Nigeria plans local production of ARV drugs
By Chukwuma Muanya, who was in Geneva
APPARENTLY to forestall future scarcity, the Federal Government plans to begin the local production and bulk purchase of Anti-Retroviral (ARV) drugs.
Indications have emerged that the supply of cheap generic drugs to developing countries may face some hitches as India plans to start patenting such medicines by 2011. India is a major supplier of cheap ARV drugs to Nigeria and other developing countries.
Minister of Health, Prof. Babatunde Osotimehin and Director-General of National Agency for the Control of AIDS (NACA) and Chairman Nigeria ARV Committee, Prof. John Idoko, in separate interviews with The Guardian at the World Health Assembly (WHA) in Geneva, Switzerland, said there were moves to start the local manufacture and bulk purchase of ARVs .
A generic drug is an identical copy (bioequivalent) of a brand name (or proprietary) drug. In order for the proprietary drug makers to recoup the money they spent on drug creation, they are granted a 'patent' (an intellectual property right), which is an exclusive right that prevents others from making, using, selling, offering to sell, or importing their drug. The patent typically lasts for 20 years.
Generics have been shown to be exactly the same as their branded counterparts in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use. The notable difference between the two is the price.
ARVs are drugs for treating People Living With Human Immuno-deficiency Virus/Acquired Immune Deficiency Syndrome (PLWHA). It has been shown that the survival rate of patients infected with HIV/AIDS has risen dramatically due to availability of affordable generic drugs in Nigeria. Presently, no fewer that 300,000 PLWHA are receiving treatment with generic ARV drugs.
Legislation in favour of the pharmaceutical industries' right to patent their drugs - Trade Related Aspects of Intellectual Property Rights (TRIPS) - was introduced in 1995.
TRIPS introduced intellectual property law into the international trading system for the first time and applies to all members of the World Trade Organisation (WTO).
Because the implementation of TRIPS was to have a huge impact on generic drug production, the majority of developing countries were given a ten-year transition period in which to comply. This means that developing countries (such as India) were able to continue developing generic drugs until 2005, whilst least developed countries have until 2016.
But India, under a new TRIPS agreement, plans to stop allowing generic versions of ARV by end of 2011.
The Guardian learnt that the patent law, enacted to bring India in line with WTO rules, frustrates some companies in the country's large pharmaceutical industry, which makes copies of many Western medicines. International organisations providing medical aid and advocates for patients fear that the law could cut off their access to affordable generic drugs.
Osotimehin said: "You know we are going to look at the TRIPS agreement and make sure that we are not caught napping. As I speak with you, there are several initiatives on ground to produce drugs in Nigeria. We lighted them from the patents that are available and I think that those are the critical things we have to look at to ensure that we do not have any stock out or any shortages when it happens."
The minister said he had started talking with the Pharmaceutical Group of the Manufacturers Association of Nigeria (PG-MAN). "But we have to work with regulatory bodies and pharmaceutical industries. I have met with the chairman of PG-MAN and we talked about how government is going to assist them in getting to become more competitive in their industries and we have recommendations, which they are going to adopt so that they can attain good Manufacturing Practice status, and then they can pre-qualify. All of that can happen so that we can boost local production and make sure of security of drugs and commodities," he said.
Osotimehin said the country has the capacity to produce enough ARVs for over 300,000 PLWHAs. "When we started the ARV treatment, the world told us that we had no capacity to treat patients who are HIV positive. Today, we are treating 300,000 people and more would be in view of treatment. I think it is a matter of national commitment and I believe that the President is committed to making this happen and I have no doubt in my mind that this is something that we are going to do," he said.
Idoko said: "The issue of India's new patent law was discussed at the level of the Nigerian ARV Committee, which I chair. It has also come up at a TRIPS meeting here at the World Health Assembly (WHA). We realised that after this year, we may no longer be able to access generics from India.
"The best option for us is to manufacture. At that point, there were many suggestions on the table. One was that we have a number of indigenous pharmaceutical companies that are going to produce generic ARVs. As you know, some are even supplying some West African countries.
"We also know there are a number of Indian companies that have partnered with Nigerian companies to produce ARVs. Evans and Ranbaxy are producing paediatric formulation. The other option available is that a company in India can licence a Nigerian company to produce its own product. We have not exploited that option so well.
"The most attractive option is the South-South option which Brazil has taken upon itself to transfer technology and sole rights of manufacture to a number of countries in the south for about 15 years."
Idoko said for a short-term measure, the Federal Government is planning bulk purchase of ARVs.
"The only condition that can help now so that the over 300,00 PLWHA who are on drugs will not suffer any disruption is on the short term measure. We know that ARVs have a shelf life of about six months and the paediatric formulation that we now produce in Nigeria have a shelf life of around one year.
"One way of bridging the gap now is to procure, and the government is doing that. This gives us time as we would have enough supply for the next two years. As we know, a number of our partners involved in ARV therapy and development partners such as Joint United Nations Programme on AIDS (UNAIDS), Global Funds, United States President's Emergency fund for AIDS Relief (PEPFAR) already are importing drugs from South Africa and other places," Idoko said.
