Malawi, 12 June 2010 - Health activists in Malawi have expressed concern at the Malawian government’s intention to pass a new bill against counterfeit goods by October this year which will also cover medicines.
This step is being taken despite fears that such a law may cause more stock-outs in a country that is already riddled with frequent drug shortages in medical facilities.
An article published in Malawi News said the activists fear that this proposed law could legislate against generic drugs on which Malawi’s health care system heavily relies.
In keeping with World Trade Organisation (WTO) and international trade agreement terms, countries in East and Southern Africa are introducing laws reportedly to crack down on infringement of trademark and intellectual property rights.
Malawi News indicates that the Malawian government is said to have sidelined health activists in the preparation of the proposed law and is allegedly denying them access to the document saying it is not for public consumption.
Alerted by the content of laws that have been enacted so far in some countries in Africa, health activists here fear that Malawi’s law could adopt a wide erroneous definition of counterfeits and legislate against legitimate products such as generic medicines.
Speaking on behalf of the organisations, Executive Director for the umbrella body Malawi Health Equity Network (MHEN) Martha Kwataine said enacting a law against generic medical products will reverse Malawi’s efforts in improving health care and worsen drug stock outs in hospitals.
“All our drugs for HIV/Aids, malaria, tuberculosis and many others are generic, manufactured in India and are cheap. This means we can provide good health care to Malawians at a cost that suits our purse” said Ms Kwataine who further observed that with the new laws and the misunderstanding of what counterfeits are, it will be difficult for poor countries like Malawi to afford and access those medicines.
She said production of generic medicines has become a fierce competitor to the brand-name owners, hence the new laws. “These new laws will worsen the situation because they will restrict the flow of generic drugs and affect quantities we can purchase at one time. This situation will aggravate stock-outs of drugs in the country.”
Ms Kwataine said pharmaceutical companies should not put profits first at the expense of public health. She said the bill needs to be scrutinised properly to see whether it deals with the exact meaning of “counterfeit”. She however reported that the government has refused to give them a copy of the bill. .
The MHEN boss accused her government of acting in secrecy over the issue of the bill and claimed that it was serving the interests of multinational pharmaceutical manufacturers while putting lives of millions of Malawians on the line. She says her organization may consider asking the courts to stop the bill from becoming law.
Acting Registrar for Pharmacy, Medicines and Poisons Board (PMPB) Aaron Sosola Sosola was quoted in Inter Press Service (IPS) article as saying the bill has already been vetted by the Cabinet and that the proposed law is intended to protect people from counterfeit drugs through specific strict measures against peddlers of counterfeits.
According to Sosola the penalties articulated in the new law include a 10-year prison sentence and K50million fine.
A policy brief released last month by the Regional Network for Equity in Health in East and Southern Africa (EQUINET) says generic medicines are lawfully produced and they are the same as the original brand name product.
They contain the same ingredients but are not made by the company that first developed, marketed and often patented the drugs, says the statement.
The document reads in part. “Because generics are in general a lot cheaper than patented products, they have played a huge role in making sure people have access to essential medicines in Africa and other developing regions, where, for instance, people overwhelmingly rely on quality generics for anti-retrovirals drugs to treat HIV/AIDS,”
EQUINET observes that the laws being put in place so far are confusing counterfeit, substandard and generic medicines. Counterfeit medicines are deliberately and fraudulently mislabeled in terms of identity and/or source, thus violating intellectual property and subject to legal action.
“Substandard and falsified medicines are those that do not meet quality, safety or efficacy standards and thus pose a health risk to consumers. Controlling substandard, falsified medicine calls for special measures and competencies and should be the responsibility of national drug regulatory agencies,” says EQUINET in the brief.