India/EU talks a health threat

A trade agreement currently under negotiation between India and the European Union poses a threat to affordable essential medicine still under patents and antiretrovirals (ARVs) for HIV/Aids victims in South Africa and sub-Saharan Africa. It could include treatment for conditions such as cancer, diabetes (a huge problem in Africa), tuberculosis or even a future epidemic.

The extent of the seriousness of the threat of an insistence by the European Union for an extended period of protection of information under the agreement is illustrated by the fact that due to an easing of patent and licence restrictions, the price of ARVs fell from more than R3 000 per month in the 1990s to less than R150 per month presently. This is in nominal terms, and does not even take into account the effect of inflation.

In a letter last week to the High Commissioner for India in South Africa, the Treatment Action Campaign (TAC) wrote that without these massive price reductions, nearly a million additional people in the country would be dead or dying.

Furthermore, the price reduction has not only benefited South Africans. People far beyond its borders benefit because many sub-Sahara African countries can now provide quality ARV drugs because it is affordable.

The TAC letter, however, pointed out that “the prospect of making new ARVs available in South Africa at affordable prices is under threat because of events unfolding in India. In particular, pressure is being applied by the European Union on the Indian government to sign a bilateral trade agreement that will stifle competitions on essential medicines still under patent."

How prices came down

The letter went on to explain that until the early 2000s, each ARV was marketed exclusively by one company or via an exclusive licence from the patent holder.

Generic manufacturers based mainly in India, but also in Brazil and elsewhere, produced dramatically cheaper versions because these medicines were not patented there.

Activists forced patent holders to license generic manufacturers to sell their medicines in sub-Saharan countries and elsewhere. As a result, companies manufacturing ARVs and other important medicines under patent either dropped their prices dramatically or allowed generic competition.

In 2005, however, India passed legislation that allowed medicine to be patented as required by the World Trade Organization (WTO). Medicine developed since can no longer easily be generically produced there and complicates campaigning for affordable medicine prices.

The TAC cited an example of a new and important ARV, raltegravir – particularly to people resistant to standard ARV regimes – for which the price is an unaffordable R2 396 per month.

“With no competition there is no downward pressure on the price, and it is extremely unlikely to be accessible to people in South Africa in the near future.

“At least two new tuberculosis drugs are likely to be ready for registration in the next few years. These are urgently needed, especially in light of the growing drug-resistant TB epidemic. It is a matter of deep concern that they might not be accessible where they are most needed: in poor countries,” the TAC wrote.

It will worsen

The situation, however, is worsening since a leaked draft of trade agreement between the EU and India indicates that the Europeans are insisting on:

An enforced period of data exclusivity for new drugs of between five to nine years, which will make the development of generic drugs nigh impossible;

Longer patent periods than the present 20 years to include the period used by regulatory authorities to register a new medicine;

The right of seizure of medicine in breach of EU patents, even if it is only in transit to country outside the EU, such as in sub-Saharan Africa.

The TAC cited an example of the seizure of a shipment of abacavir sulphate on is way from Inda to South Africa, which was ironically funded by the US-based Clinton Foundation.