What kind of Provisions regulate the Access to ARV Medicine and how did Thailand react?

Table of Contents

I. Introduction

II. Provisions that regulate the Access to ARVs
The TRIPS Agreement
Compulsory licensing
Voluntary licensing
Parallel importing
TRIPS Plus “TRIPS Plus is going even further than TRIPS” (MSF, 2011).

Which provision has been applied? Case study Thailand - granting a compulsory license

Conclusion

List of References

I. Introduction

The Human Immunodeficiency Virus, short called HIV, targets the human immune system and weakens the surveillance and defense system against infections. Infected people become gradually immunodeficient, while the virus destroys and impairs the function of immune cells. The Immune function is typically measured by the CD4 cell count. The most advanced stage of HIV is the Acquired Immunodeficiency Syndrome (AIDS).

HIV is a major public health issue, since it is the “world’s most leading infectious killer“ (WHO, 2014). Until today, no cure for HIV was found, but treatment with antiretroviral (ARV) drugs can help to control the virus. In a standard antiretroviral therapy (ART) are at least three antiretroviral drugs combatant to suppress the HIV virus and stop the progression of the disease.^[1] In 2013 around 12.9 million people are receiving ART globally, of which 11.7 million were in low- and middle-income countries.

In 2010 the United Nations agreed to achieve a coverage of 15 million people on treatment worldwide by 2015 (United Nations, 2011) and most countries are aspiring to expand treatment access to around 80 percent of those in need, but this target has not been met on a global scale since the current coverage is at 65 percent.

Although it is well tried to achieve universal access to ARV drugs various trade laws make it harder to prevent everybody in need with medication. Further on, the behaviour of pharmaceutical companies play a big role for the access of ARVs.

It is to be said that I am going to focus my work on the TRIPS Agreement which was established in 1995, the trips agreement as 5 broader issues but I am going to concentrate on the protection of intellectual property rights, since this issue affects the access to HIV medication world wide. and the role of generic drugs. Ongoing, I will show off how Thailand reacted regarding TRIPS and how they used the flexibilities of it.

II. Provisions that regulate the Access to ARVs

The TRIPS Agreement

The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) sets the guideline to protect intellectual property worldwide, nowadays. It took in place on January, 1st 1995 and ties all members of the World Trade Organization^[2] (WTO).

TRIPS sets a minimum standard of protection for intellectual property rights including patents, copyright, trademarks and industrialized designs (including medicine) it is enforced through the national legislation. These standards include that the protection of a patent was given at a minimum of 20 years beginning from the registration date. The patents can be given to products and processes. The question what is rather be protected by a patent is determined by the countries. The TRIPS Agreement does not define terms, like deciding whether a new combination (two ore more molecules are getting combined in one pill) or a new formulation (producing a pill version of a drug that once came as a powder) justifies for a twenty-year patent. These two terms a a privilege for the countries to decide because they are not determined by the WTO texts. Having that in mind, countries should determine what deserves a pharmaceutical patent, knowing there own economic and social situations^[3] (MSF, 2011). It is also agreed in the TRIPS Agreement that transitional periodsare necessary for states to react and prepare. Industrialized countries got one year to implement TRIPS (until 1996) while developing countries got five years ( until 2000) and least developed countries were given eleven years (until 2006). During the term of a patent the ‘Bolar exemption’ applies.

Bolar exemption: In the TRIPS Article 30 is a limited exceptions to the rights commissioned to the patent holder. The most common exception to exclusive rights of the patent holder in the pharmaceutical context is referred as the ‘ Bolar provision ^[4] / Bolar exemption ’ . The ‘ Bolar exemption ’ allows interested (mainly generic) manufacturers to research and develop a new product before the patent expires. This is important regarding the submission of information and samples to the regristration authorities. The purpose behind this is to get an approval of the generic drug before the patents expiration date to ensure that a generic drug can come onto the market shortly. (Nana K. Poku, Alan Vhiteside & Bjorg Sandkjaer, 2007 : 202)

Originally TRIPS was claimed to simulate the transfer of technology, to encourage foreign investments and to strengthen the research and development of new innovations, especially in least developed countries. Since the TRIPS agreement has a huge impact on generic drug production and controls in some ways the drug prices and tariffs and duties some analysts argued that TRIPS would decrease the health care system and strengthen monopolies. “The balance between the private interests of the patent holder and the larger interests of society is severely skewed” (MSF, 2011).

In 2001, at the annual conference of the WTO in Doha, the countries recognized the gravity of the imbalance regarding public health problems especially in developing and least developed countries. The Doha Declaration advocates countries rights to use TRIPS sponsorships like compulsory licenses or parallel impression to avoid patent barriers and promote access to medicine. A huge achievement of the meeting was to extend the transition period for least developed countries to another ten years (from 2006 to 2016). Especially the US supported by the EU, Japan, Switzerland and Canada^[5] intended on preserving the protection of intellectual property rights, while Brazil and India^[6] tried to strength the health safeguards. In the end the WTO agreed that:

“The TRIPS Agreement does not and should not prevent members from taking measures to protect public health”^[7] (WHO, n.d.).

It has a few provisions under it, they can be used to avoid high drug prices charged by patent owners but it is each country can decide by themselves wether or not they want to convert those safeguards into their national law or not. Those provisions are the compulsory license, voluntary license and parallel imports. I will explain all three of them more in the following.

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^[1] A person should go under ART with a CD4 count less than 350 cells/mm3

^[2] The WTO was established in 1995, it followed from the Uruguay Round and superseded GATT as an international Organization. Currently there are 160 members of the WTO of which 117 are developing countries ore separate customs. It is the umbrella organization of GATT,GATS and TRIPS. There main aim is to reduce trade barriers, liberalist the international trade and to protect customers and prevent the spread of diseases (WTO, 2013)

^[3] A few governments like Brazil, India and Thailand have done that. (MSF, 2011)

^[4] The name refers to a court case in the US, “Roche Products Inc. vs. Bolar Pharmaceutical Co. which dealt with this type of exception. (Jakarta, 2000)

^[5] all of them are developed countries

^[6] both are least developed countries

^[7] §§ 4-6