Check out my latest piece in The Lancet (current issue). Copied below an earlier draft.
India, the leading supplier of low-cost generic drugs to Africa, has begun fighting back to counter the confusion surrounding ‘counterfeits’ in the region. A slew of new and proposed anti-counterfeit laws could potentially deprive Africa’s poorest and needy of affordable, essential medicines.
The immediate cause of concern is Kenya’s Anti-Counterfeit Act 2008 which came into effect in July 2009. The new law, which ostensibly seeks to clamp down on fake (counterfeit) products, blurs the distinctions between generic, substandard and counterfeit drugs, argue critics, including Médecins Sans Frontières (MSF ), the international medical and humanitarian organization. MSF depends mostly on low-cost generic versions of essential medicines to treat patients around the world.
“The definition of counterfeits in Section 2 of the new Kenyan law (Anti-Counterfeit Act, 2008) can be interpreted to refer to generics as counterfeits as they are considered to be “substantially similar goods”. Additionally, sections 32 and 34 of the new law affect the ability to import generic medicines which are at a risk of being classified as counterfeits based on this definition (of counterfeits),” Allan Maleche, a lawyer and member of Kenya Ethical Legal Network on HIV & AIDS told The Lancet.
Kenya’s new law could become a template for others in East Africa — the draft East African policy on anti-counterfeits and anti-piracy has provisions similar to the Kenyan legislation with regard to generics; Uganda has adraft Anti-Counterfeit Goods Bill; and Tanzania, Rwanda and Burundi are discussing these issues.
On 28 January this year, The Economic Times, an influential Indian newspaper, pointed out that India had asked Kenya to make changes in its anti-counterfeit law passed last year that could label generic drugs exported by Indian companies to the country illegal. India has argued, the report said, “that such laws could be counter-productive as it would affect supply of cheap but high quality medicines to the African people.”
In addition to sustained dialogue with Africa’s health ministers and officials in different fora, India’s riposte, over the next few months, will include advertisements in the African mass media and interactive meetings with journalists and industry in several African countries to clear the confusion about the image of generic drugs, said Dr PV Appaji, Executive Director of Pharmexcil, a body set up by India’s Commerce Ministry.
The developments in East Africa are occurring against a worrying backdrop.
Amar Lulla, joint managing director of Indian drug major CIPLA, sees the recent anti-counterfeit initiatives in Africa as part of a campaign inspired by an embattled Big Pharma fighting to preserve market share for brand name drugs.CIPLA is one of the world’s largest producers of generic medicines.
“There has been attempts in recent times to stretch the meaning of ‘counterfeits’ at the local and global level” said intellectual property lawyer Peter Munyi, partner in the Nairobi-based law firm Sisule Munyi Kilonzo & Associates.
However, despite the disturbing trends, all is not bleak.
Besides continuing to publicly question whether the purported aim of tackling the problem of bad quality and substandard products, including medicines, can be achieved using IP(Intellectual Property) based laws and policies, African activists and lawyers are taking their battle to the courtroom.
A petition has been filed in Kenya by three people living with HIV and AIDS challenging the constitutionality of the anti-counterfeit legislation. The three petitioners want the Court to declare the anti-counterfeit law unconstitutional on the grounds that it will deny them access to affordable life-saving generic medicines and therefore rob them off their right to life.
However, “ at this point it is not clear when the suit will come up for hearing” Peter Munyi told Lancet.
In the current scenario, a Ugandan model holds out hope for other African nations, said CIPLA’s Lulla.
The Ugandan model refers to Quality Chemicals Industries Ltd (QCIL), a Ugandan pharmaceutical company that has just started producing much-needed drugs to treat HIV/AIDS and malaria — Africa’s two biggest killers. The factory is now in advanced preparatory stages for WHO pre-qualification.
“ CIPLA has been involved with the QCIL venture from the start, providing technological knowhow and expertise. We have been educating Ugandan health officials, sensitising public opinion in Uganda about the differences between substandard, counterfeit and spurious drugs. We are also in touch with international NGOs such as Oxfam and MSF who are fighting for access to quality medicines at good prices,” Lulla told Lancet.
Indeed, if Uganda is under pressure today to consider amendments to its draft Anti-Counterfeit Goods Bill, it is because public health activists in that country and its own nascent pharmaceutical industry has convincingly and consistently managed to make the case that the proposed law could hinder patients’ access to affordable essential medicines in the country.