By Leong Sze Hian /
I refer to the licensing and registration fees for medicinal products.
Before 1991, there were hardly any fees payable for the registration of medicinal products.
When registration began in 1991, the per product licence fee was $66 a year ($200 for 3 years). Since the regulatory agency, the Health Sciences Authority (HSA) was created on 1 April, 2001, the fees have increased to $80, $100, $120, $360, maximum of up to $32,500, $77,500 and $85,250 per first year fees, in 1992, 1996, 1998, 2003, 2006, 2007 and 2011, respectively.
Using the maximum fee per year as a benchmark, fees have increased at a compound rate of 93 per cent per annum, over the last 10 years, since the creation of the HSA.
Another example is the annual licence fee for each product licence, which increased from $60 in 2005, to $100 and $300 in 2006 and 2007, respectively.
This has resulted in pharmaceutical businesses reducing their product lines and is also a deterrent to expanding their product range in Singapore. The higher costs are also being passed on to consumers. More Singaporeans are buying from Johor Bahru and neighbouring countries.
For example, the price of Norvasc 5mg tablet box of 30 for heart condition and Lipitor 10mg is $26.50 (RM65) and $51 (RM125) in Johor Bahru, compared with $75.20 and $96, respectively, in Singapore.
Pay and pay?
In the context of Singapore’s small population, on a per capita basis, our registration fees for new and generic drugs may be one of the highest in the world. This may also affect Singapore’s plans to become a biomedical hub.
The latest maximum $82,250 registration fee for a new drug may deter the introduction of new drugs. This may deprive patients of much-needed new drug treatments.
According to the HSA’s FY2009/10 Annual Report, it had 131,000 Cosmetic Products Notified Under ACD, 5,349 Registered Medicinal Products, but only 155 New Product Licenses Issued.
For example, had the new $82,250 registration fee been in force when Viagra was introduced in Singapore, it may never have made it to the pharmacies – which may result in an even lower procreation rate. For new drugs that are already approved by the Food and Drug Administration (FDA) of the United States, why do we still need to impose a registration fee as high as $85,250?
To put this in perspective, according to the ChannelNewsAsia programme, War on Cancer, on Feb 11, 2007, the cost of cancer drugs has gone up 500-fold over the last decade.
Singapore may like to rethink its strategy before going down the road of trying to emulate the best in the world for the registration of drugs. The time period required for registration has also risen from three months previously to as long as over two years now.
Studies have indicated that the duration of registration approval in Singapore is one of the longest in Asia. Consequently, while other countries launch new and more advanced products, Singapore may be lagging behind.
In FY2009/10, there were 6,989 Enquiries on Classification, Import and Sales Requirements of Health Supplements.
More agencies and regulations? Enquires on Classification, Import & Sales Requirements
It would appear that every time a new regulating agency is created, businesses and consumers may end up paying much more. In fact, the fees only started to escalate when the new regulating agency (HSA) was created.
The HSA’s Total Operating Income, Expenditure and Assets, increased from 67 to 71, 118 to 136, and 150 to 159 million, respectively, from FY2009/09 to FY2009/10.
In 2007, the Pharmaceuticals Industry Trade Association (PITA) wrote to the Chief Executive Officer of the HSA, and subsequently to the Health Minister to voice its concerns on the above.
At a subsequent dialogue between the Health Ministry, HSA and the PSS, the oral assurance was given that they would be mindful of any registration fee increase in the near future. In this connection, fees have continued to rise, and the maximum fee has gone up by as much as $85,250 now.
Protect Singaporeans by forcing more to buy from less regulated countries?
The HSA was founded with the Vision – “To be the leading innovative authority protecting and advancing national health and safety”. Perhaps in its overzealousness to “wisely regulate health products and to safeguard public health”, it may have contributed to raising costs so much that more and more Singaporeans may be turning to much cheaper and less regulated drugs from other countries. Thus, negating its original primary objective of protecting Singaporeans.
P.S. The latest fees are available at http://www.hsa.gov.sg/publish/hsaportal/en/health_products_regulation/western_medicines/licences/fees.html