The Patient Is More Important Than The Patent

By patience Akumu

21 September 2011

 ‘Production of quality affordable generic medicines is key in access to life saving /life-extending treatments for people who need it, and narrow national economic interests should not take precedence over a global commitment to save lives of People Living With HIV (PLHIV)…’. This message was brought out clearly at the recently concluded 10th International Congress on AIDS in Asia and the Pacific (10th ICAAP), held in Busan, Korea.

 The discounted price for life saving first line AIDS treatment has been brought down from the 2000 whopping price of $10,000 per person per year to the current $60, thanks to the Indian generic drug manufacturing companies. But Europe and other developed countries are pursuing aggressive trade policies that are likely to reverse the process. The European Union (EU) is negotiating with India, Thailand, Indonesia, Philippines, and the US is involved in talks on Trans Pacific Partnership Agreements with Australia, Malaysia, New Zealand, Singapore, and Vietnam.  These Free Trade Agreements (FTA) demand higher level of Intellectual Property protection expanding monopolies of multinational pharmaceutical companies and threaten the ability of countries to manufacture or import ARV generic medicines, thus restricting access to life saving medicines to millions of people in the developing world. To add insult to injury, the recent alarming spate of buy offs by multinational companies of Indian firms manufacturing generic medicines, is likely to push up drug prices manifold in the Indian market in the near future.

 At a session organized at the 10th ICAAP, by Medicins Sans Frontieres (MSF), Kajal Bhardwaj, Independent Legal Researcher on HIV, health and human rights from India informed that “India is a key drug supplier to the world with 92% of patients on ARVs in low- and middle-income countries using generic drugs coming mostly from India. Also 67 % of medicines exports from India go to developing countries, and 75-80% of all medicines distributed by the International Dispensary Association are manufactured in India. However, in its FTA with India, EU is asking for strong Intellectual Property Protection which could stop the flow of affordable and life-saving medicines for millions of patients in developing countries.”

 Kajal further added: “As of now, every member country of the World Trade Organization has to implement the agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS), which requires countries to grant 20 year patents on medicines, but it is up to countries to decide whether they will have strict standards or not in granting patents, thus prohibiting evergreening—a practice of pharmaceutical companies of making small changes to old medicines to extend patent life. But developed countries are now demanding inclusion of ever-greening of patents and  TRIPS+ (data exclusivity) provisions in which one may have to give patent for longer than 20 years (patent term extension) . Contrary to TRIPS requirement of only data protection, data exclusivity (DE) mandates that the generic cannot rely on the originator’s clinical trial results for 5-11 years and would have to repeat the clinical trials if it wants to be approved in the DE period, or wait for 5-11 years before it can be registered and reach patients.”

The impact of DE has been devastating in countries like (i) Jordan where data exclusivity has delayed the introduction of cheaper generic versions of 79% of medicines even though there is no patent on them, and over 25% of the Ministry of Health’s budget is now spent on buying medicines; (ii) Colombia which would require an extra US$1.5billion to be spent on medicines every year by 2030. If this is not spent, Colombians will have to reduce their medicine consumption by 44% by 2030; (iii) Guatemala where there have been price differences of up to 845000% in the same therapeutic class of medicines.

 According to a Korean study, the extension of patent term is likely to cost the Korean National Health Insurance Corporation US $529m for extending drug patents for 3 years and US $757m if it has to agree to a 4 yr extension as proposed under the FTA negotiations with the United States.

 John Rock, adviser with APN + (Asia Pacific Network of People Living with HIV/AIDS) voiced his concern at the Community Forum– “the community is concerned about the free trade agreement (FTA) currently under negotiation between India and European Union, which threatens the production of generic medicines which will among others affect HIV patients. The EU-India draft FTA, as it stands, places trade interests over human rights, there is an immediate need for global action to ensure affordable access to treatment.”

 The Inter Faith pre-conference participants also agreed that ‘Universal access to prevention, treatment, care and support are also being influenced by unjust trade agreements. Life saving medication and diagnostic procedures should not be at the mercy of   pharmaceutical companies particularly in the knowledge that ARVs are effective in preventing HIV transmission.   Intellectual property rights regimes need to address the survival needs of people who are affected and infected by life threatening diseases.

  Dr JVR Prasada Rao, senior adviser to UNAIDS Executive Director exhorted the developed countries not to bind developing economies to inflexible TRIPS provisions which are counterproductive to Universal access for PLHIV.

 He agreed that “FTA TRIPS agreements and their actual operation at country level have become serious impediments to affordable HIV/AIDS treatment. Added to this is the new slogan of anti-counterfeiting, which confuses generic drugs with counterfeit medicines of spurious quality. On one side we say that millions of PLHIV need to be provided with affordable treatment, while on the other side we throttle supply of good quality but cheap generic drugs.”

