An overview on IP Law and access to medicines

Today, more than two billion people across the developing world lack access to affordable medicines. In particular, there are two critical factors that limit access to treatment: the high prices of new medicines (particularly those that are patent-protected) and the lack of medicines and vaccines to treat neglected diseases. As stressed by professor Watal, the right to have access to essential medicines has been linked to the right to health. The point is that there is no definition of the concept: should we consider essential medicines are those contained in the list of the World Trade Organization or defined at a national level? The perspective, in this case, may wide or tighten the definition. Furthermore, the issue is strictly linked to the protection of intellectual property rights; there is the need of a balance between the short-term interest in maximizing access to medical technologies and the long-term interest in promoting creativity and innovation. On the one hand, governments need to maintain an appropriate balance between innovation and ensuring new products availability. High levels of IP protection in developing countries exacerbate the problem of access to affordable medicines. Extensive patent protection for new medicines delays the onset of generic competition. And because generic competition is the only proven method of reducing medicine prices in a sustainable way, such high levels of IP protection are extremely damaging to public health outcomes. All the sectors of technology, thanks to the TRIPS Agreement, are included in the possibility to get a patent. There is no discrimination as to the place of invention, field of technology and place of production. The requirements are simply: namely, novelty, inventive step and industrial applicability. According to the TRIPS Agreement the key element of a patent is the fact that there is a disclosure requirement according to which important technical information have to be publicly available for those who may need them in advancing technology in the area (also during the patent term) and, after the expiry of the patent term, the invention falls into the public domain. As highlighted by the Doha Declaration, member countries intellectual property rights can be limited or qualified by member states; furthermore, the Declaration underlines that the TRIPS Agreement does not and should not prevent Members from taking measures to protect public health. It reaffirms the right of Members to use the provisions of the TRIPS Agreement that provide flexibility for this purpose. Through these important declarations, all WTO Members have signaled that they will not seek to prevent other Members from using these provisions. The Declaration also makes clear that the TRIPS Agreement should be interpreted and implemented in a way that supports WTO Members’ right to protect public health and, in particular, to promote access to medicines for all. Additionally, every member is free to determine the grounds upon which compulsory licenses are granted. This is a useful corrective to views often expressed in some quarters that some form of emergency is a precondition for compulsory licensing. The reference to national emergencies or other circumstances of extreme urgency in connection with compulsory licensing makes clear that each Member has the right to determine what constitutes “a national emergency or other circumstances of extreme urgency.” Public health, for sure, may be included in this exemption. In the field of IP protection regarding public health, the balance between right holders and users of intellectual property rights may be sought. What is clear is that improving access to medicines is not only related to IP protection. Many other factors, such as political will, funding and health-care capacity have to be included.