Sunday, April 30, 2006

Greatest Hits from CIPIH Recommendations

If you don't have time to read the 228 page report of the WHO's Commission on Intellectual Property, Innnovation and Public Health (oddly named CIPIH), which is on the web here:, you should look over these very useful recommendations. Jamie

page 70
2.10 Countries should provide in their legislation powers to use compulsory licensing, in accordance with the TRIPS agreement, where this power might be useful as one of the means available to promote, inter alia, research that is directly relevant to the specific health problems of developing countries.

page 74
2.12 Public research institutions and universities in developed countries should seriously consider initiatives designed to ensure that access to R&D outputs relevant to the health concerns of developing countries and to products derived therefrom, are facilitated through appropriate licensing policies and practices.

page 95
3.3 WHO should initiate a process to devise mechanisms that ensure the sustainability and effectiveness of public–private partnerships by attracting new donors, both from governments and the private sector, and also to promote wider participation of research institutions from developing countries. However, governments cannot passively rely on what these partnerships could eventually deliver; there is a need for a stronger commitment on their part for an articulated and sustainable effort to address the research gaps identified in this report.

page 106
3.5 Governments should continue to develop forms of advance purchase schemes which may contribute to moving later stage vaccines, medicines and diagnostics as quickly as possible through development to delivery.

page 107
3.6 Recognizing the need for an international mechanism to increase global coordination and funding of medical R&D, the sponsors of the medical R&D treaty proposal should undertake further work to develop these ideas so that governments and policy-makers may make an informed decision.

3.7 Practical initiatives that would motivate more scientists to contribute to this field through “open source” methods should be supported.

page 126
4.5 Policies for biomedical innovation must take account of the fact that health systems in many developing countries remain resource-constrained. Policies must emphasize affordable innovations adapted to the realities of healthcare delivery in developing countries, and covering appropriate technologies for the diagnosis, prevention and treatment of both communicable and noncommunicable diseases. Mechanisms for promoting such adaptive research in a systematic way must be improved.

page 133
4.6 All companies should adopt transparent and consistent pricing policies, and should work towards reducing prices on a more consistent basis for low and lower middle income developing countries. Products, whether originator's or generic, should be priced equitably, not just in sub-Saharan Africa and least developed countries, but also in low and lower middle income countries where there are a vast number of poor patients.

4.7 For noncommunicable diseases, governments and companies should consider how treatments, which are widely available in developed countries, can be made more accessible for patients in developing countries.

4.8 Continuing consideration needs to be given to the prices of treatments for communicable diseases, particularly of second-line drugs for HIV/AIDS treatment.

4.9 Governments of low and middle income countries where there are both rich and poor patients should formulate their funding and price regulation with a view to providing access to poor people.

4.10 Governments need to prioritize health care in their national agendas and, given the leverage to determine prices that patents confer, should adopt measures to promote competition and ensure that pricing of medicines is consistent with their public health policies. Access to drugs cannot depend on the decisions of private companies but is also a government responsibility.

4.11 Corporate donation programmes can be of great value in a number of fields in collaboration with the actions of governments and nongovernmental organizations. However, addressing health needs in developing countries requires more structured and sustainable actions by governments and other parties to stimulate accessibility to products, while generating new treatments and products adapted to the needs of developing countries.

4.12 Governments should remove any tariffs and taxes on health-care products, where appropriate, in the context of policies to enhance access to medicines. They should also monitor carefully the supply and distribution chain to minimize costs that could adversely influence the prices of medicines.

page 139

4.13 The Doha Declaration clarifies the right of governments to use compulsory licensing as a means of resolving tensions that may arise between public health and intellectual property, and to determine the grounds for using it. Developing countries should provide in their legislation for the use of compulsory licensing provisions, consistent with the TRIPS agreement, as one means to facilitate access to cheaper medicines through import or local production.

4.14 Developed countries, and other countries, with manufacturing and export capacity should take the necessary legislative steps to allow compulsory licensing for export consistent with the TRIPS agreement.

4.15 The WTO decision agreed on 30 August 2003, for countries with inadequate manufacturing capacity, has not yet been used by any importing country. Its effectiveness needs to be kept under review and appropriate changes considered to achieve a workable solution, if necessary.

page 140

4.16 Companies should adopt patent and enforcement policies that facilitate greater access to medicines needed in developing countries. In low income countries, they should avoid filing patents, or enforcing them in ways that might inhibit access. Companies are also encouraged to grant voluntary licences in developing countries, where this will facilitate greater access to medicines, in cases where patents do exist on medicines and other products, and to accompany this with technology transfer activities.

4.17 Developing country governments should make available full and reliable information on patents granted. WHO, in cooperation with WIPO and others, should continue to pursue the establishment of a database of information about patents, in order to remove potential barriers to availability and access resulting from uncertainty about the patent status in a country of a given product.

page 141

4.18 Developed countries and the WTO should take action to ensure compliance with the provisions of Article 66.2 of the TRIPS agreement, and to operationalize the transfer of technology for pharmaceutical production in accordance with paragraph 7 of the Doha Declaration on the TRIPS Agreement and Public Health.

page 142
4.19 The restriction of parallel imports by developed countries is likely to be beneficial for affordability in developing countries. Developing countries should retain the possibilities to benefit from differential pricing, and the ability to seek and parallel import lower priced medicines.

