Good Example Of Research Proposal On Compulsory Licenses

The protection of intellectual property rights for invention in the field of public health care was one of the most controversial issues within the WTO system. It concerns mainly developing and least developed countries. On the one hand, each member-state should ensure adequate protection of IP rights, as well as required reward to the respective patent holder. On the other hand, essential medicines should be affordable for the population as well as they should be available to manage public health crisis, if any. This is where the interests of the big western pharmaceutical companies and the government of developing and least developed WTO members contradict. Introducing the TRIPS Agreement in 1996 was aimed to strike a balance, and still the aforementioned countries argued being damaged, which resulted in adopting of the Doha Declaration on the TRIPS Agreement and Public Health in 2001 at the WTO Ministerial Conference. The main goal of the Doha Declaration was to clarify and amend the TRIPS provisions regarding health care, so that to facilitate the situation with developing and least developed WTO members. Indeed, it was a great achievement for this group of countries to make the rest of the WTO members recognize ‘the gravity of the public health problems afflicting many developing and least developed countries, especially those resulting from HIV/AIDS, tuberculosis, malaria and other epidemics’. What is more important, the WTO members affirmed that ‘the 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’. This research deals with the instruments to enhance public health care, which are stipulated in the TRIPS Agreement and reaffirmed/amended in the Doha Declaration. Noteworthy, that the WTO ministerial declarations are no formally binding on the member countries and in case a collision occurs the treaty will prevail. Nevertheless, the Doha Declaration was adopter to clarify the TRIPS Agreement and in the light thereof, and doesn’t seem to have any contradictory provisions thereto. Thus, the Doha Declaration could serve as a reliable source for TRIPS’ interpretation in case of a dispute.

Monopoly rights of a patent holder to produce, utilize and sell pharmaceutical products can be restricted by applying such mechanism as compulsory licensing. As a result, the government issues licenses to utilize generic drugs without consent from the patent holder. That’s why such licenses are also called ‘involuntary contracts between a willing buyer and an unwilling seller imposed or enforced by the state’. Provisions on compulsory licensing are provided by both the TRIPS Agreement and the Doha Declaration, though the first source doesn’t use the definition “compulsory license”.
In fact, the Doha Declaration provides such the flexibility of compulsory licensing as follows, ‘Each Member has the right to grant compulsory licenses and the freedom to determine the grounds upon which such licenses are granted.’ Notably, the TRIPS Agreement gives us the list of the grounds for the use of patent ‘without authorization of the right holder’. To the listed grounds for issuance a compulsory license belong ‘national emergencies; anticompetitive practices by pharmaceutical companies; the need to establish a pharmaceutical base; and high prices’. However, the member states are free to establish their own grounds within a reasonable scope. Furthermore, the respective provisions of the Paris Convention also can be mentioned in this regard, as they have become the part of the TRIPS Agreement. Thus, the Paris Convention provides the WTO countries with ‘a wide discretion to issue compulsory licenses “to prevent the abuse, which might result from the exercise of exclusive rights, conferred by the patent’.
Very often developing countries and LDCs have insufficient industrial capacities and limited internal market to produce drugs locally in order to promote access to essential medicines. It should be taken into consideration in this respect that the WTO member can freely grant compulsory licenses for foreign manufactures to get generic drugs in the domestic market.

Parallel importation

Parallel importing (also known as ‘grey market import’) is the second most important tool for the developing and least developed countries to boost public health care sector. Parallel importation takes place when one country exercises importing of a certain pharmaceutical product which was lawfully produced, marked and protected in a foreign jurisdiction without the patent holder’s consent. To be more exact, the TRIPS Agreement allows authorizes parallel imports if the patent holder has been already remunerated on the medicines’ first sale and so ‘further compensation on subsequent sale would exhaust their rights’. It is actually called the principle of the exhaustion of intellectual property rights and is foreseen in the Doha Declaration:
The effect of the provisions in the TRIPS Agreement that are relevant to the exhaustion of intellectual property rights is to leave each Member free to establish its own regime for such exhaustion without challenge, subject to the MFN and national treatment provisions of Articles 3 and 4.
Parallel imports can play crucial role in promoting public health interests in developing countries and in the LDCs, as the pharmaceutical industry tends to sets different prices for the same drugs throughout the world. Parallel importing could cope with such market segmentation and discriminatory pricing both internationally and regionally. Undoubtedly, parallel importation of a patented drug from a country where this particular drug is available at a lower price will result in greater access to the medicine and will definitely meet public health needs. At the same time, such actions would in no way prevent the patent holder from being orderly remunerated for the protected pharmaceutical products in the country of the first sale. In short, parallel importation should be considered a legitimate way for the WTO members to protect their public health interests and concerns.

