Intellectual protection issues come to the fore

Intellectual property issues have been a hot topic for various governments over the last few weeks, with significant developments occurring in Brazil, the Philippines and India. Earlier in April, the Brazil Health Ministry declared the antirretroviral drug tenofovir to be in the ‘public interest’, signalling its willingness to import a generic version of the medicine. The Health Ministry’s declaration indicates that the patent for the drug could be rejected due to its high price; this could then lead to negotiations over the import of a generic version.

At the end of last month, the Philippines also turned against branded manufacturers, with its Congress approving a bill that strongly promotes generic medicines. The new law, which still requires approval from the President, will allow limited parallel importation, should help to prevent incremental innovation, will allow local generic firms to register their versions before patent expiry, and could permit the use of compulsory licences for the public good.

Conversely, one region which has traditionally been without strong intellectual protection laws for years, India, is now looking to clamp down on marketing approvals of drugs already patented. The Drug Controller General of India has published a reference guide and hopes to co-ordinate with the Ministry of Health to create an integrated approach which will link patents together. Following this, the DCGI will then prevent any approvals for generic versions of patented drugs. To date, patent linkage in India has proven difficult, as it has been impeded by a decentralised and inefficient drug approval structure. Unsurprisingly, domestic firms in the country are against such moves, arguing that they will be unworkable in practice.

The motivation behind moves to promote generics through intellectual property reforms are clearly motivated by the high costs of patented drugs. Interestingly, think-tank African Liberty has recently questioned the link, noting that low uptake of drugs was more likely caused by poor infrastructure. Either way, governments in developing countries are likely to continue putting pressure on IP rules, as weakening them in favour of generics appears to provide them with a quicker fix to long term drug expenditure problems.

Jonathan Way - Editor, World Generic Markets