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.


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