[e-drug] US-Malaysia FTA and access to medicines

E.DRUG: US-Malaysia FTA and access to medicines
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Dear E-druggers

Few months ago Malaysian MoH, WHO & TWN organized a
workshop in Kuala Lumpur to measure the effect of
proposed US-Malaysia FTA on access to medicines. A new
economic model (developed by Prof Joan Rovira, Spain)
was used to measure the likely impact of stronger IPR
on medicine prices and we estimated that if all
standard USFTA provisions were accepted,
pharmaceutical expenditures would increase to 46%. We
also estimated if the proportion of patented drug
increases (which is most likely to happen), the
expenditure would increase to 28% while medicine
consumption may reduce to 36% (The simulation period
was 2007-2047)

However, few days ago a report was published in a
Malaysian newspaper (below pls find the complete text
http://www.thesundaily.com/article.cfm?id=15437) in
which pharmaceutical industry states that the drugs
will remain affordable after signing of a FTA. It also
states that the positive growth of the generics
industry has been observed in the countries such as
Australia and Singapore after an FTA with the US.

I am still wondering about these claims and will be
thankful if the e-druggers from Australia or Singapore
can shed light on the issue.

Best Regards

Zaheer

Zaheer-Ud-din Babar, MScPharm
Senior Lecturer
School of Pharmacy
University College Sedaya International
Lot 18113, Off Jalan Cerdas
Taman Connaught, Cheras
56000 Kuala Lumpur
MALAYSIA
Tel: +60-3-91018880 Ext: 383
Fax: +60-3-91023606
horizon_pharm@yahoo.com

Medicine will remain affordable, pharmaceutical
industry assures ( copied as fair use)
http://www.thesundaily.com/article.cfm?id=15437

PETALING JAYA: The pharmaceutical industry has given
some measure of assurance to parties concerned with
the impact of a Free Trade Agreement(FTA) with the US
on access to affordable medicines.

Among the main concerns over the current (FTA)
negotiations between Malaysia and the United States
were on data exclusivity and its effect on access to
affordable medicines, especially anti-retroviral drugs
for people living with HIV/AIDS.

Speaking from the perspective of pharmaceutical
companies at a forum last Friday (Sept 8, 2006),
Pfizer Malaysia managing director John Latham
highlighted the positive growth of the generics
industry in countries such as Australia and Singapore
after an FTA with the US.

The US-Australia FTA was signed in 2004. According to
data from IMS Health, generic medicines accounted for
15% of the Australian government spending on drugs in
2005 when in 1994, it was just 2%. This is expected to
rise to 25% in the long-term and hit a market value of
RM4.5 billion by 2010. (IMS Health is a global source
for pharmaceutical market intelligence.)

Furthermore, the net profit of one of Australia's
newest generic companies, Arrow Pharmaceuticals, grew
at 54% in 2004 compared with 39% in 2003. Another
generics company, Alphapharm, was the market leader by
volume and ranked second in market share by value in
2005 which placed it ahead of overseas-based
companies.

Singapore, which also signed the FTA in 2004, saw an
increase in the number of generics in the market from
784 in 2003 to 847 in 2004 and 941 in 2005,
contributing to a total of 21% increase in generics
from 2003-2005. During the same period, the number of
branded drugs increased by 15%.

According to Latham, among the reasons for the growth
in generics in these countries were preferential
policies towards generics, growth in exports, new
product launches and expiry of patents of innovator
drugs.

On the negative impact of data exclusivity on drug
prices, Latham cited Colombia where there had been
similar concerns over the intellectual property tool.
An IMS study in Columbia found no impact on price nor
a change in pharmaceutical industry trends after
almost three years of data exclusivity.

It was predicted that data exclusivity (a period where
companies generating research data holds exclusive
rights over that data) would cause the generics
industry to lose 71% of their market share or wipe
them out altogether.

On the contrary, three years after, the volumes of the
generics industry increased from 53% to 61% while
volumes of branded drugs decreased from 46% to 38%.

At the same time, the value of generics increased from
34% to 39% while the value of branded drugs declined
from 65% to 60%.

On concerns that data exclusivity will remove a
government's right to negotiate medicine prices,
Latham stressed that no country thus far, where data
exclusivity has been implemented, has given up its
ability to invoke sovereign rights in a healthcare
emergency.

"Prices are determined by market forces, competition
and pricing policies and an enhanced intellectual
property environment does not impact the government's
ability to negotiate medicine prices. Sovereign rights
is not affected by an FTA," he said.

Countries in the Asia Pacific which observe data
exclusivity include Australia, New Zealand, China,
Japan, Singapore, Taiwan and South Korea. The period
of protection ranges from five to 10 years.

Responding to claims that prices of drugs increase
annually by over 20%, Latham said: "Average annual
price increase for Pfizer in Malaysia is around 2%.
Merck, Sharp and Dohme (MSD) has had two rounds of
price cuts on their HIV drugs since 2001."

MSD has reduced price of HIV drugs by 78% in 2001 and
another 10% last year.

Pharmaceutical companies also support the government's
efforts in distributing free anti-retroviral drugs by
selling it at a lower market price to the government.

Updated: 07:37PM Tue, 12 Sep 2006