By Evelyn Kwamboka
The United Nations has been enjoined in a case challenging the Government’s decision to ban generic drugs for HIV and Aids.
It claimed enforcement of the Anti-Counterfeit Act 2008 would endanger the lives of the infected.
The High Court in Nairobi heard those affected would not access affordable and essential drugs.
"The Special Rapporeur wishes to intervene as an interested party to support the constitutional principles of access to essential medicines," advocate Ombati Omwanza said yesterday. Justice Daniel Musinga allowed Mr Anand Grover to represent the UN in the suit.
Generic drugs
The court had allowed importation of generic anti-retrovirals, pending the hearing and determination of this case.
The interim order issued in April was aimed at saving the lives of those living with the virus. The judge’s interim order stopped the implementation of three sections of the new Anti-Counterfeit Act.
The Act was enacted by Parliament in 2008 and President Kibaki assented to it on December 24, same year. Its objective was to prohibit trade in counterfeit goods. It was to take effect from July 7, 2009.
Omwanza told the court people using ARV drugs would be arbitrarily denied access to affordable and essential medication necessary for their fulfillment of the right to life as enshrined in the Constitution.
"The generic drugs for the treatment of HIV and Aids are available and affordable compared to the branded version," he argued.
Attorney General Amos Wako said the Act was established to stop multinationals from importing counterfeit drugs.
In an affidavit filed by an NGO’s official Jacinta Nyachae, the cost of ARVs will be high if the Act was enforced.
Source: The Standard Online Edition
Tuesday, January 18, 2011
Thursday, July 29, 2010
Kenya’s proposed new constitution and access to medicine
By Judy Wahito Ndegwa, HAI Africa intern
As Kenyans prepare to vote in the referendum on the proposed new constitution (PNC) on August 4, never have two colours meant so much in this country. The ayes (in support of the constitution) are green while the nays, who oppose the draft law, are red. For people working on access to medicines issues the question is: is the PNC green or red on access to essential medicines?
The PNC is one of the most voluminous constitutions in the world. Anything considered significant to the past, present and future of this country has been captured. The right to health being of importance has not been left out.
The right to access essential medicines is premised on the right to health. This has been recognized under the head of economic and social rights at article 43 (1) (a) which provides that every person has the right— (a) to the highest attainable standard of health, which includes the right to health care services, including reproductive health care. This is a step forward as presently for one to bring out the right to health, one has to broadly interpret the right to life or refer to international instruments.
in fact, In the court case filed to challenge the Kenya Anti-Counterfeit Act of 2008, the petitioners have asked the court to interpret the right to life as encompassing the right to access essential medicines. Had the petition been brought under the proposed draft, framing the issues would have been much easier.
The right to health for children has also been captured under article 53 paragraph (1) (c) which provides that every child has the right to basic nutrition, shelter and health care.
The right to health like all other economic and social rights will be progressively realized. Article 21(2) requires the State to take legislative, policy and other measures, including the setting of standards, to achieve the progressive realization of the rights guaranteed under article 43.
To prevent the state from using the provisions on progressive realization as an escape, article 20(5) provides that in applying any right under Article 43, if the State claims that it does not have the resources to implement the right, a court, tribunal or other authority shall be guided by the following principles––
(a) it is the responsibility of the State to show that the resources are not available;
(b) in allocating resources, the State shall give priority to ensuring the widest possible enjoyment of the right or fundamental freedom having regard to prevailing circumstances, including the vulnerability of particular groups or individuals;
These provisions are however watered down by the provisions of paragraph (c) which provides that the court, tribunal or other authority may not interfere with a decision by a State organ concerning the allocation of available resources, solely on the basis that it would have reached a different conclusion. This would mean that an improper decision by the state regarding health rights may fail to be challenged by the court!
Another positive provision is Article 46 paragraph (c) subsection (1) which provides that consumers have the right to the protection of their health, safety, and economic interests. With regard to medicines, this provision may be argued to capture the issues of quality, safety and efficacy in medicines. One may also argue that the issue of affordable medicines may fall under the term ‘economic interests’ of the consumer. As such, a consumer may successfully challenge over pricing of medicines or measures that would have an adverse effect on the price of medicines.
On a score card, the draft constitution’s protection of health rights and consequently the right to access essential medicines, scores highly.
Shortfall in the proposed constitution in safeguarding the right to health
This said however, one issue keeps gnawing at my optimism. ‘The international law clause’. Captured under articles 2(5) and 2(6).. Article 2(5) provides that the general rules of international law shall form part of the law of Kenya . On the other hand, article 2(6) provides that any treaty or convention ratified by Kenya shall form part of the law of Kenya under the Constitution.
The net effect of these provisions is that once a treaty or agreement has been ratified (formal approval by an executive authority), it becomes part of our national laws. The treaty or convention not only becomes part of Kenyan law, but attains constitutional status due to the words ‘under this constitution’ which means within the constitution. This is contrary to the current status in Kenya where a ratified treaty or convention has to be ‘domesticated’ through an Act of parliament for it to apply as part of national legislation.
The advantage of the current status is that the provisions of the ratified treaty are scrutinized by parliament before enactment. It also gains legitimacy among the people as it is approved by their democratically elected representatives. Further, it provides an opportunity for individuals or members of the civil society to give their views on the proposed law.
The proposed method under the PNC is therefore less democratic and more precarious. With impeding international treaties such as ACTA (the Anti-Counterfeiting Trade Agreement) which propose measures that could potentially inhibit access to essential medicines, such a move is to say the least, risky.
