Intellectual Property, transfer and accessibility of medical technologies : between the market and public health

1. Intellectual Property, transfer and accessibility of medical technologies : between the market and public health Maurice Cassier, CNRS, Paris

2. 1- Globalisation of Pasteur’s vaccines in the late 19th and early 20th centuries • The human vaccines invented in this period circulated relatively freely in many countries : they had a status of free and common goods not appropriated by IPR’s • Pasteur was quick to promote the dissemination of the rabies vaccine through the creation of local laboratories in many countries : transfer of know how and of the raw material in the form of rabbits inoculated with the rabies virus

3. 2- Dissemination of health technologies and the issue of quality control : the BCG vaccine • The BCG strains produced by Calmette in tle early 1920’s were made available to any laboratory that requested them : the vaccine had clearly a common good status • This free accessibility of BCG strains had the infortunate consequences of the vaccine accident of Lubeck in Germany in the early 30’s • The globalization of vaccine preparation methods implied not only their unrestricted access but also the standardization of biologicals and the extension of the regulation of good manufacturing practices

4. 3- Globalization of insulin in the interwars : a biopolitics of drugs invented by a university • The discoverers of insulin in 1922 decided to patent their discovery in order to exercise a control over the industry via patents and licences • Through patents, the University of Toronto had the power to control both the quality and prices of insulin • The University created a « patent pool » among all its licencees so that no laboratory could be excluded from the market • This particular economy policy appliying to insulin was extended to north America, most european countries, south America, Australia and Egypt

5. 4- Globalization of medical technologies in the context of patents and exclusive markets : breast cancer genetics in the 1990s • The globlization of breast cancer genetic testing has been market by a conflict between a private laboratory which wants to extend a monopoly on the breast cancer market and a consortium of university and hospital laboratories which have the technology and wish to offer theses tests freely to patients • In Europe, the hospital laboratories have opposed the genes patents and had won the battle in the European Patent Office : in 2004 breast cancer genes recovered the status of free and common goods

6. 5- Globalization of ARVs in the context of copying drugs in India and Brazil • The dissemination of ARVs is the result of reverse engineering that was allowed by an asymmetry of IPRs between theses countries and those of the North : copying was absolutely licit • In India the main driver of the copying of ARVs was the market ; in Brazil, it was public health policy • This copying resulted in technological learning in the local laboratories that reinforced their R&D capacity and quality control

7. 6- Extension of TRIPS an the challenging of local health products manufacturing • The local production of drugs was challenged once there was no more asymmetry of IPR between Brazil and India on one hand and countries of the north on the other • The dissemination of patented health technologies requires either voluntary or compulsory licences • In the past, compulsory licences for pharmaceuticals were merely used by countries of the north (EU, GB, Germany)

8. 7- Using compulsory licences for domestic or export markets • New possibilities were opened by compulsory licences for exports in 2003 and that possibility sould be used by countries of the South, including Brazil, to create a South-South Market for active principles and drugs • Contrary to common belief, the law on theses licences has yet to be made : in 2004, Malaysia decided on a compulsory licence for importing four ARVs from Cipla in India ; in 2005, India integrated compulsory licences for exportation into its new patent law

9. 8- Using flexibilities and creating legal precedents in the IPRs • Intellectual property plays an increasing part in the diffusion and accessibility of health technologies • Yet in the case of medical technologies certain measures provide for exceptions or for flexibility : these measures have to be endorsed by favourable legal precedents

10. 9- dissemination and safety regulation for health products • The regulation of the quality and therapeutic utility of health products also palys a key part in the dissemination of medical technologies ; safety regulation could be a basis for exclusivity • It is necessary to organize a gradual process of certification to favour learning rather than creating new barriers to the entry of new actors in the field: ex : from the production of similar drugs to the certification of generics in the field of ARVs in Brazil

11. Conclusion: Market and Biopolitics • Market mechanisms have to compromise with public health policies and with the ethics of medical access defended by doctors, patients organizations and other NGOs • There is thus a biopolitics of drugs supported by states and various actors, which cannot be reduced to the market mechanisms • Intellectual property - and its exceptions and flexibilities- and safety regulation - drug agencies, WHO - are key instruments for this biopolitics