Tuesday, June 22, 2010

HIV generic drugs war goes global

KENYA, June 16, 2010 - Government admits to WHO that it made a mistake in drafting counterfeit laws

Kenyans fighting for the right to have access to cheaper generic HIV medicines have won global attention, with the government conceding that it made a mistake in pass-ing a law that could deny its people genu-ine drugs.
Last week, the two ministries of Health were reported in the Economic Times of India as having promised to redraft the offending clause in the Anti-Counterfeit Act, 2008, that threatens to outlaw gener-ic drugs as counterfeits.

Ministry officialsUnnamed ministry officials are said to have told the just ended annual World Health Organisation’s assembly in Geneva that the anti-counterfeit law was pushed by the Ministry of Industry, which had no clue about the possible ramifications.This is the second victory for HIV posi-tive Kenyans in as many months.

UNITAID finally approves patent pool for Aids drugs

Geneva, June 09, 2010 - The long-awaited patent pool for Aids drugs is now officially approved and will start persuading drug companies to give up their monopoly rights in July 2010.  

The final hurdle was surmounted and the launch of the first-ever patent pool for HIV drugs got the official go-ahead on June 08 2010 . The Aids patent pool, aims to kick-start the development of much needed fixed-dose combinations (FDCs) of antiretrovirals in developing countries by pooling patent rights.

According to an article published in the Guardian Global Health Blog, after months of negotiations and expectations, the board of UNITAID - an international organisation set up by European donor countries to increase the supply of affordable medicines to the developing world - voted to set up the Medicines Patent Pool Foundation and give it $4.4 million in its first year. 

The Patent Pool Foundation is expected to hit the ground running in July, persuading drug companies to hand over the patents they hold on Aids drugs so that cheap generic copies for people in poor countries can be made. The greatest benefits are expected to be in the manufacture of drugs in suitable formulations for children and also combinations of drugs belonging to a number of different manufacturers.

"What this means in practical terms," said Philippe Douste-Blazy, chair of the UNITAID Executive Board, "is that formal negotiations with the patent holders can now begin. We expect the Patent Pool Foundation to have its first licenses within a year."

But analysts say that this new patent pool foundation will have a lot of work to do because not every pharmaceutical company is willing to hand over its monopoly rights in a good cause, particularly when it comes to Aids drugs, for which there is a lucrative market in rich countries. 

As it stands, no R and D companies have signed up the patent pool idea yet as there are still questions about the royalty rates that will be given to R&D firms opting to put their patents in the pool. 

This is not the first-ever patent pool. British company GlaxoSmithKline has already established one of its own, but while it has put in patents for drugs that could help against neglected diseases, it has excluded Aids drugs - a field in which it is a leading player. But chief executive Andrew Witty has said he will consider a UNITAID patent pool. 

About the patent pool
A patent pool brings together (”pools”) multiple patents belonging to different owners, and makes them available to third parties against the payment of a royalty.
UNITAID believes that pooling the patents for key HIV/AIDS drugs would make it simpler, and cheaper, for researchers and drug manufacturers other than the patent-holders to access important intellectual property. This would facilitate competition and hence, lower prices, since several different manufacturers could pay the royalty, and then access the intellectual property in the pool to make drugs for sale in developing countries. The ‘one-stop shop’ for intellectual property would also enable innovation, since it would become easier for companies to access the different patents needed to create new fixed-dose combinations, included badly needed ones for children.
UNITAID wants the patent pool to focus initially on HIV/AIDS medicines that are expensive (the newer, ‘second-line’ medicines that receive patent protection in India, a major source of low-cost versions of older drugs) or unavailable (formulations that can withstand hot temperatures, as well as those for children). It wants the licence agreements with patent holders to cover both low- and middle-income developing countries - covering only the former might mean a market for generics too small to yield adequate price reductions.

Malawi now pushes for anti-counterfeit law

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.

About Health Action International Africa

Health Action International Africa is part of an independent global network, working to increase access to essential medicines and improve their rational use through research excellence and evidence-based advocacy.