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World Intellectual Property Day: Are women in Uganda being priced out of life-saving medicine due to Intellectual Property Rights?

On this 26th day of April 2018, Uganda joins the rest of the world in commemorating World Intellectual Property day under the theme “Powering Change: Women in Innovation and Creativity” However, as we shine the light on women in innovation, the fundamental question is: are women who are the most affected group with the HIV scourge in Uganda and other developing countries benefiting from medical inventions that they so need?

 

Intellectual Property (IP) refers to creations of the mind, which include inventions, literary and artistic works, symbols, names, images, and designs used in trade. Intellectual Property creates rights that give entitlement to owners of IP in form of patents, copy rights and trademarks among others. These rights give the inventor the legal protection from competition so they can use or benefit from their creation exclusively for a specified period of time.

Although IP Rights are intended to promote innovation and creativity, they act as barriers for access to essential medicines as they create monopolies for pharmaceutical manufacturers who charge exorbitant prices, thereby making these medicines out of reach for many especially in least developed countries.

The sad reality is; over one quarter of the world’s population could be left at the mercy of their ailment, unable to access medicine that could change the course of their lives and this is daunting for anyone that believes in social justice. It is not surprising that IP is at the center of global debates with advocates of human rights arguing that strict enforcement of Intellectual Property Rights (IPR) affects the realization of the right to health which is recognized in international instruments and national constitutions of various countries around the world including Uganda. The International Covenant of the Economic Cultural and Social Rights (ICESCR) for instance provides that “everyone has a right to enjoyment of the highest attainable standards of physical and mental health[1]” defined to include access to essential medicines.

According to the health data of 2016 compiled by the Institute for Health Metrics and Evaluation[2], HIV was ranked number one cause for premature death in Uganda. Moreover women, in particular, are disproportionately affected in comparison to men. The health data indicates that in 2016 the HIV prevalence rates of women living with HIV was 7.6% as compared to men 4.7%. Although the first line drugs have become more affordable in the recent times, the increasing drug-resistance still presents a challenge in developing countries since patients must be moved to the second line medicines and newer formulas which are likely still protected by patents. Medicines under patent protection are evidently expensive since the inventors must make a return on the high costs of research and development.

The solution however lies in the effective utilization of provisions incorporated in the WTO- Trade Related Aspects of Intellectual Property Agreement now commonly referred to as the TRIPS flexibilities. Some key flexibilities include compulsory licensing which allows third parties to use an invention without the holders’ consent and parallel importation which allows procurement of drugs at a lower price from another country without consent of a patent holder of a patented product that is on the market of the exporting country. Another significant flexibility is the exemption of least developed countries from enforcing pharmaceutical patents until 2033 which should be exploited to promote transfer of technology.

The problem is that there little to no evidence which indicates utilization of these provisions by the developing countries including Uganda to promote access to essential medicines especially for people living with HIV, women being the majority.

As we celebrate women in innovation today, we must think of those women who are unable to access essential medicines due to a high cost implication caused by the strict enforcement of Intellectual Property Rights.


[1]Article 12 (1) of ICESCR

[2]Available at www.healthdata.org

Eala reviews key EAC integration laws

By John Oyuke

East African Legislative Assembly (Eala) has passed two key legislative amendments to strengthen regional integration.

The legislators, whose five-year term ends on June 4, and currently meeting in Nairobi, debated and passed the Customs Management Act (Amendment) Bill 2011, and the Community Emblems Act (Amendment) Bill 2012 on Wednesday.

The Customs Management Act (Amendment) Bill 2011, which sailed through after intense debate modifies the initial Customs Management Act 2004. It comprises a new section providing for the prevention and suppression of money laundering, drugs and arms trafficking and infringement of intellectual property rights.

The Chairperson of the Council of Ministers, Musa Sirma, said the Bill hopes to fill a vacuum left out by the original Bill and proposes joint engagement in fighting transnational crimes in the region. The East African Legislative Assembly Plenary, which started on Monday and runs through to April 26, is also expected to pass several other Bills, including HIV/Aids and conflict resolution before its term expires.

Eala Member Dora Byamukama noted that all partner states had appended their signatures to the international conventions against human trafficking and transnational organised crimes and the Assembly was therefore duty bound to pass the new Bill.

Reacting to the new development, Assistant Minister for Kenya’s East Africa Community ministry, Peter Munya, said the establishment of a single Customs Authority was well underway.

“We do expect the forthcoming Summit of the EAC Heads of State next week shall consider the roadmap and pronounce itself on the matter,” he said.

Members went through the Bill to generate heated discussions as to whether cross-border crimes such as human trafficking were part and parcel of customs issues and if so, the correlation and complementarity with the existing laws and Protocols.

Source: http://www.standardmedia.co.ke/InsidePage.php?id=2000056691&cid=14&j=&m=&d=

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

http://www.observer.ug/index.php?option=com_content&task=view&id=15138&Itemid=68