Working at accessing medicines

By Joe Maila Time of article published Nov 2, 2015

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South Africa has a long and proud history in addressing the barriers that patents present in the access to medicines.

Much of the groundbreaking work done by the democratically elected government post 1994 in partnership with different stakeholders, has influenced global policy on patents and their effect on access to medicines.

In this regard, the Medicines Act was amended to make provisions for Section 15C which allows for the minister to authorise the parallel importation of a medicine where the same medicine (from the same manufacturer) is more affordable than in another country.

Parallel importation involves the importation of the same medicine (produced by the same manufacturer) at a lower price from another country.

The affordability of medicines is not the only consideration where parallel importation is necessary. Where a supplier is unable to produce adequate quantities of medicine resulting in patients going without treatment, then parallel importation can be invoked. In this regard the minister may consider invoking the provisions of Section 15(c) of the Medicines Act.

This is consistent with what is in the Trips Agreement.

The Department of Health has explored various options to address the public health priority issues. In particular, the abandoned essential medicines that companies have lost interest in their production, the needed antiretrovirals that are in short supply.

The two options that the Department of Health has explored with Section 27 and the medicines patent pool in Geneva are parallel importation and licensing through patent pools.

South Africa is also a signatory to the Trips agreement. This provides for flexibilities which allow countries to implement measures that will improve access to medicines and also allow for public health safeguards.

These Trips flexibilities include non-commercial use of patents, parallel importation, exceptions to patents rights, compulsory licensing exemptions from patentability, limits on data protection.

Compulsory licensing is not the only option available.

There are a number of instruments available to South Africa to address access to medicines where intellectual property poses a barrier to accessing medicines, especially if it is of public health concern.

This barrier to patents can be addressed through voluntary or compulsory licences and a number of other instruments including parallel importation.

The use of patent pools is a mechanism that we have explored, which will benefit not only South Africa, but other countries that can access the licences that have been made available in the pool. Voluntary licences involves the patent holder voluntarily entering into an agreement with a supplier to sell a patented product in a defined market since the price will be lower than that of the patent holder and more affordable.

Because of supply problems and the recent problem of abandoned essential medicines, the patent holder must provide the licence through the Medicines Patent Pool for production of such medicines.

The best option for voluntary licensing is through the UN backed Medicines Patent Pool which has to date negotiated 12 public health licensing agreements for key HIV treatments and all of which have included South Africa.

The sole purpose of the Pool was to issue licence agreements that would be used to improve access to HIV treatments to countries like ours and to other low and middle income countries. Initially the Patent Pool addressed only HIV treatment, however this has now extended to TB treatments.

We hope that this mechanism can be used to address abandoned essential medicines and those that are urgently needed. We will work in partnership with the UN, Medicines Patent Pool, and the patent holders to immediately allow us to access alternative sources.

* Maila is the spokesman for the Department of Health

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