All about a duel on drugs

All about a duel on drugs The discussions between the South African government and pharma giants on intellectual property policy should keep both the needy and the inventor in mind, notes T S Vishwanath

The South African government and large pharmaceutical companies are in combat mode regarding the proposed national policy on intellectual property that hopes to improve access to medicines for the poorer sections of the population.

Many developing countries and the civil society have backed the proposed policy, and Pretoria is seeking to implement it at the earliest.

The battle is getting serious with the South African Health Minister Aaron Motsoaledi comparing the industry campaign to ‘genocide’.

The draft IP policy, which was prepared in September 2013, hopes to give a push to generic drugs in place of research-based patented drugs that are expensive.

Civil society organisations have reportedly said this would change the current system where drug companies are ‘in a position to have multiple patents on the same drug’.

The new law would make patentability stricter.

The new IP policy, according to Pretoria, is important since South Africa does not have an IP policy now and, therefore, the approach is ‘fragmented’ and not ‘informed by national policies’.

The South African objective of introducing the new IP policy is evident in the policy background, which states that the ‘IP policy needs to take into account that South Africa is a developing country with a bare minimum of technological, economic and social base’.

It goes on to state that ‘policy makers need to consider available empirical evidence before extending IP rights since the interests of the ‘producer’ dominate in the evolution of IP policy, while the interests of the ‘consumers’ are ultimately compromised’.

Out of the 18 different objectives laid out in the draft policy, one of them clearly calls for research, development and innovation in all sectors of the South African economy.

At the same time it also recognises the need for introducing a public health perspective into the national IP laws and adopt a common and united stand among different government agencies on improving access to medicine.

The fight between the large pharmaceutical companies that spend millions of dollars in creating patentable medicines with developing countries and the civil society on the other side is ballooning and this needs some serious debate and solutions.

There is no doubt that the developing and least developed countries have a right to seek access to cheaper medicine for poorer sections that are hit by epidemics such as HIV or tuberculosis.

At the same time, it will be important to adequately compensate pharmaceutical companies who spend billions of dollars in research and development of new medicines.

However, the South African fight against large firms, which sell costlier medicines, seems justified based on a statement by Médecins Sans Frontières that medicine prices in South Africa are up to 35 times higher than in countries where generics have a greater market share.

A big challenge for South Africa, according to the proposed law, will be to ensure that the law enforcers and consumers accept the low-priced generics as a substitute for the costlier medicines.

The draft policy states that it will be important for law enforcers to understand and appreciate that generics are not counterfeit medicines.

At the same time, the proposed policy also says that generic manufacturers have to ensure that they do not stockpile and compete with the original manufacturer before the patent fully expires.

The policy that has been proposed by Pretoria is comprehensive and also has provisions for trademarks, industrial designs and copyright, technology transfer and geographical indications.

The South African government is keen on increasing awareness on geographical indications and ensuring that enough platforms get created for greater recognition and registration of GIs.

The fight over IP protection between large firms and developing country governments is primarily on two fronts -- one is access to medicines and the second is strict enforcement of laws.

While the debate on access to medicines has become heated in the recent months in different developing countries, the issue of enforcement of laws also remains very much alive in bilateral discussions between the developed and developing countries.

In the interest of accessibility to the needy as also valid protection of rights for the inventor, it will be important to remove the animosity that the two sides have been generating in the recent past, and build strong platforms for informed and more accommodative debates that help bring about win-win solutions for the two sides.

T S Vishwanath is Principal Adviser at APJ-SLG Law Offices