 The UN special rapportuer on health has also agreed that “As FTAs can directly affect access to medicines, there is a need for countries to assess multilateral and bilateral trade agreements for potential health violations and all stages of negotiations should remain open and transparent. International negotiations on issues related to intellectual property rights and health should be coherent in their approaches to the promotion of public health.”

 Let us not forget the spirit of the Doha Declaration which states that “We affirm that the (TRIPS) Agreement can and should be interpreted and implemented in a manner supportive of WTO Members’ right to protect public health and, in particular, to promote access to medicines for all.” (CNS)

Source: The Observer

Is Uganda still considered an HIV/Aids success story?

By Primah Kwagala

October 13, 2011

Uganda is often used as a model for Africa in the fight against HIV and AIDS. There are an estimated 1.2 million people living with HIV in Uganda, which includes 150,000 children.

An estimated 64,000 people died from AIDS in 2009 and 1.2 million children have been orphaned by this devastating epidemic. The number of new infections (an estimated 120,000 in 2009) exceeds the number of annual AIDS deaths (64,000 in 2009), and it is feared that the HIV prevalence in Uganda may be rising again. There are many theories as to why this may be happening, including the government’s shift towards abstinence-only prevention programmes, and a general complacency or ‘AIDS-fatigue’.

It has been suggested that antiretroviral drugs have changed the perception of AIDS from a death sentence to a treatable, manageable disease. This may have reduced the fear surrounding HIV, and in turn have led to an increase in risky behaviour.

In Uganda today, not everyone who needs ARVs has access to them. The whole management of ARVs has been and still remains a paradox to treatment providers. While access to ARVs has increased lately, mainly due to price reductions led by increased importation of generics into the country, the greater majority of Ugandans who still need the therapy cannot afford it. Yet the government can only afford to support only a third of the larger group that needs these medicines.

It is generally agreed that legislation and international agreements are some of the main causes of difficulty in accessing these life saving medicines. Uganda like so many other countries is a member of the World Trade Organization and thus carries a mandate under the TRIPS (Trade Related Aspects of Intellectual Property) Agreement to protect all sorts of intellectual property including pharmaceuticals. In a bid to comply with this agreement the Law Reform Commission drafted the Industrial Properties’ Bill and Anti- Counterfeit Bill. These have been forwarded to parliament. However, critics of the bills say the bills are confusing and the terms used in them need further clarification in order to exploit the advantages brought forth by the Doha Declaration on Public health.

It has been proposed by NGOs working on access to medicines that Uganda should not hurry to implement its obligations in the TRIPS but rather learn from the best practices of other countries like Rwanda, which already has an exemplary law regarding protection and enforcement of intellectual property laws.

In addition, Uganda is under no obligation to patent pharmaceutical products until 2016, as per the Declaration on the TRIPS agreement and Public Health (Doha Declaration). The proposed Industrial Properties Bill, however, does not provide for this extension. The Bill further does not take advantage of certain safeguards and provisions of the Doha Declaration. It is thus significantly more stringent in some cases than even TRIPS, and it has more often than not been recommended that some of these stringent provisions be revised to suit the needs of ordinary Ugandans.

The other concern has been regarding some of the definitions in both the Anti- Counterfeiting Bill and the Industrial Properties Bill. For instance, “counterfeits” have been defined to mean all goods that are “substantially similar“ to the originator product. What critics say is that counterfeits should be limited to trade mark and copyright infringement and exclude pharmaceuticals. This is because Uganda depends on mainly generic drugs. In fact it is said that almost 90 percent of Uganda’s imported drugs are from generic producers, if they defined generic medicines as “counterfeits” then poor people who cannot even earn a dollar a day will not be able to afford these life saving therapies. What the government needs to do is invest some more money in persons drafting these legislations to consider best practices in countries like Rwanda to inform our laws.

Further, it is important that Uganda takes advantage of the Doha Declaration and its parallel decision regarding Paragraph Six of the declaration. This requires a number of steps, among which include: 1) in most cases, compulsory licenses issued by importing and exporting countries, 2) the importing country’s establishment of insufficient or no local manufacturing capacity in the specified pharmaceutical sector, 3) importer notification to the WTO of its intention to use the system detailing product(s) requested and quantities (accompanied by confirmation of insufficient manufacturing capacity and that a compulsory license is or will be granted), and 4) notification of the exporting country’s compulsory license to the WTO and the conditions attached.

It should also be noted that parallel imports are also of particular importance in meeting public health needs since the pharmaceutical industry generally sets differential prices globally for the same medicine. Thus, parallel importation of a patented medicine from a country where it is sold at a lower price, will enable more patients in the importing country to gain access to cheaper drugs. Paragraph 5(d) of the declaration explicitly reaffirms members’ freedom to determine their own regimes for the exhaustion of intellectual property rights without challenge.

