E-drug: Pricing and reimbursement of drugs in Baltic States
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[This provides a good overview of some regulatory issues. Notice
the lack of demand put on manufacturers e.g in providing safety
information. This is not a Baltic states only problem but the problem
of very many countries. Another example of manufacturers doing
nothing of their own free will when it comes to providing informa-
tion which might restrict use. Where is the human face? Copied as
fair use. KM]
Lancet 2001; 358 (9278): 260 (28 July 2001)
Pricing and reimbursement of pharmaceuticals in the Baltic States
In the past decade of political and socioeconomic transition, the
Baltic States Estonia, Latvia, and Lithuania, like all other Eastern
European countries, have been under relentless pressure to square
the circle of demand for pharmaceuticals and limited resources.
Joining the European Union (EU) may ultimately provide an
economic and political framework within which the Baltic States will
thrive. The requirements for harmonisation with EU legislation have
already led to an intensive effort to improve standards for drug
regulation in the accession countries, but affordability of medicines
remains a substantial difficulty. The most organised force in the
region is the pharmaceutical industry, which is assertively
developing this new market.
The Baltic States have a total population of 7�5 million, but limited
resources. They allocate about 2% of gross domestic product (GDP)
to pharmaceuticals, which is about US$50 per head of population.
This contrasts with $260 per head in Greece and Portugal, which
also invest about 2% of GDP in pharmaceuticals.1 Historically the
Baltic States have benefited from the availability of generically
produced pharmaceuticals at low prices. For example, 50 enalapril
(5 mg) tablets are available for about $3 wholesale. Newly
introduced proprietary medicines are marketed at prices similar to
those in EU countries. Thus 28 simvastatin (40 mg) tablets are
available at more than $50 wholesale. Attempts to contain the use
of more costly pharmaceuticals, to maintain a reasonable and
equitable coverage of the population, have to withstand pressure
from doctors and patients.
Simply achieving safety in the provision of pharmaceuticals is
difficult for nations not party to the protection of the common
European licensing process. Pharmaceuticals that have been
voluntarily withdrawn for safety reasons in other markets may not
be withdrawn in the Baltic States, manufacturers do not always
supply information on safety concerns, and small agencies may not
identify concerns from third-party sources. For example, the
antipsychotic drug sertindole was not granted a licensed indication
in USA in 1998 because of concerns about its ability "to cause
serious cardiovascular events, including death".2 It has also been
subject to a compulsory suspension of marketing authorisation in
the EU.3 However, in February, 2001, the drug remained available
on an unrestricted basis in Latvia, and the manufacturers negotiated
a reduction in price in 2000, which made the drug less costly than
alternative atypical antipsychotic drugs, such as risperidone and
olanzapine. Similarly, the antihistamine astemizole was eventually
voluntarily withdrawn by the manufacturers after a series of
relabellings in the USA in 1999 because of concerns, primarily
about the increased risk of death and arrhythmias when given in
high doses or in conjunction with other drugs.4 However,
astemizole remained available in Estonia without provision of safety
information from the manufacturers until the marketing
authorisation expired in 2000, at which point the manufacturers
simply did not apply for an extension. In Lithuania the manufacturer
did not share with the licensing authority information on safety
concerns, but no application for the renewal of marketing
authorisation was made in 1998.
How should the Baltic States respond to these challenges? They
should clearly continue their present strategy for developing
collaboration within the Baltic region, with the other Central and
Eastern Countries, and with the western European countries to
tackle common issues efficiently and without duplicating effort.
They already have a mix of co-payments, positive and negative
lists, reference pricing schemes, and basic requirements for health
economics within submissions for reimbursement for
pharmaceuticals.5 Pharmaceutical experts from these regions have
been meeting over these approaches under the umbrella of WHO.
For example, early this year, staff of the Ministry of Welfare of
Latvia and their colleagues from Estonia and Lithuania met with
representatives from various stakeholders (including industry) to
provide an update on the current pharmaceutical situation and to
consider common problems. On the following day the pricing and
reimbursement agencies of the three countries met to discuss
further scope for more intense collaboration. In May representatives
of the Baltic nations participated in a 10-day training workshop in
Budapest, organised by WHO to provide technical skills on the
appraisal of effectiveness and cost-effectiveness of
pharmaceuticals.
Other issues are outside the control of the Baltic States. Exporting
nations should not use their influence to compel the Baltic States to
allow access to costly pharmaceuticals. The accession States might
also reasonably expect the pharmaceutical industry to work in
harmony with EU directives, and more generally to accord due
regard to the importance of safety information on their products.
*Nick Freemantle, Daiga Behmane, Kees de Joncheere
*Department of Primary Care and General Practice, University of
Birmingham, Birmingham B15 2TT, UK; Medicines Pricing and
Reimbursement Agency, Riga, Latvia; WHO Regional Office for
Europe, Copenhagen, Denmark (e-mail:N.Freemantle@bham.ac.uk)
1. Jacobzone S. Pharmaceutical policies in OECD countries. Paris:
OECD, 2000.
2. http://www.fda.gov/oc/oms/ofm/budget/2000/fooddrugstat.htm
(accessed on July 24, 2001).
3. http://www.open.gov.uk/mca/aboutagency/regframework/csm/
csmhome.htm (accessed on July 24, 2001).
4. http://www.fda.gov (accessed on July 24, 2001).
5. Bloor K, Maynard A, Freemantle N. Can expenditure on drugs
be contained effectively? In: Harrison A, ed. Health Care UK
1995/96. London: Kings Fund, 1996: 173-88.
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