4.20 Developing countries need to decide in the light of their own circumstances, what provisions, consistent with the TRIPS agreement, would benefit public health, weighing the positive effects against the negative effects. A public health justification should be required for data protection rules going beyond what is required by the TRIPS agreement. There is unlikely to be such a justification in markets with a limited ability to pay and little innovative capacity. Thus, developing countries should not impose restrictions for the use of or reliance on such data in ways that would exclude fair competition or impede the use of flexibilities built into TRIPS.

page 145
4.21 In bilateral trade negotiations, it is important that governments ensure that ministries of health be properly represented in the negotiation, and that the provisions in the texts respect the principles of the Doha Declaration. Partners should consider carefully any trade-offs they may make in negotiation. Bilateral trade agreements should not seek to incorporate TRIPS-plus protection in ways that may reduce access to medicines in developing countries.

page 146
4.22 Governments and concerned international organizations should promote new purchasing mechanisms to stimulate the supply of affordable new products and to enhance the number of suppliers in order to provide a more competitive environment.

page 147
4.23 Developing countries should adopt or effectively implement competition policies and apply the pro-competitive measures allowed under the TRIPS agreement in order to prevent or remedy anti-competitive practices related to the use of medicinal patents.

page 148
4.24 Countries should provide in national legislation for measures to encourage generic entry on patent expiry, such as the "early working" exception, and more generally policies that support greater competition between generics, whether branded or not, as an effective way to enhance access by improving affordability. Restrictions should not be placed on the use of generic names.

4.25 Developing countries should adopt or effectively implement competition policies in order to prevent or remedy anti-competitive practices related to the use of medicinal patents, including the use of pro-competitive measures available under intellectual property law.

4.26 Bilateral trade agreements should not seek to incorporate TRIPS-plus protection in ways that may reduce access to medicines in developing countries.

page 152
4.27 Governments should take action to avoid barriers to legitimate competition by considering developing guidelines for patent examiners on how properly to implement patentability criteria and, if appropriate, consider changes to national patent legislation.

page 170
5.2 The formation of effective networks, nationally and internationally, between institutions in developing countries and developed countries, both formal and informal, is an important element in building innovative capacity. Developed and developing countries should seek to intensify collaborations which will help build capacity in developing countries.

5.3 WHO, WIPO and other concerned organizations should work together to strengthen education and training on the management of intellectual property in the biomedical field, fully taking into account the needs of recipient countries and their public health policies.

page 174
5.4 Developed countries, and pharmaceutical companies (including generic producers), should take measures to promote the transfer of technology and local production of pharmaceuticals in developing countries, wherever this makes economic sense and promotes the availability, accessibility, affordability and security of supply of needed products.

5.5 Developed countries should comply with their obligations under article 66.2 of the TRIPS Agreement and paragraph 7 of the Doha Declaration.

page 177
5.6 Developing countries need to assign a higher priority to improving the regulation of medical products. Developed countries, and their regulatory institutions, should provide greater financial and technical assistance to help attain the minimum set of regulatory standards needed to ensure that good quality products are available for use. This assistance should also support infrastructure developments within a country, to ensure that good manufacturing practice and supply chain management standards are implemented and sustained.

5.7 The process of the International Conference on Harmonisation currently lacks immediate relevance to the needs of many developing countries, but those countries should maintain their participation in the process. In the meantime, developing country governments and regulatory institutions should give support to regional initiatives, tailored to the current capacities of their member countries, which offer more scope for lifting standards over time, exploiting comparative advantages, avoiding duplication, sharing information and facilities, and promoting appropriate standardization without erecting barriers to competition.

5.8 WHO has an important role to play, in collaboration with interested parties, in helping to strengthen the clinical trials and regulatory infrastructure in developing countries, in particular in sub-Saharan Africa, including the improvement of ethical review standards.

5.9 Apart from the European and Developing Countries Clinical Trial Partnership, donors together with medical research councils, foundations and nongovernmental organizations, need to offer more help to developing countries in strengthening clinical trials and regulatory infrastructure.

page 187
5.10 Digital libraries of traditional medical knowledge should be incorporated into the minimum search documentation lists of patent offices to ensure that the data contained within them will be considered during the processing of patent applications. Holders of the traditional knowledge should play a crucial role in deciding whether such knowledge is included in any databases and should also benefit from any commercial exploitation of the information.

5.11 All countries should consider how best to fulfil the objectives of the Convention on Biological Diversity. This could be, for instance, through the establishment of appropriate national regimes for prospecting for genetic resources and for their subsequent utilization and commercialization; contractual agreements; the disclosure of information in the patent application of the geographical source of genetic resources from which the invention is derived and other means.


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