[Ip-health] Thai Nation: Red Tape Is Blocking Access to Badly Needed Generic Drugs

[Mike Palmedo]

http://www.nationmultimedia.com/page.news.php3?clid=11&theme=A&usrsess=1&id=116157

BETWEEN THE LINES: Red tape is blocking access to badly needed generic
drugs

Published on Jun 26, 2004

Indian generic drug producer Cipla stunned the world, or to be more
accurate international producers of branded pharmaceuticals, in
February 2001. The Bombay-based company announced it would sell its
triple combination of anti-retroviral drugs at US$350 (Bt14,200) per
patient per year to Medecins Sans Frontieres, or $600 per patient
annually to any country.

Cipla's announcement is significant in that it came at a time when most
anti-retroviral therapies from major drug firms were and are priced
prohibitively high. Even those drugs for which the price has been
drastically cut under special programmes for African countries still
cost over $1,000 per patient per year. The same combination of drugs in
the US costs about $10,400.

Given Cipla's contribution to global efforts to improve access to
essential medicines, the recent announcement by the World Health
Organisation to remove two anti-retroviral medicines from the WHO's
list of pre-qualified products is a cause for concern. The two drugs
are Lamivudine 150mg tablets, and Lamivudine 150mg plus Zidovudine
300mg tablets.

There are two issues of concern here - the quality of the drugs and the
impact the announcement might have on the promotion of generic drugs.
Local health officials, who say they will keep a close eye on Cipla
products, have already voiced the first concern.

Producers of original anti-retroviral drugs often questioned the
quality of the drugs made by generic producers, so too do many doctors.
Vigorous marketing of pharmaceuticals often means that these doctors
are loyal to and trust original drugs over generic alternatives.

Health experts also agree that WHO standards are necessary for the
benefit of patients everywhere. The pre-qualification process involves
checking product files, and inspecting manufacture sites. The
information submitted in the product files is also verified against raw
data from the laboratory contracted by the manufacturers to carry out
bio-equivalence studies (testing whether the blood concentration of the
generic drug is similar to that of the original).

The WHO requires bio-equivalence testing for products prescribed for
serious conditions requiring assured therapeutic response. Not all
countries require bio-equivalence standards for generic products.

The WHO said the data and information Cipla originally submitted for
pre-qualification in the product files met international standards for
quality as well as bio-equivalence, hence the medicines were considered
eligible and were placed on the approved list.

However, a WHO inspection of the laboratory used by Cipla to carry out
the bio-equivalence studies found the lab was not compliant with WHO
standards of good clinical and laboratory practices. The raw data from
the lab also failed to prove bio-equivalence. The WHO therefore,
removed the two products from its list.

However, the WHO maintained that Cipla's products were still compliant
with quality standards with regard to active pharmaceutical
ingredients, impurity profile, formulation and manufacture. What's
missing is proof of bio-equivalence. For Cipla to return their products
to the WHO's list of pre-qualification products - which the company has
said it will do soon - it has to submit fresh bio-equivalence data.

Once the data is evaluated by the WHO and found to be reliable, the WHO
will consider putting the drugs back on the list.

Paul Cawthorne, country coordinator of MSF (Belgium) in Thailand, said
the WHO's pre-qualification process often involved huge volumes of
documentation, sometimes weighing up to 3kg. He agreed that the
pre-qualification measures are important to protect the health of the
patients and to create confidence among buyers of the products.
However, he also contended that sometimes this time-consuming process
has delayed attempts by smaller manufacturers to have their products
WHO-approved. In practice, the introduction of generic drugs has
frequently been delayed.

Not everyone is happy with WHO standards, however. Generic producers in
developing countries said the pre-qualification process had obstructed
rather than promoted the use of generic drugs.

Producers of original drugs, meanwhile, fear WHO standards might be too
lenient towards generic producers in developing countries, enabling
more pharmaceutical producers to compete with them in the global arena.

For others, how the drugs work in the field is the most important issue.

"Patients are dying in the developing world and we are still searching
for standards that we cannot afford or manage," said Krisana Kraisintu,
former head of the Government Pharmaceutical Organisation's research
and development unit. She is now helping with the production of
anti-retroviral drugs in the Democratic Republic of Congo.

Access to treatment and care for people living with HIV/Aids is
becoming a global issue. The ability to produce generic drugs is vital,
as it allows more people access to such drugs. Generic manufacturers
must not allow themselves to become obstacles to this effort by failing
to conform to standards. Health regulators, meanwhile, can also promote
more affordable drugs by adjusting official procedures to speed up the
approval process without compromising necessary quality standards.

Mukdawan Sakboon