Law Opinion
Exemption on pharmaceutical patent should continue
Mohammad Yusuf Ali
At present, pharmaceutical industry is a fast-flourishing sector in Bangladesh resulting in exporting products to more than 70 countries. The exemption that Bangladesh and other Least Developed Countries (LDCs) is enjoying from granting pharmaceutical patent up to 2016 has topped among the catalysts behind such boom. Withdrawal of such waiver shall require patent to be granted in pharmaceuticals to witness higher price, narrow market demand and poor public health. But, there are rays of hope! The wording of Para 7 of Doha Declaration 2001 and article 66(1) of Trade-Related aspects of Intellectual Property Rights (TRIPS) agreement offers us bases for hope. They speak of 'Duly Motivated Request' to get such further extensions after 2016. Finding grounds which may really motivate an international forum to offer such extensions for LDCs requires specific research. This is an attempt to find out the grounds which will really matter in such negotiation.
Doha Declaration and public health: Special treatment to public health was implicit in the Doha Declaration 2001. Paragraph-7 of the Declaration runs as follows: “….we also agree that LDCs will not be obliged, with respect to pharmaceutical products, to implement or to apply sections 5 and 7 of TRIPS agreement or to enforce rights provided for under these sections until January, 1, 2016, without prejudice to the rights of LDCs to seek other extensions of the transition periods as provided in art.66 (1) of TRIPS .” Hence, by dint of para-7 of Doha Declaration LDCs are free from granting patent on product and undisclosed information (sec 5 & 7 of TRIPS) in pharmaceutical sector.
Besides granting exemption from pharmaceutical patent up to 2016, para-7 leaves room for further extension in the clause “….without prejudice to the right of the LDCs to seek other extensions of the transition periods as provided in article 66(1) of the TRIPS agreement.” According to article 66(1) of the TRIPS agreement LDCs are entitled to get exemption for 10 years from the date of application from complying with articles 3,4,5(dealing with patent) considering their economic, financial, and administrative constraints and for creating a viable technological base. In such case the council for TRIPS shall accord such extension upon 'Duly Motivated Request'. So, in pursuance of article 66(1) of TRIPS agreement it is possible to extend the exemption period for pharmaceutical patent after 2016 if the request is one which is persuasive supported by facts.
Finding convincing grounds: Finding the grounds which can really motivate the council for TRIPS for granting such extension needs specific research as to status of Bangladesh in pharmaceuticals, manufacturing ability of drugs without reverse-engineering, percentage of persons pursuing self-medication due to poverty etc. However, following grounds may hold good in this regard:
1. Bangladesh can argue that its pharmaceutical industry is passing infancy period compared with that of USA, Switzerland, France, Japan, and Germany. In the list of 10 top pharmaceutical companies of the world by revenue as of March 2010, Switzerland had two companies (Roche, Novartis), France one (Sanofi), Germany one (Bayer Healthcare). In 2008 among the largest 48 companies of the world in terms of revenue Japan had 10 companies. These countries provided pharmaceutical patent when their pharmaceutical industries attained maturity. Switzerland introduced pharmaceutical patent in 1977, France in 1960, Germany in 1968, Japan 1976. In terms of volume India's pharmaceutical industry ranks 3rd in the world. Still India provides only product patent from 2005. Carlos M. Correa (2002), a Professor of University of Buenos Aires writes that, “it is the relaxation Indian patent law after 1970, which enabled India witness such a boom in pharmaceutical industry”. On the other hand, according to Bangladesh healthcare and pharmaceutical report Q1-2011 Bangladesh ranks 67th globally. To be at par with those countries Bangladesh needs more time after 2016.
2. The number of people accustomed to self-medication due to inability to visit doctor can play a decisive role in this regard. According to a survey in 2005 titled “Exploring Health Seeking Behavior of Disadvantaged Population in Rural Bangladesh” it has been found that about 30%-40% people rely on self-medication. People, here, pursue self- medication or OTC medicine mainly to avoid doctors' fee. If patent is granted in pharmaceuticals the prices of medicine will go higher and exacerbate the present healthcare system. So, it can be validly argued that Bangladesh should have the exemption for another period of 15-20 years after 2016.
3. Bangladesh can propagate that “public health” should not be viewed as a matter of trade yielding high return. It is a problem area which warrants both national and international efforts. Suppose, patent protection on AIDS vaccines raises the price very high making a number of patients unable to afford it and die consequently. Would the world community still remain silent allowing companies receive high return? The world conscience is supposed to respond and ensure supply of vaccines or at least negotiate with the traders to reduce the price. The method of compulsory license in national laws allowing generic producers to produce patented products might be well exercised on priority basis. Doha Declaration, TRIPS agreement, national laws-all speak of special protection to public health. So, restriction in trade, patent and high return is implicit in national and international IP laws. Restriction in this case is deemed to have been incorporated to ensure affordable healthcare system throughout the world. Hence, Bangladesh can claim the exemption on pharmaceutical patent to continue after 2016 until its healthcare becomes affordable to everybody.
4. As Doha Declaration was the creator of privileges for LDCs in pharmaceutical patent, they can very validly call for extension of duration mentioned by convening a review of the declaration.
Equality should be ensured among the equals. Equality among the unequal is itself a great inequality. As Bangladesh and other LDCs are not on a firm basis regarding public health, they need the exemption to be extended for another 15-20 years after 2016. It is going to be a hard earned one if not impossible. So, Bangladesh and other LDCs should be well equipped for such negotiation.
The writer is Assistant Commissioner of DC Office, Habiganj.