The TRIPS Agreement further has several provisions, which deal explicitly with the issue of technology transfer. For instance, Article 7 states, to the effect that protection and enforcement of intellectual property rights should contribute to technological innovation and to transfer and disseminate technology, to the mutual advantage of producers and users of technological knowledge and in a manner conducive to social and economic welfare and to a balance of rights and obligations. Despite such provisions, little technology transfer to Uganda has taken place. In order to strengthen local industry, Uganda ought to still chase initiatives to absorb new technology. Public-private partnerships (PPPs) may be one mechanism to achieve this. Generally, PPPs require private sector companies to provide the technology and expertise while public sector partners provide development funding and help ensure access to the medications.

One of the major setbacks of TRIPS is to oblige all countries, rich and poor, to grant at least 20 years patent protection for new medicines, thereby delaying production of the inexpensive generic substitutes upon which developing-country health services and poor people depend. It is therefore important that Uganda makes and puts these laws in place to safeguard public health issues of access to medicines. Latest research reports have shown that using treatment as a prevention strategy could actually bring the HIV/AIDS scourge to an end, investing in treating everyone should be priority as reports have it that Rwanda is acting on these research findings. Government of Uganda is urged to invest more in enabling its citizenry to access ARVs.

Source: KC team

Drugs, patents and poor people

 Christa Cepuch, a pharmacist and health rights activist, has no doubt about the issue: essential medicines are basic and should be readily accessible at an affordable price.

But the reality is different as Min Abbo’s story illustrates. Min Abbo, 60, almost lost her life when she was afflicted with a severe bout of diarrhoea and vomiting. Her daughter, Miliosi Abbo, was contacted by relatives in the village that her mother was very sick and likely to pass on any time.

 She had been hanging precariously between life and death for three weeks. Miliosi asked for time off from her housemaid job in Kampala to check on her mother in Tororo district. But she was shocked when she got there: her mother looked like an eight-year-old child.

 Min Abbo could not afford the Shs 2,000 needed for the journey to the nearest health centre, not to mention the Shs 15, 000 the health centre would ask for before she’s treated.

 High prices

Accessing drugs such as those that treat diarrhoea is integral to the World Health Organisation’s mission. The organisation wants to see that essential medicines are easily available. Yet, only a fraction of people living in Low Developed Countries (LDCs) are able to access medicines.

 And while they are very poor, these countries buy the medicines expensively. For instance, a world medicine price index reveals that prices in Uganda are three to five times higher than international prices. This means that on average, 55% of Uganda’s household expenditures are on medicine – a big percentage considering that most live in poverty.

 Cepuch notes that even though Uganda’s health budget was increased from Shs 101bn in the 2010/2011 to Shs 204bn in 2011/2012, this only translates into Shs 6,000 for each of the 33 million Ugandans per year.

The amount, according to the budget framework paper, is set to increase to Shs 280bn in three years. But while the government has demonstrated some commitment to health, Cepuch observes that the high population growth and inflation rates negate such efforts.


Pharmaceutical companies protect monopoly over their medicines through a complex regime of patents. Once these patents are registered, newly invented medicines are protected for 20 years.

Uganda is party to the Trade Related Aspects of Intellectual Property Rights Agreement (TRIPS) – a piece of international legislation governing intellectual property, which includes innovations such as new medicines.

 The inventors are given monopoly as patent holders and no one can manufacture the same drug until the patent expires. Yet, these patented drugs are often sold at astronomical prices only a few rich countries and individuals can afford.

 The TRIPS, however, has flexibilities developing countries can take advantage of to ensure that patent holders are not protected at the expense of human life. For example, LDCs, with respect to medicines, do not have to comply with the patents until 2016.

 This is meant to give them a chance to develop their pharmaceutical industry. In cases of extreme emergency, national urgency and under other circumstances, or for the protection of public health, a government may issue a compulsory licence to other manufactures to make medicines without the consent of the patent holder.

 Alternatively, such medicines can be imported from countries where the patent holder’s rights do not apply and the same medicine is sold cheaper.

 Generic drugs

Countries like Brazil, China and India are trail blazers in the manufacture of generic drugs. Cepuch explains that generics are exactly the same as the originator drugs manufactured by patent holders and they work in the exact same way and have the exact same effect.

 However, the public often insists on the more expensive originator drug. For example, Hajji Mustafa Kakaire whose wife is suffering from cancer says he would never allow her to take drugs from India. Rather, he insists that she takes medicine from Germany. He refers to the drugs from India as “fake.”

 Yet most drugs in the country are generic. ARV prices fell dramatically from what they were in the 1980s because of generic manufactures. The public mistakes generic medicines to mean the same thing as counterfeit and/or substandard.

