[Ip-health] The Guardian: Decision time on drugs for poor countries
Judit Rius Sanjuan
judit.rius at keionline.org
Thu Jan 20 10:09:14 PST 2011
Decision time on drugs for poor countries
Posted by Sarah Boseley Thursday 20 January 2011 15.06 GMT guardian.co.uk
The Indian prime minister's office is thought to be on the brink of sealing a trade deal with the EU, which medicines campaigners fear could stop the flow of cheap lifesaving drugs to the poorest countries in the world
Deep anxiety has set in among those who worry about the chances of people living in impoverished countries getting the drugs they need when they fall sick. India, dubbed the pharmacy of the world, appears to be on the point of agreeing a trade deal with the European Union which would prevent its generic pharmaceutical companies from making cheap copies of expensive drugs. Look at any pharmacy in sub-Saharan Africa, and those are the drugs you will see on the shelves. The impact of India's decision, say campaigners, could be dire.
The negotiations and the row over them have been going on for some considerable time. Here is a piece I wrote about it last October. But now, it appears things are coming to a head. The Prime Minister's office is understood to be involved and it is thought a decision is imminent.
Back a few years, the argument over access to medicines was all about patents - the 20 years' copyright protection given to a pharmaceutical company so that it could recoup the millions of dollars it had invested in research and development. A World Trade Organisation agreement on intellectual property required all nations to respect patents - but campaigners won an exemption to allow generics firms to make cheap copies for poor countries.
Big Pharma was down, but not out. The big, research-based drug companies consider the generics companies a major threat to their profits. There is every sign that they are behind the clauses in the EU trade agreement that could end the flow of cheap copycat drugs in the developing world. The trade agreement asks for "data exclusivity" on drugs, for a period which may be five or may be ten years.
This stops generic companies in their tracks. At the moment, they can make a copy of a drug and all they have to do is demonstrate that it is bio-equivalent to the original - they don't have to do new trials. Their drug can be licensed on the basis of trials carried out by the original company. Data exclusivity would stop this happening. Unless the generics company carried out its own trials, it would not be permitted to market a copycat drug.
Does a delay of five or ten years matter? Oxfam and Médecins Sans Frontières consider it a matter of life and death. The obvious example is HIV/Aids. The virus mutates easily and fast. In rich countries, resistance has set in to one drug after another. Poor countries at the moment have generic copies of basic drugs, but as resistance spreads, new drugs will be needed. Patients will not be able to wait ten years for the data exclusivity on those new drugs to expire.
Rohit Malpani from Oxfam points to a study they carried out showing that the introduction of data exclusivity in Jordan led to higher prices and delays in the introduction of generic medicines. You can access it here. http://www.oxfam.org.uk/resources/policy/health/bp102_trips.html
India has held out against EU/pharmaceutical pressure for some time, but local reports are now saying the Prime Minister's office may accept their terms in order to get a wider trade deal through.
Michelle Childs of MSF says the present Indian rules have served the cause of global health well. An Indian court recently ruled that Abbott's drug Kaletra, vital to the HIV fight in Africa, was not protected by patent and could be copied. I blogged on that here. http://www.guardian.co.uk/society/sarah-boseley-global-health/2011/jan/04/aids-pharmaceuticals-industry This is what Childs says:
"Indian patent laws have been shown to work to stop unnecessary patents on HIV medicines. Data exclusivity would undermine the benefits by giving a monopoly to stop production even when the patents have been removed."
Judit Rius Sanjuan
Knowledge Ecology International (KEI)
NYC Phone: 212 222 5180
Washington DC Phone: 202 332 2670
More information about the Ip-health