The Fourth WTO Ministerial Conference 2001, named as Doha Declaration, announced a declaration on Trade-Related Aspects of Intellectual Property Rights (TRIPS), which arranged the minimum standards for the protection of intellectual property, including patents for pharmaceuticals. TRIPS increases the level of protection of the investment of the patent holders in the pharmaceutical sector but it restricts the access to medicine. The implementation of TRIPS has an upward effect on drug prices due to increased investment on research and development, commercialisation of drugs expenditure etc.

The TRIPS agreement was the inspiration of an industrial coalition of developed nations including the United States of America (USA), the European Union (EU) and Japan. The main stimulus for the agreement came from the multinational pharmaceutical corporations and the Intellectual Property Rights Committee (IPC).

The TRIPS agreement allowed flexibility to LDCs (Least Developed Countries) in implementing laws and regulations. The objective was to enable them to create a feasible and effectual technological base. The transition period for LDCs for implementation of the TRIPS agreement extended from 2006 to 2016. However, this extension is related only to patents and marketing rights, data protection for pharmaceutical products. Thus, LDCs are still required to implement the rest of the agreements under the TRIPS as of the 5th Ministerial Conference 2005, held in Hong Kong. For LDCs, the extension of the transition period has a significant importance. The importance is that all LDCs take on the necessary steps to use the opportunity of 2016 transition period in relation to pharmaceutical patents and data protection.

According to the United Nations, 48 countries are classified as LDCs, of which 31 are members of the WTO. Out of 31 LDCs, only Bangladesh has adequate pharmaceutical manufacturing capability and it is nearly self-sufficient. According to Bangladesh Pharmaceuticals and Healthcare Report Q1 2012, Bangladesh is in the 15th position of the 18 markets in the Asia-Pacific region. Bangladesh's pharmaceutical rating is 41.3 out of 100, which is substantially lower than the average of 53.7 of the region. Bangladesh is now below Pakistan and above Sri Lanka in matrix ratings. According to Bangladesh Pharmaceuticals and Healthcare Report Q1 2011, Bangladesh medicine sales reached Tk 70 billion in 2010, the growth trend would take the sales to Tk 90 billion in 2011 and globally Bangladesh would hold the 67th in Business Monitor International's (BMI) 83 market-strong pharmaceutical world. Bangladesh pharmaceutical industry provided 96 per cent of the local pharmaceutical needs. Bangladesh pharmaceutical industry exported worth of 3813.50 taka pharmaceutical products to 83 countries including Europe and America in 2010.

There are 245 registered pharmaceutical manufacturing companies in Bangladesh. Note that, pharmaceutical market in Bangladesh is dominated by top 10 pharmaceutical companies. Top 10 pharmaceutical companies represent about 65 per cent and top 20 pharmaceutical companies represent about 83 per cent of total pharmaceutical market. Bangladesh pharmaceutical companies export tablets, capsules, syrups, specialised products like inhalers, suppositories, steroids, nasal sprays, injections, anti-cancer drugs, anti-retroviral drugs for HIV/AIDS and anti-bird flu drugs.

Some persons thought Bangladesh's sales of pharmaceutical products would decline from 2005. Because the pharmaceutical industry then met 96 per cent of the local demand but local drug market produced only 5-7 per cent of the total Active Pharmaceutical Ingredients (APIs) and imported rest of the APIs. Bangladesh imports therapeutic ingredients (raw materials) from developing countries like India and China which provided full patent protection after January 2005. As a result APIs exports to Bangladesh were obstructed. But Bangladesh pharmaceutical industry overcame this obstacle by increasing the production of APIs and importing raw materials at a higher price. Although the sale of Bangladesh's pharmaceutical products did not decline, the price of pharmaceutical products increased. The ultimate solution lies in the production of APIs domestically. Note that, a US $30 billion API industrial park is under construction at Gajaria upazila in Munshiganj and it is expected that Bangladesh can save at least 70 per cent of cost of raw materials when the industrial park goes into production.

Bangladesh is a country of 155 million. Although the country has made a good progress in the socio-economic field - increasing the literacy rate, improving life expectation, increasing food production, decreasing infant mortality and total fertility - poverty reduction progress is very slow. Macro-economic growth could not help reducing poverty and income inequality. According to the World Bank, less than $2 per day income is considered as absolute poverty and in Bangladesh, the percentage of the population living on less than $2 is 76.5 per cent (World Bank, 2010). Bangladesh's HDI index is 0.50 which indicates the position of 146 out of 187 countries. According to preliminary report on HIES 2010, poverty estimated at 31.5 per cent (based on upper poverty line), 17.6 per cent (based on lower poverty line), the Gini co-efficient of income is 0.458 and Gini co-efficient of consumption expenditure is 0.321.

The per day income of 76.5 per cent people of the country is below $2 and it is difficult to ensure their access to medicines at higher prices. Moreover, the medicines of diseases such as HIV/AIDS, avian flu, Hepatitis C, Aplastic anemia, cancer, heart diseases are very expensive.

TRIPS can affect the access to medicine in multiple ways. The most expected affect is direct because implementing patent rights increases the price of all types of medicines. There are basically two types of patent rights: 1) those that protect methods of manufacture (process patent) and 2) those that protect pharmaceutical products (product patent). In both cases, pharmaceutical farms are bound to pay a heavy portion to the patent holder when TRIPS is fully implemented. As a result, their production cost rise and they will recover their increased production cost by increasing the medicine price.

It is apparent that present research and development infrastructure and the technology of Bangladesh pharmaceutical industry are not as developed as in developed country. Moreover, the opportunity and fund for research is inadequate. There is hardly any possibility that the country's pharmaceutical sector would be able to increase fund, develop R&D facilities and research opportunities to the world standard by January 2016 in compliance with the TRIPS agreement. The present situation is not suitable for Bangladesh to implement the TRIPS agreement as scheduled.

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