 Cepuch acknowledges that these terms are “confusing and meant to confuse.” She explains that generic drugs are not substandard or counterfeit. Substandard refers to drugs that may be legally on the market but are of poor quality due to factors like poor handling, storage or manufacturing errors, while counterfeit refer to drugs illegally on the market or those that infringe on patents.

 While counterfeit and substandard drugs pause dangers, generic drugs are safe.

Ray of hope

In Uganda, Quality Chemicals Industry in Luzira, locally manufactures generic drugs, shining a ray of hope on the ailing pharmaceutical industry in LDCs. The only one of its kind in East Africa, George Baguma, director of marketing, says they aim at producing quality affordable medicines for the local people.

 Thus, he says, the ideal retail price for Coartem, a malaria drug which they manufacture and whose active ingredients are available locally, should be Shs 2,000. The drug is sold at Shs 800 to wholesalers.

 But in pharmacies around Kampala, a dose of Coartem from Quality Chemicals goes for Shs 10,000. Originator Coartem from Switzerland is about Shs 18,000. Baguma emphasizes that at public health facilities, these drugs should be given out free.

 Florence Nakachwa, assistant registrar at the Uganda National Drug Authority, says they are mandated to ensure that medicines on the market are available, genuine and safe.

 They, however, do not have control over the market prices. In fact there is currently nobody that regulates these prices. Pharmacies and medical units take advantage of Uganda’s liaisez faire trade policies to price the drugs as they please.

Health workers coverage stuck at 56% countrywide

By Juliet Kigongo

The proportion of trained health workers across the country has stagnated at 56 per cent for the last two years, a situation that has affected the efficiency of the sector, the health minister has said.

Dr Christine Ondoa, while speaking at the eighth National Health Assembly and 17th Joint Review Mission in Kampala yesterday, said:” Efforts to ensure attainment and maintenance of an adequate, equitably distributed and appropriately skilled workforce were hampered by recruitment as a result of a limited wage bill.”

The health minister said support is needed from Parliament to increase funding for recruitment of health workers to fill the gaps in district hospitals. “This is on top of the Shs2.2 billion we allocated for contracting graduate interns. Discussions are also on-going to decentralise health workers, which will be advantageous as far as recruitment, supervision, mentoring and discipline of the health workers is concerned,” Dr Ondoa said.

According to the minister, the Health Sector Strategic and Investment Plan report for the financial year 2010/11 had varied performance in the health services coverage.


She noted that the proportion of households living within walking distances to health facilities is currently estimated at 72 per cent. Adding that availability of medicines and health supplies in health facilities has also improved by almost 70 per cent due to adherence to delivery schedules and an increased funding.

Dr Ondoa cited improving the image of the health sector, efficiency, supervision and monitoring as well as funding as the ministry’s focus to better service delivery.

Government wants maternal health case dismissed

In what could be seen as a U-turn by government on its promise to prosecute health workers who allegedly neglected pregnant mothers resulting in death at various hospitals, the State on Thursday asked the Constitutional Court to dismiss a petition of the aggrieved families.

Two people; Ms Rhoda Kukkiriza and Valente Inziku from Mityana and Arua districts respectively took government to court seeking for a declaration that the the State must abide by its promise to address shortages of doctors and midwives, drug stock-outs as well as the absence of emergency transport that results in the death of 16 women everyday.

The families in the maiden health service petition brought jointly with Centre for Health, Human Rights and Development and Makerere University don Ben Twinomugisha, are seeking a declaration that the acts and omissions by medical workers contravene the Constitution.

But Principal State Attorney Patricia Mutesi argued that a court determination would amount to usurping of power of the Executive and the Parliament to determine on the economic policies.
“The issues raised in the petition do have judicial standards for court to determine that there are no sufficient resources. If court was to base the performance of Uganda to other countries, it is not proper because there is no standard that court can use to determine its findings,” said Ms Mutesi.

“The issues framed in the petition raise political questions thereby prohibiting court from making decisions,” Ms Mutesi added.

However, Mr David Kabanda, the petitioners’ attorney, said the State objection was misconceived because the matter before court is seeking for court interpretation whether the acts and omissions at the various health centres contravene the Constitution.

“Government cannot run away from its obligations of providing maternal health yet it is a signatory to many United Nations (UN) conventions. It is about telling government to abide by the promises to provide effective health services,” Mr Kabanda said.

According to the petition, the manner in which the hospitals and their staff are managed leaves a lot to be desired and cannot ensure the enjoyment of the highest attainable standard of physical and mental health and it has led to rampant avoidable maternal and infant mortality which contravene the provisions of the law.

“That the unacceptable higher maternal deaths in Uganda which are due to government’s non-provision of basic minimum maternal health care packages and the non-attendance and improper handling by the health workers to expectant mothers are unconstitutional,” reads part of the petition.

Several women have died due to lack of money to buy simple birth kits as health centre managers claim the government does not provide enough material to cater for maternal health.