Abstract
Lebanon remains a strong pharmaceutical market in the Middle East and Africa
(MEA) region. In BMI’s
updated Business Environment Ratings for
Q309, Lebanon holds a respectable 13th position. The
country’s
pharmaceutical market was worth US$500mn in 2008, and is expected to grow to
be worth
US$517mn in 2009. BMI forecast that the market will grow by
around 21% over five years to reach
US$603mn by 2013, representing a
compound annual growth rate (CAGR) of 3.82%. Its low ranking is
due to a
poor regulatory and intellectual property (IP) regime, small population size,
political volatility
and limited healthcare finances.
The
country’s IP environment remains lacking in relation to international
standards, and drug patent laws
are a particularly contentious issue. In
October 2008 the Lebanese Council of Ministers approved
implementing
regulations for the 2003 Law 530, which establishes a new process for
registering and
importing pharmaceuticals. However, these regulations are
yet to be implemented.
The Lebanese government introduced a new patent law
in July 2000, granting 20 years of product patent
protection and replacing
1924 legislation. However, standards remain poor and enforcement lax. The
USbased
Pharmaceutical and Research Manufacturers of America (PhRMA)
voiced concerns over a lack of
both data exclusivity and pipeline
protection, as well as the registration of unauthorised products. As a
result of various deficiencies, the Office of the US Trade Representative
(USTR) again listed Lebanon on
its Priority Watch List in its 2007 Report
on intellectual property rights (IPR), despite some progress in
2006 by a
Lebanese IP rights task force. PhRMA’s Special 301 Submission 2009
expressed on ongoing
concern that significant market access and IP
barriers characterise the Lebanese market. Key problems
include lax IPR
enforcement and the unfair use of commercial data aimed at securing marketing
approval.
The Ministry of Health failed to take into account the comments
of PhRMA member companies in
developing the content of the implementing
regulations for Law 530 despite PhRMA member companies
meeting with the
minister of economy and trade in 2008.
Despite the reduction in costs, the
generic market remains underutilised in Lebanon as doctors do not
generally have information on the availability of therapeutically equivalent
generics and are encouraged
to prescribe only branded drugs. Additionally,
the fact that many generic products in the country are of
dubious quality
is a deterrent, while the large number of pharmacists in the country makes for
stiffer
competition. This creates a preference for selling expensive,
patented and branded drugs to obtain to
higher profit margins.
The
Lebanese Consumers Association (LCA) has emphasised that off-patent drugs
should be better
regulated and promoted and that pharmacies should be
encouraged to purchase more generic medicines so
patients can make an
informed choice.
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