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Impact of TRIPS on local pharma sector
Md. Shah Amran | Thursday, January 27, 2005, 08:00 Hrs  [IST]

The impacts of TRIPS Agreement on local pharmaceutical sector in Bangladesh are long lasting. Under TRIPS Agreement, pharmaceuticals are now considered as any other trade commodity like salt and soyabean oil and therefore it is expected to have the greatest impact on the pharmaceutical sector, in other words, on public health. The impacts of TRIPS agreement can be summarized as follows:
1. Government will be compelled to open the domestic market for multinational companies
2. Local companies have to face an unequal competition in selling medicines with the foreign companies. As a result big national companies will face an economic repercussion and many mid-sized and small companies will be locked causing lose of job of thousand of this sector
3. The price of essential drugs will increase, moreover peoples will be bound to buy patented drug at a higher cost
4. No new local plant will be established and due to no technology transfer and as under TRIPS Agreement multinational companies will export finished goods, therefore, there is no chance of establishing new plant in developing countries.
5. Traditional medical care systems such as Unani, Ayurbedi and homeopathy will be at stake due to patent rule.

So, in this scenario, the following options can be considered:
1. Take the advantage of loophole of TRIPS Agreement such as to consider product patent and process patent separately
2. Take the advantage of transition period on delaying pharmaceutical patents for LDCs. The WTO council responsible for intellectual property, on 27 June 2002, approved a decision extending until 2016 the transition period during which least-developed countries (LDCs) do not have to provide patent protection for pharmaceuticals. It also approved a waiver for LDCs on exclusive marketing rights for any new drugs in the period when they do not provide patent protection
3. Take advantage of compulsory licencing and parallel import.
4. Raise our voice in proper body of UNO (WTO, WHO) to the proposal for "exclusion of essential and life-saving medicines from patentability"
5. Raise our voice to establish our right to 'freely exercise' our legal options in an unrestricted manner to exercise our option to take measures (such as compulsory licensing and parallel imports) already available under the TRIPS Agreement to ensure access to essential medicines.
6. Considering the costs and the socio-economic and developmental implications of establishing the strict IPR regimes required, we have to raise our voice for the reform of the TRIPS Agreement.

Proposals for broad-based research

The TRIPS agreement can be used to ensure access to innovation, invention and affordability of pharmaceutical products and processes even by developing nations, if they desire so. Therefore, as a developing country Bangladesh has to consider all options for multidimensional research on new drug development (and also on other fields of science and technology). In the existing infrastructure now available in this country, it is possible to successfully implement such a project for finding new drug molecule. For this purpose, the following steps can be considered:

Set up of a Central Drug Research Laboratory (CDRL) by the government with direct participation, co-operation and active involvement of (of scientists/researchers/experts coming from the) the Pharmaceutical sector: At present, there are two government owned laboratory at Dhaka and Chittagong to officially evaluate and test the pharmaceutical products either manufactured locally or imported. These institutions can be modernized to perform the activities of CDRL. Also some space of BCSIR, better known as science laboratory, can temporarily be used for this purpose. The research activities of ICDDR, B and BIRDEM can be coordinated with proposed CDRL.

Pharmaceutical firms and Academies: The pharmaceutical sector needs patent on new molecules and academicians need good research. Therefore, there can be an excellent collaboration between the academician from pharmacy, pharmacology, physiology, chemistry, biochemistry, microbiology, biotechnology, bioengineering and allied science departments. Academicians from related disciplines are to be taken into full confidence to conduct research in the respective laboratories of the respective institutions with financial and technical support from the pharmaceutical sector.

Intra-firm and inter-firm research: Big national companies can either individually or jointly run research works within their own 'Research Wings'. Currently existing in the pharmaceutical industries "Research and Development (R & D)" sections can be instrumented for this purpose.

Both academic and industrial pharmacists should have to be involved in research into new chemicals and natural substances with potential medicinal value and also research into new dosage forms of medicines

Research on Traditional Medicines: Traditional or alternative medicines system have been approved by the WHO and in the National Institute of Health (NIH), USA, a new department on traditional/alternative medicines has been opened. These traditional medical care systems have withstood the upheavals of time and has emerged as time-tested therapy because there are demand, logic and scientific grounds on which these disciplines are based on. Recently, national professor Dr Nurul Islam started a medical treatment system combining "Allopathic, Unanai & Ayurvedi and Homeopathy" and it is known as Three Systems Together (TST). Hamdard is one of the leading institutions in Unani medical care system and they also do research on traditional medicines. So, scientists/experts/ scholars from all these disciplines can be involved in research to find good alternative treatment system.

In a broad-based research project scientists from all related disciplines have to work together. Therefore, they have to create congenial work environment and work together to attain the goal, i.e., invention of new drug molecule, new technology. It is also urgent to encounter the challenges of 21st century and 3rd millennium to survive as self-reliant and dignified nation.

A suitable world-class journal to publish research findings (only new/novel findings, innovations, new ideas, new designs) timely and regularly will be the demand of time if a broad-based research project is undertaken.

Also, there must have a rapid communication system to internationalize any patent of new drug molecules or any other intellectual property through WTO. To avoid bureaucratic complexity; it is better to give this responsibility to the pharmaceutical sector or any special committee. One important step is the modernization of the office of patent and design to deal with these matters properly.

As a developing country, Bangladesh must exercise the options already provided for in TRIPS and other international agreements, free from pressure. The national legislation needs to be reformed in a manner most conducive for the individual health, economic and development needs of our country putting into effect the compulsory licencing, parallel importing and other options. At the WTO and WHO, as a developing country Bangladesh will have to participate and support the proposals for changes to the agreement, in order to ensure that IPR protection does not undermine its economic and developmental prospects and also to ensure the access to essential and life-saving medicines and their affordability for all. At the same time, the country has to gear up own strategies to help flourish pharmaceutical sector so that it can stand on a firm base before 2016 with emphasis on basic and applied research in this field.

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