Bangladesh pharma industry in the days ahead

The pharmaceutical industries of Bangladesh manufacture about 8000 generic drugs under 26813 registered brands in different dosages and strengths. The government also controls the price of 209 generic drugs in specified dosage forms along with imported medicines and 41 APIs (active pharmaceutical ingredients) produced in the country.
Besides this, some top edge companies already started producing anti-cancer and antiretroviral drugs previously being imported from abroad. The pharmaceutical market size as per BMI is: Tk.138.81 billion (US$1.78 billion) in 2013 and Tk.154.62 billion (US$1.99 billion) in 2014; +11.4 per cent in local currency and +11.9 per cent in US dollars.
 Among the 258 licensed pharmaceutical companies, almost 80.0 per cent of pharma business is controlled by 30 companies and almost 98.0 per cent of the over US$2.0 billion pharma market of the country is catered by a total of 50 companies. It is indeed appreciable that after meeting 97.0 per cent of the local demand, we are presently exporting to about 87 destinations of the world including stringently regulated markets in Europe along with the mild regulated countries like the Philippines,Vietnam, Singapore, Sri Lanka and 49 LDCs in Asia pacific and Africa.
Our yearly pharmaceutical exports are as follows:
Tk.4.21billion in 2011(+29.0 per cent over 2010)
Tk.5.396 billion in 2012 (+28 per cent over 2011)
 Tk.6.20 billion in 2013 (+15 per cent over 2012)
Tk.7.33 billion in 2014 (+19.0 over 2013)
The number of exporting firms ranged from 35 to 47, according to available sources.
The LDC's have been enjoying a patent-free regime till 2016 as per WTO/TRIPS agreement. As per latest development, WTO member states have to legislate and enforce the minimum standards for the protection of intellectual property such as copyrights, patents, designs, trademarks. As such local pharmaceutical manufacturers will have to cease production, distribution and sale of medicines that come under this intellectual property rights agreement as elsewhere in the world. But WTO could not specify the number of products classified under patent protection rights that may be 25.0 per cent of the total branded generics and this will initiate a major change in the industry scenario. First, price control will be lifted. Producers will have to pay for their patented products, as well as license fees. But stipulated agreement clauses for export of patented products may create problems, as Bangladesh cannot export patented products without patent owners' approval, which will be more costly. In addition, foreign firms will get free access to local market, and multinationals can produce several products in Bangladesh that are not allowed now.
 However, it may be noted that 75 per cent of the drugs in the WHO list are not subject to patent protection. And many of the products in Bangladesh are generics, and thus not subject to WTO patent protection jurisdictions. However, costs of licensing fees, impeded access to export markets, withdrawal of local protection may cause a considerable hike in import costs. This is why, forward-looking local drug manufacturers will have to adapt their product portfolio as required or else suffer a steep drop-off in sales. However, the global 'patent cliff' may mitigate this to some extent if we could develop reverse engineering mechanism like India/China along with internationally accredited bio-equivalence test laboratories in Bangladesh to comply with the original kinetics and dynamics of pharmaceutical products under the drug regulatory acts.
As implementation of the much dreaded TRIPS (Agreement on Trade-Related Aspects of Intellectual Property Rights) has been haunting the global pharmaceutical industries for years, twenty drugs, including cholesterol-lowering Atorvastatin Lipitor of Pfizer, blockbuster blood thinner Plavix of Bristol-Myers and Sanofi, Eli Lilly's atypical antipsychotic Zyprexa and Takeda's diabetes medication Actos will become generic drugs in the years ahead.
By the year 2016, the world's best-selling drugs, with about $255.0 billion in global annual sales, are set to go off-patent, as recent data from London-based research firm Evaluate Pharma has revealed.
Once the blockbusters lose their patent protection, lower-price generics are expected to decimate as much as 90.0 per cent of the sales of innovator companies.
Under the changing circumstances, leading pharma companies will have to look for new ways and strategies to fill the gap instead of relying on traditional patent blockbuster models. All industry players will have to embrace the generic market model as an increasingly important part of the overall pharmaceutical lifecycle in conformity with the economies of LDCs like Bangladesh.

The writer is a former CEO of a pharmaceutical company.
wahidur707@gmail.com