Pharma companies brace for new phase
Analysts suggest innovations as patent looms on generic drugs
Sayeda Akter
Bangladeshi pharmaceutical companies should prepare to maintain growth in local sales and exports and remain competitive in the post-2016 period, when patents will be imposed on all generic drugs, analysts suggest.
Upgrading product quality is one area the companies should focus on, they said. Other suggestions include capacity building in research and engineering and the setting-up of an active pharmaceutical ingredients (API) park to help local companies face the challenge.
Capacity building means innovations, strengthening reverse engineering, training local people and upgrading technology. An API park will help produce raw materials locally and innovate ingredients as well.
The word ‘generic’ is used to describe a product, particularly a drug, which does not have a trademark. For example, ‘paracetamol’ is a chemical ingredient that is found in many branded painkillers and is often sold as a generic medicine in its own right.
In 2001, under the trade-related aspects of intellectual property rights (TRIPS), the World Trade Organisation allowed developing and poor nations to produce generic drugs until 2016 without compulsory licences or paying the patent holders.
According to TRIPS, the least-developed country members of WTO will not have to apply for copyrights for a period of 10 years from the date of application, so they will be able to create a viable technological base for public health.
With that, the WTO trade rules have allowed developing and poor countries — mostly without own drugs industry — to issue a compulsory licence to a third country, such as India or Brazil, to produce cheap generic drugs and to import these to address a public health crisis.
Mustafizur Rahman, executive director of Center for Policy Dialogue (CPD), thinks Bangladesh is yet to enjoy the full benefits of the deal.
“As a least developed country (LDC), we must make use of the opportunity to make lifesaving drugs without paying for patents or licensing. Our local pharmaceutical plants are of international standards and we have better infrastructure, which made it easy for us to benefit from the WTO deal.
“The government needs to take policy measures to safeguard the increasing pharmaceutical industry,” Rahman said. “Initially, the government should set up an API park to enhance capacity with advanced research facility.”
“Least developed countries have sought an extension of the deadline from 2016 to 2021. We have to aggressively negotiate on this point to extend the deadline by five more years,” Rahman said.
Dr Zafrullah Chowdhury, a trustee of Gonoshasthaya Kendra, echoed Rahman. He said the government should encourage investment in raw materials production to face intense price competition in the coming days on locally-manufactured products.
“The first effect of the post-2016 era will be the cost of patents, which will increase raw material prices, and eventually the prices of locally manufactured products,” Chowdhury said.
“At present, most large local pharmaceuticals have to depend on imported raw materials. So it is high time the government encouraged investment in raw material production,” he said. “Otherwise, the present growth in local sales and exports may not sustain.”
There are 250 small, medium and large local and multinational pharmaceuticals operating in Bangladesh, while only seven are producing raw materials.
Currently, the local pharmaceutical market is worth around Tk 7,000 crore. Around 80 percent of total raw materials are imported mainly from China, said industry insiders.
However, local manufacturers are optimistic about maintaining present growth in the post-2016 period.
Mizanur Rahman Sinha, managing director of Acme Laboratories, said the rising prices of medicines will not have a harsh impact on the local consumption of lifesaving products.
“We are ready to embrace the challenge that is likely to hit many Third World pharmaceutical manufacturers. As a method of caution, we are constantly upgrading the quality of our manufacturing plants and products.”
“The quality of our products is far better than any other LDC and most major companies have obtained MHRA (UK) and FDA (US) certification for their products. So I do not think medicine consumption will drop overnight,” added the Acme boss.
Mohammad Mostafa Hassan, general manager of Eskayef Bangladesh Ltd, said huge investment is required to produce raw materials.
“We are optimistic that advanced technological bases to produce new molecules are likely to be developed locally by 2013-14, when investment in the sector will increase manifold,” he said. “We plan to invest in raw material production by that time.”
However, Nazmul Hasan, member of the parliamentary standing committee on health ministry, thinks the time limit should extended, as developing and poor countries are yet to optimally benefit from the deal.
“Most developing and poor countries are yet not enjoying the benefits of the WTO deal. At the same time, WTO still could not finalise the list of patented products,” he said. “We need more time to safeguard the sector, and the timeline should be extended up to 2021.”
Acknowledging poor government preparations in this regard, he said the government is set to handover the API to local pharmaceuticals by the end of this year, which will accelerate capacity building.
sayeda@thedailystar.net
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