| As the
European Union gets ready to receive 10 new members in May
2004, the countries of eastern Europe are finalising pharmaceutical
legislation in preparation for entry into the enlarged market.
Among
the first wave of entrants will be Poland, which is the
largest of the candidate states with a population of 39
million. Although there are still a number of obstacles
to overcome before Poland is ready to sign the accession
treaties, considerable progress has been made to incorporate
EU pharmaceutical law into its national legislation.
The
new Pharmaceutical Law, which is harmonised with EU law,
finally came into being on October 1st 2002. The law was
initially approved prior to the autumn 2001 parliamentary
elections, but was delayed due to a change of government
and several amendments. The enabling decrees, however, which
were due to be published and implemented at the same time
to allow the practical implementation of the law, had still
not been published by the end of 2002 and are anticipated
in early 2003. The new law covers the areas of registration
and marketing authorisation, manufacture, advertising, distribution,
and pharmaceutical inspection.
Registration delays
The new Pharmaceutical Law
has changed the procedure and organisation of the registration
process. A new Office of Registration was set up in October
2002 to replace the Bureau of Drug Registration. Unfortunately,
the Office is not independent and the Drug Commission will
have a much-reduced advisory role. Controversially, increased
power has been given to the Minister of Health in granting
marketing authorisations.
Considerable deterioration
and delays in the process of registration can be expected
over the next few years as the new Office of Registration
has to cope with a backlog of registration applications,
updates to registration dossiers, and new methods of processing
and assessing registration applications in line with the
new Pharmaceutical Law.
Advertising concerns
Of great concern to pharmaceutical
manufacturers is the section of the new Pharmaceutical Law
relating to advertising. Until the enabling decrees are
published and implemented, companies are unsure of what
they can and cannot do, and many are acting cautiously and
trying to be more ethical in their marketing practices.
The Polish market has a tradition for illegal bribing of
doctors.
There is some apprehension
that the new law will not make much difference to the promotional
practices of many companies long-term, as although the law
is quite strict, there could be problems with implementation
by the Chief Pharmaceutical Inspectorate (GIF), which may
not be able to increase its resources to cope with the additional
responsibility.
Parallel trade
Parallel
trade is a great unknown at this stage, and of huge
concern to the international pharmaceutical industry. Once
Poland becomes a member of the EU, goods will be able to
move freely from Poland to the EU and from the EU to Poland.
Off-patent drugs and drugs fully protected by patents in
the accession countries will be potential legal candidates
for parallel trade.
Multinationals,
fearing an influx of cheap products into the EU from Poland,
have made representations to the European Commission to
ask for a transition period for Poland, much as was the
case for Spain and Portugal when they acceded. So far, the
EC has not accepted this. It is likely, however, that those
products of foreign companies which do not have full patent
protection in Poland will be subject to special terms.
According
to Janice Haigh, IMS Consulting's
expert in the area of pharmaceutical pricing and parallel
trade, however, the concerns of multinationals have been
driven by the perception that drug prices are low in Poland
and other accession countries. While this is generally true
of local products and branded generics, prices of leading
branded products typically targeted by parallel traders
are actually higher in Poland than in many other EU countries.
Often these products are not reimbursed and hence sales
volumes are low.
 Source:
IMS Consulting
In the
short term at least therefore, Haigh believes, the low price/high
volume markets of Spain, France and Italy will continue
to be more attractive sources of imports than Poland and
other accession countries.
Domestic
industry prepares
Poland's imminent entry into the EU is seen an opportunity
by some domestic companies and as a threat by others. The
leading domestic companies are gearing up to attack the
European market aggressively once Poland becomes a member
of the EU, realising that their future success depends on
their performance in the wider European market.
Further
information on the Polish pharmaceutical market is available
in the IMS
Market Prognosis Central and Eastern Europe
report, which also covers: Bulgaria, Czech Republic, Hungary,
Slovak Republic, Slovenia, and Turkey.
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