, and develop new products and new approaches that improve health outcomes. These systems should enhance and not undermine the goal of access for all for new medical inventions.
14.Governments must ensure that the combinations of direct funding, subsidies and incentives collectively provide for adequate resources for basic, translational and incremental medical research, and the development of new and improved medicines and other technologies in order to address areas of health need and public interest. [It might be appropriate to directly discuss incentives for R&D into pediatric medicines since this is often a neglected area. - BB]
Funding Mechanisms
15.Direct government funding of all stages and phases of medical research will continue to be important.
16.When considering incentives for investments in medical R&D, new approaches are needed to address the many shortcomings of the present system.
17.There should be a greater separation of markets for innovation from the market for the products that incorporate those innovations. When possible and appropriate, the elements of the current systems of stimulating R&D through high prices for medically important products (such as market exclusivity for innovators), should be replaced with new systems that reward developers of new products [You might want to include a footnote clarifying that inventors of research platforms and early-stage inventions should share it these rewards even though you discuss funding such endeavors in para. 18 - BB] directly for improved health care outcomes. This can be most easily be accomplished when systems of public provision or private insurance [Some public funding is not insurance based - BB] exist for medicine, and when it is feasible for expert third parties to evaluate the impact of new medicines on health outcomes.
18.There is also a need to expand methods of funding projects that support open and collaborative research, the development of databases and other research tools, as well as high-risk R&D projects that are likely to be useful for follow-on innovation.
19.Intellectual property rules should not prevent experimental use of inventions or materials [This repeats para. 10 - BB], nor should they discourage or prevent investments in any field of invention [Some fields of technology might be considered against public order - BB].
20.Methods of protecting investments in clinical trials for new medicines, if any, should not prevent governments from registering generic equivalents and making medicines available at affordable prices or require unethical or unnecessary replication of human experiments.
Recognition
21.Individuals and communities that collaborate in scientific research should receive appropriate recognition for contributions to new scientific discoveries [ Who provides this recognition and does it include compensation or reward? - BB].
Competition
22.Actual and/or potential competition to manufacture and supply medicines, vaccines and other medical technologies at efficient economies of scale is important to protect society from pricing abuses, and to ensure adequate, affordable and equitable supplies of medical products.
Registration [Registration logjams now approach the severity of IP logjams in terms of access to medicines - BB]
23.Medical products should be made promptly available in all countries, large and small, rich and poor, and thus incentives and more efficient procedures for follow-on registration by innovators and generic producers must be promoted.
Transfer of Technology to Developing Countries
24.The capacity to manufacturer medicines, vaccines and other medical technologies should be promoted in developing countries through licensing, direct technology transfer and other measures.
Transparency, and objective evidence
25.Prices, sales, and R&D costs should be transparent.
26.Testing of products should be transparent, and funded by sources that do not have incentives to distort or misrepresent findings, and which address the most useful scientific and medical questions. [If there is a new section on clinical trials/testing, this paragraph could go in that. - BB]
27.The results from clinical trials should be published in public registries.
New Global Frameworks for Medical R&D
28.Governments must support global agreements to share in the costs of developing and evaluating new medicines.
