Production of patented drugs not well-protected under patent law
Sunday, 4 November 2007
Naim-Ul-Karim
The country's booming pharmaceutical industry that aims to fetch Tk 50 billion through exports by 2015 might face a setback unless the sector's interest in production of patented drugs is protected in line with the WTO declaration, sources said.
The World Trade Organisation (WTO) in 2001 at the Doha round negotiation allowed 50 least-developed countries (LDCs), including Bangladesh, to produce patented drugs until 2016.
But, sources further said, the WTO agreement on Trade-Related aspects of Intellectual Property Rights (TRIPs) obliged the member states to protect production of patented drugs through legal cover of their own for enjoying the waiver benefit.
"But Bangladesh is yet to adopt required legal measures on TRIP regulations that have allowed us to copy world renowned pharmaceutical products in line with the WTO declaration," Nazmul Hassan, secretary general of Bangladesh Association of Pharmaceutical Industries (BAPIs) and also CEO of Beximco Pharma, told the FE Friday.
He expressed his fear that the original patent holders could claim their right and even lodge cases any time as the right for production of patented drugs in the country is not protected by legal means.
Hassan said pharmaceutical industry will be bound to stop production of any particular world-renowned pharmaceutical product in case of claim by its original patent holder.
To safeguard the pharmaceutical sector from such situation, Hassan said, the government needs to introduce addendum to the patent law-1911 that "Bangladesh as an LDC chooses its option not to give product patent until 2016" because the process of amending existing patent law is being delayed.
Besides, he said, as per WTO agreement there should also be provision in the patent law that 'compulsory licensing will be allowed both for local consumption as well as export and parallel import'.
When asked, Hassan said, parallel importing, which means a product being sold by the patent owner more cheaply in one country is imported into another without the patent holder's permission, is also possible.
"We have been requesting the authorities concerned for incorporation of such regulations over the last five years," he said.
The BAPI secretary general, however, urged the government to complete the process of amending the patent law by 2015 before the expiry of the WTO exemption deadline.
The country has more than 200 pharmaceutical companies that meet 97 per cent of the total medicine requirement of the local market.
The earnings from export of drugs were recorded at US$ 29 million in fiscal 2006-07.
The industry expects to attract investment worth Taka 20 billion when the proposed API (active pharmaceutical ingredient) Park in Chittagong is established.
Currently, the country's pharmaceutical industry, employing over 0.1 million skilled and unskilled manpower, manufactures about 6000 brands of medicine.
The country's booming pharmaceutical industry that aims to fetch Tk 50 billion through exports by 2015 might face a setback unless the sector's interest in production of patented drugs is protected in line with the WTO declaration, sources said.
The World Trade Organisation (WTO) in 2001 at the Doha round negotiation allowed 50 least-developed countries (LDCs), including Bangladesh, to produce patented drugs until 2016.
But, sources further said, the WTO agreement on Trade-Related aspects of Intellectual Property Rights (TRIPs) obliged the member states to protect production of patented drugs through legal cover of their own for enjoying the waiver benefit.
"But Bangladesh is yet to adopt required legal measures on TRIP regulations that have allowed us to copy world renowned pharmaceutical products in line with the WTO declaration," Nazmul Hassan, secretary general of Bangladesh Association of Pharmaceutical Industries (BAPIs) and also CEO of Beximco Pharma, told the FE Friday.
He expressed his fear that the original patent holders could claim their right and even lodge cases any time as the right for production of patented drugs in the country is not protected by legal means.
Hassan said pharmaceutical industry will be bound to stop production of any particular world-renowned pharmaceutical product in case of claim by its original patent holder.
To safeguard the pharmaceutical sector from such situation, Hassan said, the government needs to introduce addendum to the patent law-1911 that "Bangladesh as an LDC chooses its option not to give product patent until 2016" because the process of amending existing patent law is being delayed.
Besides, he said, as per WTO agreement there should also be provision in the patent law that 'compulsory licensing will be allowed both for local consumption as well as export and parallel import'.
When asked, Hassan said, parallel importing, which means a product being sold by the patent owner more cheaply in one country is imported into another without the patent holder's permission, is also possible.
"We have been requesting the authorities concerned for incorporation of such regulations over the last five years," he said.
The BAPI secretary general, however, urged the government to complete the process of amending the patent law by 2015 before the expiry of the WTO exemption deadline.
The country has more than 200 pharmaceutical companies that meet 97 per cent of the total medicine requirement of the local market.
The earnings from export of drugs were recorded at US$ 29 million in fiscal 2006-07.
The industry expects to attract investment worth Taka 20 billion when the proposed API (active pharmaceutical ingredient) Park in Chittagong is established.
Currently, the country's pharmaceutical industry, employing over 0.1 million skilled and unskilled manpower, manufactures about 6000 brands of medicine.