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Thursday, June 30, 2016
- Access to affordable medicine for millions of people in the South could be at risk if the production and distribution of generic medicine from India is restricted.
Campaigners say both Kenyan legislation and a European Union-India trade agreement to be concluded this year will block access to affordable drugs.
Counterfeit goods are seen as a threat by government and industry alike. As in many other developing countries, a heavy reliance on generic medicine in Kenya is held responsible for the permeation of counterfeit drugs. Unscrupulous traders are believed to fraudulently mislabel various products as legal generic drugs which are sold to unsuspecting consumers.
In addition to the health risks posed by fake drugs, the trade in counterfeit medicines costs the Kenyan government 75 million dollars in lost tax revenues every year; manufacturers incur a net loss to their profits of over 375 million dollars.
To curb this, and similar losses to manufacturers of other goods, Kenya passed the Anti-Counterfeit Act in 2008. The Act defines counterfeiting as “the manufacture, production, packaging, re-packing, labeling or making, whether in Kenya or elsewhere, of any goods whereby those protected goods are imitated in such manner and to such degree that the counterfeit goods are identical or substantially similar copies of the protected goods.”
The problem, according to Dr Onyango Opiyo, the Executive Director of the Nairobi Network of Post-Test Clubs (a community-based organisation that supports people living with HIV/AIDS), is that legitimate generic medicines are being caught up in the net. “The concern is over the EU-India Free Trade Agreement and the Anti-Counterfeiting Trade Agreement which have provisions whose impact will be to delay production of affordable, quality generic versions for up to 10 years. This would inevitably drastically reduce access to life-saving generic drugs.”
The European Union is expected to sign a trade agreement with India this year; campaigners in Kenya, India and in Europe are concerned that the new agreement will hamper the manufacturing of generic anti-malaria and anti-retroviral drugs that are widely used in Africa.
Generics vital to health programmes
It is estimated that 1.4 million Kenyans are living with HIV/AIDS – according to the Kenya AIDS Indicator Survey – 400,000 patients are already receiving free anti-retroviral treatment.
The number will rise by an additional 70,000 in the next two months in a government bid to increase access to the life sustaining drugs, in accordance with the Millennium Development Goal of curbing HIV, TB and malaria.
In recent years, cancer has also placed an increased burden on the health sector. Dr Opiyo, who is also Head of the Cancer Treatment Centre at Kenyatta Hospital in Nairobi, says his centre receives 4,000 cancer patients per year.
Besides cancer and HIV/AIDS, the country is battling with many other illnesses like TB and malaria; treatment with branded drugs is prohibitively expensive, and health professionals must rely on generic drugs to cover more people who need care.
Expanded treatment has only been made possible through access to generic medicines, which are available at a fraction of the cost of branded product, but without compromising quality.
Jack Kamonya, an anti-HIV activist and primary school teacher says that in the 1990s, the cost of patented antiretrovirals ranged between 10 and 15 thousand dollars a year – well out of reach of the majority of Kenyans and far too costly for the government to consider supplying through the public health system.
With the entry of Indian-produced generic equivalents, the cost of a year’s supply of antiretroviral therapy is down to just 88 dollars per person.
“Generics make up for an estimated 90 percent of all drugs consumed in Kenya. Even without the prohibitive Act, malaria drugs, antibiotics and ARVs are generally under stocked for various reasons such as a lack of resources,” says Kamonya.
Challenging anti-counterfeit measures
But these affordable generics are running afoul of measures supposed to be aimed at counterfeits.
“We are unhappy with the initiatives that the EU is undertaking in its trade agreement negotiation in the fight against counterfeit drugs. These initiatives will greatly hamper access to generic medicine and for someone like me who is on ARVs, it is indeed a death sentence,” explains Kamonya, who was among members of civil society, health activists and patients in need of generic drugs who marched from the Ministry of Health Headquarters in Nairobi to the European Union House in December 2010 to protest various initiatives to fight counterfeit drugs.
In a report on the subject of counterfeit medicines, Betty Maina, Chief Executive of the Kenya Association of Manufacturers, wrote, “Generic drugs are not be confused with counterfeits or a sub-standard product. These are dissimilar in all ways.”
She says that counterfeit medicines are drugs that are “deliberately and fraudulently mislabeled in regard to their identity or source, while generics are those that are produced and distributed without patent protection.”
In February, the Corporate Europe Observatory, a Dutch group that exposes privileged access of business interests to European Union policy-making, sued the EU executive for access to information about negotiations over the EU-India Trade Agreement.
The Observatory fears that India’s production and distribution of generics will be limited by the new agreement, and had spent 18 months requesting detailed information. Documents they received had key passages deleted – but European corporations’ representatives have had full access.
The various campaigners see a dangerous influence on policy by business in both the trade negotiations and Kenya’s legislation.
Kenya’s anti-counterfeit legislation, say campaigners, is protecting the intellectual property rights of the original developers of drugs under cover of protecting consumers from inferior medication. The World Trade Organisation’s regulations allow governments to exploit a patent in the public interest – for example to purchase cheap generics to fight HIV.
Three people living with HIV have sued the government. Their case challenges the definition of counterfeiting as unconstitutionally blocking access of the three plaintiffs – and millions of other Kenyans – to essential medicines.
Kenya’s Constitutional Court has already barred the government from implementing the section of the Anti-Counterfeiting Act that relates to generic medicine, in response to the lawsuit.
What is at stake in both Kenyan and European courts is hard-won progress in managing AIDS, malaria and other serious diseases. Millions of Kenyans and others dependent on affordable medicines await the rulings with bated breath.
“It has been a long battle to be accepted as a person living with HIV/AIDS, the society has only accepted us because they can see it is not a death sentence, without life saving drugs, people will begin to fear the condition,” says Mary Munya , a vegetable vendor in Kibera Nairobi who lives with HIV/AIDS.