Intellectual Property Rights, Generic Drugs and Africa Health

Africa has the majority of people in the world who live on less than a dollar a day. Click here to Buy Kapake 30mg/500mg Tablets from NHS Heroes in the UK It is also where 11 percent of the world’s people live and has 25 percent of the world’s disease burden. In addition, per capita public health spending is very low ( as low as $50) compared to countries such as the United States where public health spending is about $7,000 per person.

Considering the heavy burden of diseases and the low public health spending, it is critical that the meager resources cast a wide net to reach as many people as possible. This has been made possible through the use of generic drugs. For example, within the last decade the price of AIDS treatment fell from $10,000 to $100 per year per person due to the availability of generic anti-retrovirals which created a public health revolution by allowing millions of poor people to access these lifesaving drugs.
Recently, the Obama administration placed India in its trade black list after some Courts in that country made a ruling allowing some generic versions of expensive drugs. The Office of the US trade Representative in its Special 301 Report objected to some aspects of India’s Patent system. Although placement of the list may not attract much attention and may have little impact, it is a bullying tactic that has a chilling effect on any nation that seeks to produce generic drugs.

Indian courts ruled in one of two cases – that the production (compulsory licensing) of a generic alternative to Never, a cancer drug, which is patented by German drug maker Bayer AG and costs over $5,000 a month for a standard dose – way too high to be affordable, while a generic version cost $157. Still, under the ruling Bayer gets 6 percent of the royalty on the sales of the generic drug.
In July 2012, a representative of the U.S. Patent and Trademark Office called this decision an “egregious” World Trade Organization (WTO) violation as it was not being manufactured in India. It is worth noting that compulsory licensing of generic versions is protected by WTO treaties when its goal is to improve public health.

While it is understandable that Research and Development (R&D) for drugs is expensive as are the regulations, pricing the drugs at $5,000 a month puts is out of reach for too many people and thus the push for generics can be expected. And, considering that the generics are available at $157 a month in India, there should be room for an agreement.

In a second case, India ruled against a patent filed for an updated version of a cancer drug Glevec manufactured by the Swiss pharmaceutical Novartis. The court argued that the newer version did not constitute a new breakthrough worthy of monopoly pricing power. This is one of the strategies that some pharmaceuticals use known as “evergreening”- basically making a very minor upgrade, such as changing one molecule to an existing medication and then request for patent that extends monopolies beyond the standard 20-year period. The Obama administration objected to the ruling saying that it “may have the effect of limiting the patentability of potentially beneficial innovations”. As a result of the India’s court’s ruling Glevec costs ten times less in India as it costs in South Africa.

Incredibly, some African countries are being pushed to pass anti-generic druglaws – making it harder to produce or import them into their countries despite the obvious benefits of these low priced versions for resource poor settings. For example, Kenya has already ratified an anti-generic drug law that will force its people to buy drugs that are ten times more expensive but not more effective than generics. Camouflaged as an anti-counterfeit law it makes it possible for generics drugs exported from any country which are patented anywhere else to be classified as counterfeit if the patent holder raises an objection. Uganda and Zambia are also under pressure to pass similar laws. Indeed, India has been sensitizing African health ministers to resist pressure to prohibit generic versions of drugs.
Considering the fact that Non Communicable Diseases (NCDs) such as cancer are becoming a major problem in Sub Saharan Africa and will surpass communicable diseases (malaria and AIDS) as leading causes of death in the next decade, availability of treatment for NCDs such as cancers are of immense importance to the continent. In addition, the fate of India is linked to that of African countries which have limited capacity to produce generics of their own; South Africa is the only country that produces active pharmaceutical ingredients mostly of non-specialist drugs.

It is to be noted that India’s generic drug industry has been a major factor in increasing access of various treatments to the poor. In the early 2000s, treatment for AIDS was totally non existent in poor countries until the Indian generic drug manufacturing came into existence. Even the US President’s Emergency Plan for AIDS Relief has been able to expand its treatment greatly through the use of cheaper generic drugs.

However, some pricing obstacles still remain, especially for second line treatments. For example, the combination treatment Lopinavir + ritonavir manufactured by Chicago based Abbott which is a key component of many AIDS treatment is priced at $400 in poor countries and as much as $1,000 – $4,000 in middle income countries. This has meant that prices of second line treatments remain high.

It is worth noting that the US and Big Pharmaceuticals are pushing for stricter intellectual property. In Paragraph 6 of the “Doha Declaration on TRIPS and Public Health” adopted by WTO members signed in 2002, it was agreed that the poorest countries should have access to generics of life saving drugs.
However, the eventual “diluted” Paragraph 6, agreed to in July 2003 due to delays occasioned by US government inflexibility, the conditions were such that the amendment did not provide the anticipated feasible solution. Efforts to amend Article 31 of TRIPS in 2005 to offer a straight forward solution met resistance. Enforcement of TRIPS (Trade related Aspects of Intellectual Property Rights) standards through the WTO and the Doha round due in Bali in December 2013 would remove the ability to resort to generics. So, for Africa’s health sake we are rooting for the coming Doha round to fail.

While it is important to have policies that balance medical innovation it is also vital to ensure that essential global health challenges are addressed through a generic market. While Obama administration emphasizes consumer affordability in its domestic posture such as in related to the Affordable Care Act, it seems to be turning the a blind eye when it comes to its posture abroad. Its laudable goal of an “AIDS Free Generation” will be impeded by patent monopolies and high treatment costs.

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