Extension of transition period for the Least-Developed Countries

Pursuant to the Doha Declaration the transition period for the LDCs to implement of the TRIPS provisions was extended from 2006 to 2016:
We also agree that the least-developed country Members will not be obliged, with respect to pharmaceutical products, to implement or apply Sections 5 and 7 of Part II of the TRIPS Agreement or to enforce rights provided for under these Sections until 1 January 22016, without prejudice to the right of least-developed country Members to seek other extensions of the transition periods as provided for in Article 66.1 of the TRIPS Agreement.
As it is evident from the provision, the extension is granted in regard of the pharmaceutical patents only. And notably, that only the least developed countries are engaged (those thirty-four WTO members on the list), whereas the developing ones cannot make use of this rule. Besides, in accordance with the TRIPS Agreement the extension can be accorded by the Council for TRIPS only ‘upon duly motivated request by a least-developed country Member’. From a public health perspective, such extension is seen as a significant achievement of the least developed countries. As stated within the WTO, ‘it is a recognition of the implications of patent protection on public health, and thus, it is recommended that all LDCs adopt the necessary measures to use the 2016 transition period in relation to pharmaceutical patents and test data protection’.

Implementation matters

It should be pointed out, that in order to utilize any of the options mentioned above and provided by the TRIPS Agreement and reaffirmed by the Doha Declaration national jurisdictions must incorporate the respective provisions of international acts into their inner legislation in any convenient form, be it law, ruling, resolution or administrative act. In fact the TRIPS Agreement stipulates that ‘members shall be free to determine the appropriate method of implementing the provisions of this Agreement within their own legal system and practice’. So, as stated, ‘such flexibilities do not automatically translate themselves into national regimes, and do not protect governments (or private parties) from legal actions based on national laws and regulations that fail to make use of the TRIPS Agreement's flexibilities.’

Other tools

Additionally, to promote their health care interests and needs the developing and least developed countries can refer to the following provision of the Doha Declaration, ‘In applying the customary rules of interpretation of public international law, each provision of the TRIPS Agreement shall be read in the light of the object and purpose of the Agreement as expressed, in particular, in its objectives and principles.’ And the primary purpose, as was mention in the very beginning, is to find a balance between IP rights protection and public health care needs.
One more instrument is the provision on technology transfer reaffirmed in the Doha Declaration, though is deemed as ‘soft international law’, ‘We reaffirm the commitment of developed-country Members to provide incentives to their enterprises and institutions to promote and encourage technology transfer to least-developed country Members pursuant to Article 66.2.’

Conclusions

I strongly believe an efficient planning and proper governmental decision-making by the developing and least developed countries will certainly lead to suitable balancing of the IP rights protection and the access to essential drugs at affordable prices to people. In addition, the proper implementation of these respective measures on the national level must be executed.

Bibliography

Legal Sources
'Agreement on Trade-Related Aspects of Intellectual Property Rights' (World Trade Organization ) <https://www.wto.org/english/tratop_e/trips_e/t_agm0_e.htm> accessed 24 February 15
'Declaration on the TRIPS agreement and public health' (World Trade Organization 2001) <https://www.wto.org/english/thewto_e/minist_e/min01_e/mindecl_trips_e.htm> accessed 24 February 15
Articles
A O Sykes, 'TRIPs, Pharmaceuticals, Developing Countries, and the Doha “Solution” ' [2002] CWPS, 9
A N Elbeshbishi, 'TRIPS and Public Health What Should African Countries Do?' [2007] ATPC , 16 < http://www.uneca.org/sites/default/files/publications/49.pdf >
C M Correa, 'IMPLICATIONS OF THE DOHA DECLARATION ON THE TRIPS AGREEMENT AND PUBLIC HEALTH' [2002], 18 < http://www.who.int/medicines/areas/policy/WHO_EDM_PAR_2002.3.pdf >
R Gupta, 'Compulsory Licensing under TRIPS: How far it Addresses Public Health Concerns in Developing Nations' [2010] JIPR 357, 358 < http://nopr.niscair.res.in/bitstream/123456789/10211/1/JIPR%2015(5)%20357-363.pdf >
N S Gopalakrishan, 'TRIPS Agreement and Public Health: An Overview of International Issues' [2008] JIPR 395, 397 http://nopr.niscair.res.in/bitstream/123456789/2025/1/JIPR%2013%285%29%20395-400.pdf
V E Hopkings, 'ANALYSIS OFINTERNATIONAL PATENTPROTECTION ANDGLOBALPUBLICHEALTH' [2005] JPIA 83, 91 < https://www.princeton.edu/jpia/past-issues-1/2006/5.pdf >
Websites
Essential medicines and health products, 'THE DOHA DECLARATION ON THE TRIPS AGREEMENT AND PUBLIC HEALTH' (World Helth Organization e.g. 2005) <http://www.who.int/medicines/areas/policy/doha_declaration/en/> accessed 19 February 2015
'Least-developed countries' (The World Trade Organization ) <http://www.wto.org/english/thewto_e/whatis_e/tif_e/org7_e.htm> accessed 19 February 2015