| Latin
American pharmaceutical markets have traditionally been typified
by a proliferation of non-bioequivalent, branded generic and
copy products (similares), which are extensively used in the
public sector. In recent years, however, government policy
has been heavily geared towards promoting true, unbranded
generic markets. This has been most noticeable in Mexico,
with the introduction of the 'interchangeable generics' ('genéricos
intercambiables') (GI) class back in 1988, and the more recently
proposed policy of preferential purchasing of bioequivalent
products in the public sector.
In all countries, public sector doctors are increasingly
being forced to prescribe generically. Generic substitution
is already mandatory on patient request in some countries
and pending in others. In Brazil and Venezuela, doctors
must rule out substitution if they require a particular
brand of drug to be dispensed but pharmacists must still
inform patients about cheaper alternatives. Generic substitution
will become more widespread once bioequivalence regulations
are fully in place, primarily because this will increase
physician, pharmacist and consumer confidence in these drugs.
Generic markets in this region have benefited from the
difficult economic climate, which has forced more patients
to select these drugs in preference to original brands for
cost
containment reasons. Consumer marketing programmes have
also played a key role in developing the market. In Venezuela,
leading national players have undertaken extensive advertising
campaigns to help increase awareness and acceptance of generics.
In Peru, promotion of own-brand generics by leading pharmacy
chains has helped to increase the number of generics sold
in the over-the-counter (OTC) sector of the market.
The following chart illustrates the relative share of unbranded
generics in each of the seven countries covered by Market
Prognosis Latin America. Noticeably, in volume
terms, Chile has the most developed generics sector, accounting
for 21.5% of the total pharmaceutical retail market in the
year to September 2004, but due to the fact that generic
prices are so low in that country, generic sales accounted
for only 6.9% of the total market in value terms. In most
countries, the generics segment is taking an increasing
share of the total pharmaceutical market, both in volume
and value terms, though in Venezuela and Peru, volume rather
than price is the key driver of market growth.
Generic audited market shares
(12 months to September 2004, at ex-maunfacturer level)*
*Note:
Includes products marketed under the generic name of their
active ingredient(s) and excludes copy products and branded
generics.
Source: IMS Health
Bioequivalence/bioavailability
requirements remain a highly sensitive issue in Latin America
and a subject that divides multinationals and local companies.
The introduction of bioequivalence regulations has been
hampered by a number of issues, including the high cost
of conducting the tests, the lack of testing facilities,
and, arguably, a desire to protect the local industry.
Brazil
leads the way
Brazil
is probably furthest along the bioequivalence path. Unbranded
generics are already subject to bioequivalence testing,
whilst the many branded copy products on the market will
be tested under a 10-year programme that commenced in 2004.
The early signs are that the regulatory body ANViSA intends
to rigorously enforce bioequivalence standards. The first
phase of its bioequivalence programme, which affected only
21 active ingredients, resulted in the marketing authorisations
for well over 100 products being revoked in December 2004.
The
second phase of the bioequivalence programme will be much
broader, spanning seven ATC categories (antibiotics, antifungals,
antivirals, antibacterials, antiretrovirals, antiparasitics
and antineoplastics) and affecting several hundreds of copy
products. If this programme goes according to plan, by 2014
all products on the market will have proven bioequivalence
and copy products will no longer be on the market.
In Mexico
there are also plans to introduce widespread bioequivalence
standards. Close to 3,000 GI generics have been commercialised
since the category was introduced in 1998. The shape of
the Mexican generics market, which is currently dominated
by branded copy products, will be transformed over the next
five years if the government presses ahead with plans to
introduce five-yearly re-registration for all pharmaceuticals
and implement bioequivalence requirements across the market.
Together, these measures will eventually result in the establishment
of a market populated entirely by original brands and bioequivalent
generics. While the re-registration process is unlikely
to be completed within a five-year period, the number of
bioequivalent generics on the market will increase rapidly
during the forecast period, while copy product numbers will
decline sharply.
The
Argentinean market is saturated with a large number of non-bioequivalent
copy products and although bioequivalence requirements were
introduced in a 1999 decree, only a handful of active ingredients
have so far been affected. Widespread bioequivalence testing
is therefore unlikely in the next five years. In Colombia,
bioequivalence testing is a requirement for a limited number
of products with a narrow therapeutic margin (eg anti-epileptics
and immunosuppressants). As in Argentina, expansion to other
classes of drugs appears to be low on the government's agenda.
The
Chilean authorities are dragging their heels over the whole
issue of bioequivalence. The plan is to phase in bioequivalence
testing for drugs with a narrow therapeutic index between
2005 and 2009 and include other products thereafter. In
Peru, the issue of bioequivalence is still under discussion.
Likewise, in Venezuela, it remains a matter of debate and
of secondary consideration to Good Manufacturing Practice.
Eventually,
all of these pharmaceutical markets will consist solely
of original brands or bioequivalent generics, but given
the current rate of progress, this is more likely to occur
in the next decade. Meanwhile, there remains considerable
uncertainty over how rigorously bioequivalence regulations
will be enforced in some countries and Brazil and Mexico
will continue to lead the path towards a high quality bioequivalent
generics market.
This
article was written by Eleonora Sandullo, Project Manager
for IMS Market Prognosis Latin America. For
more information on the IMS Market Prognosis
series, please contact Rupesh
Chudasama via e-mail or call +44 207 393 5136. |
