Global Health Watch 1 in one file
Global Health Watch 1 in one file Global Health Watch 1 in one file
Health care systems | B2 for the annulment of all TRIPS-plus agreements and policies related to medicines in bilateral and regional trade agreements. In the interim, NGOs and health agencies must work with governments to make maximum use of the existing TRIPS flexibilities. Countries exempt from being TRIPS-compliant until 2016 must not be pressurized into introducing new patent laws before then, or enacting new laws that undermine their capacity to make use of the flexibilities, as some are doing. Governments have a better chance of withstanding pressure from Big Pharma and the political establishments of the US and EU with public support and civil society involvement. Efforts are also required to develop governments’ technical and legislative capacity. Keeping the generic supply pipeline open The generic medicine manufacturing capacity in countries such as India, China, Brazil and Thailand must be maintained. The application of the TRIPS flexibilities is one important mechanism. Continued support must be given to WHO’s efforts in pre-qualifying quality products and producers so as to speed up the process by which generic medicines can be registered for use in countries. So far, the WHO system has proved effective and efficient. The administrative and paperwork requirements for the TRIPS compulsory licensing flexibilities should also be streamlined, particularly in cases where the response to public health emergencies can be strengthened by rapidly increasing access to generic medicines. WHO could be funded to provide advice and assistance to countries needing to use the flexibilities. A new paradigm for funding and stimulating pharmaceutical R&D New ways to fund and stimulate pharmaceutical R&D are needed to achieve the goal of universal access to essential medicines and avoid the huge inefficiencies and corruption of the current system. Four innovative proposals could stimulate R&D while reducing the difference between the sales price and actual cost of production (Baker 2004b). These are: • a mandatory employer-based research fee to be distributed through intermediaries to researchers; • zero-cost compulsory licensing patents, in which the patent-holder is compensated based on the rated quality of life improvement generated by the drug, and the extent of its use; • an auction system in which the government purchases most drug patents and places them in the public domain; and 114
• financing pharmaceutical research through a set of competing, publicly supported research centres. These proposals could remove the need for excessive spending on marketing, provide adequate financing for expensive biomedical research, reduce incentives for wasteful copycat research and for data protection and scientific secrecy, minimize the risk of political interference in setting research priorities, and be administratively feasible at the international level. A proposed Medical Research and Development Treaty, which proposes a new paradigm that includes minimum national obligations for supporting medical R&D, with flexibility regarding the business models and intellectual property rules, should be supported (http://www.cptech.org/workingdrafts/ rndtreaty.html, accessed 8 March 2005). More directly, the Drugs for Neglected Diseases Initiative (http://www.dndi. org, accessed 8 March 2005) aims to raise financing directly to build a balanced research portfolio of long, medium and short-term projects to fill identifiable gaps in the drug development pipeline for key neglected diseases. Strengthen the transparent and ethical regulation of pharmaceutical companies Profit-motivated pharmaceutical companies, whether Big Pharma or generic manufacturers, cannot be left to operate without a strong regulatory framework to promote rational medicine use and patient safety. The erosion of independent national and international regulatory structures and powers must be reversed. Civil society must play a further watchdog role that holds pharmaceutical companies and government regulators accountable to high standards of ethical practice. WHO, working in collaboration with NGOs such as Health Action International and Public Citizen, should produce a periodic scorecard of the competence and probity of national medicine regulatory bodies as a mechanism for monitoring progress. Laws, policies and agreements should be established to make the full disclosure of all clinical trials data an obligation. Failing this, any breaches of patient safety arising from the deliberate disclosure of clinical trials data should be treated as criminal acts and be prosecuted. Legitimize price control options Domestic regulations to control drug prices are an important mechanism to promote access. In countries where public expenditure on health care is relatively high, government- or publicfunded health insurance can keep medicine costs low by negotiating cheaper prices with pharmaceutical manufacturers. In countries where public health Medicines 115
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<strong>Health</strong> care systems | B2<br />
for the annulment of all TRIPS-plus agreements and policies related to medic<strong>in</strong>es<br />
<strong>in</strong> bilateral and regional trade agreements.<br />
In the <strong>in</strong>terim, NGOs and health agencies must work with governments<br />
to make maximum use of the exist<strong>in</strong>g TRIPS flexibilities. Countries exempt<br />
from be<strong>in</strong>g TRIPS-compliant until 2016 must not be pressurized <strong>in</strong>to <strong>in</strong>troduc<strong>in</strong>g<br />
new patent laws before then, or enact<strong>in</strong>g new laws that underm<strong>in</strong>e<br />
their capacity to make use of the flexibilities, as some are do<strong>in</strong>g. Governments<br />
have a better chance of withstand<strong>in</strong>g pressure from Big Pharma and the political<br />
establishments of the US and EU with public support and civil society<br />
<strong>in</strong>volvement. Efforts are also required to develop governments’ technical and<br />
legislative capacity.<br />
Keep<strong>in</strong>g the generic supply pipel<strong>in</strong>e open The generic medic<strong>in</strong>e manufactur<strong>in</strong>g<br />
capacity <strong>in</strong> countries such as India, Ch<strong>in</strong>a, Brazil and Thailand must be<br />
ma<strong>in</strong>ta<strong>in</strong>ed. The application of the TRIPS flexibilities is <strong>one</strong> important mechanism.<br />
Cont<strong>in</strong>ued support must be given to WHO’s efforts <strong>in</strong> pre-qualify<strong>in</strong>g<br />
quality products and producers so as to speed up the process by which generic<br />
medic<strong>in</strong>es can be registered for use <strong>in</strong> countries. So far, the WHO system has<br />
proved effective and efficient.<br />
The adm<strong>in</strong>istrative and paperwork requirements for the TRIPS compulsory<br />
licens<strong>in</strong>g flexibilities should also be streaml<strong>in</strong>ed, particularly <strong>in</strong> cases where<br />
the response to public health emergencies can be strengthened by rapidly <strong>in</strong>creas<strong>in</strong>g<br />
access to generic medic<strong>in</strong>es. WHO could be funded to provide advice<br />
and assistance to countries need<strong>in</strong>g to use the flexibilities.<br />
A new paradigm for fund<strong>in</strong>g and stimulat<strong>in</strong>g pharmaceutical R&D New ways<br />
to fund and stimulate pharmaceutical R&D are needed to achieve the goal of<br />
universal access to essential medic<strong>in</strong>es and avoid the huge <strong>in</strong>efficiencies and<br />
corruption of the current system. Four <strong>in</strong>novative proposals could stimulate<br />
R&D while reduc<strong>in</strong>g the difference between the sales price and actual cost of<br />
production (Baker 2004b). These are:<br />
• a mandatory employer-based research fee to be distributed through <strong>in</strong>termediaries<br />
to researchers;<br />
• zero-cost compulsory licens<strong>in</strong>g patents, <strong>in</strong> which the patent-holder is compensated<br />
based on the rated quality of life improvement generated by the<br />
drug, and the extent of its use;<br />
• an auction system <strong>in</strong> which the government purchases most drug patents<br />
and places them <strong>in</strong> the public doma<strong>in</strong>; and<br />
114