Notably article 2(6) refers to ‘any treaty or convention’. This therefore refers to even the East African Community (EAC) treaty which provides that members should enact laws that enable the community laws to gain supremacy over their national laws. If the PNC passes, Kenya will have met this requirement.
Once again one must bear in mind that there is an EAC Anti-Counterfeit Bill which also threatens to limit access to essential medicines and one which has been widely opposed by health and Intellectual Property law experts at all levels..
Article 2(6) is therefore a dangerous provision as it makes Kenya vulnerable to conventions and treaties which may not be in the best interest of the country bearing in mind that Kenya is a developing country which heavily relies on external partners for funding. It is, therefore, possible for such partners to arm twist the government into entering into agreements that may not be in the interest of the country.
In light of the above, is the PNC green or red with regard to access to essential medicines? Be the judge!
As Kenyans prepare to vote in the referendum on the proposed new constitution (PNC) on August 4, never have two colours meant so much in this country. The ayes (in support of the constitution) are green while the nays, who oppose the draft law, are red. For people working on access to medicines issues the question is: is the PNC green or red on access to essential medicines?
The PNC is one of the most voluminous constitutions in the world. Anything considered significant to the past, present and future of this country has been captured. The right to health being of importance has not been left out.
The right to access essential medicines is premised on the right to health. This has been recognized under the head of economic and social rights at article 43 (1) (a) which provides that every person has the right— (a) to the highest attainable standard of health, which includes the right to health care services, including reproductive health care. This is a step forward as presently for one to bring out the right to health, one has to broadly interpret the right to life or refer to international instruments.
in fact, In the court case filed to challenge the Kenya Anti-Counterfeit Act of 2008, the petitioners have asked the court to interpret the right to life as encompassing the right to access essential medicines. Had the petition been brought under the proposed draft, framing the issues would have been much easier.
The right to health for children has also been captured under article 53 paragraph (1) (c) which provides that every child has the right to basic nutrition, shelter and health care.
The right to health like all other economic and social rights will be progressively realized. Article 21(2) requires the State to take legislative, policy and other measures, including the setting of standards, to achieve the progressive realization of the rights guaranteed under article 43.
To prevent the state from using the provisions on progressive realization as an escape, article 20(5) provides that in applying any right under Article 43, if the State claims that it does not have the resources to implement the right, a court, tribunal or other authority shall be guided by the following principles––
(a) it is the responsibility of the State to show that the resources are not available;
(b) in allocating resources, the State shall give priority to ensuring the widest possible enjoyment of the right or fundamental freedom having regard to prevailing circumstances, including the vulnerability of particular groups or individuals;
These provisions are however watered down by the provisions of paragraph (c) which provides that the court, tribunal or other authority may not interfere with a decision by a State organ concerning the allocation of available resources, solely on the basis that it would have reached a different conclusion. This would mean that an improper decision by the state regarding health rights may fail to be challenged by the court!
Another positive provision is Article 46 paragraph (c) subsection (1) which provides that consumers have the right to the protection of their health, safety, and economic interests. With regard to medicines, this provision may be argued to capture the issues of quality, safety and efficacy in medicines. One may also argue that the issue of affordable medicines may fall under the term ‘economic interests’ of the consumer. As such, a consumer may successfully challenge over pricing of medicines or measures that would have an adverse effect on the price of medicines.
On a score card, the draft constitution’s protection of health rights and consequently the right to access essential medicines, scores highly.
Shortfall in the proposed constitution in safeguarding the right to health
This said however, one issue keeps gnawing at my optimism. ‘The international law clause’. Captured under articles 2(5) and 2(6).. Article 2(5) provides that the general rules of international law shall form part of the law of Kenya . On the other hand, article 2(6) provides that any treaty or convention ratified by Kenya shall form part of the law of Kenya under the Constitution.
The net effect of these provisions is that once a treaty or agreement has been ratified (formal approval by an executive authority), it becomes part of our national laws. The treaty or convention not only becomes part of Kenyan law, but attains constitutional status due to the words ‘under this constitution’ which means within the constitution. This is contrary to the current status in Kenya where a ratified treaty or convention has to be ‘domesticated’ through an Act of parliament for it to apply as part of national legislation.
The advantage of the current status is that the provisions of the ratified treaty are scrutinized by parliament before enactment. It also gains legitimacy among the people as it is approved by their democratically elected representatives. Further, it provides an opportunity for individuals or members of the civil society to give their views on the proposed law.
The proposed method under the PNC is therefore less democratic and more precarious. With impeding international treaties such as ACTA (the Anti-Counterfeiting Trade Agreement) which propose measures that could potentially inhibit access to essential medicines, such a move is to say the least, risky.
Notably article 2(6) refers to ‘any treaty or convention’. This therefore refers to even the East African Community (EAC) treaty which provides that members should enact laws that enable the community laws to gain supremacy over their national laws. If the PNC passes, Kenya will have met this requirement.
Once again one must bear in mind that there is an EAC Anti-Counterfeit Bill which also threatens to limit access to essential medicines and one which has been widely opposed by health and Intellectual Property law experts at all levels..
Article 2(6) is therefore a dangerous provision as it makes Kenya vulnerable to conventions and treaties which may not be in the best interest of the country bearing in mind that Kenya is a developing country which heavily relies on external partners for funding. It is, therefore, possible for such partners to arm twist the government into entering into agreements that may not be in the interest of the country.
In light of the above, is the PNC green or red with regard to access to essential medicines? Be the judge!
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.
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.
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.
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.
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