Abstract
the third-largest market in Central and Eastern Europe (CEE), on face value
Poland remains one of the
biggest opportunities for multinational
pharmaceutical companies. Per capita spending reached
US$272.80 in 2008,
highlighting a growing use of pharmaceuticals, although access to innovative
drugs
remains limited. In this Q409 report, BMI has introduced a new
proprietary 10-year drug expenditure
forecast model. Implementing this
model with macroeconomic and disease burden projections, BMI
forecasts a
compound annual growth rate (CAGR) of 4.41% through to 2018.
In
BMI’s Pharmaceutical Business Environment Ratings for Q409, Poland ranks
third in CEE, behind
Greece and Czech Republic. While headline market
performance remains strong, a number of factors
have constrained a higher
score. The most prominent of these are market risks, including long delays
for
drug approvals, a generic-oriented reimbursement list and weak
intellectual property (IP) regime. While
these factors are improving,
regulatory conditions remain inferior to other countries.
The
Pharmaceutical Research and Manufacturers of America (PhRMA)’s 2009
submission to the United
States Trade Representative (USTR) refers to
considerable procedural barriers in obtaining preliminary
injunctions
against patent infringements, and further that damages awarded for IP
violations were
inadequate – a contravention of the Agreement on
Trade-Related Aspects of Intellectual Property Rights
(TRIPS). Other key
concerns include the presence of ‘ghost’ drugs, whereby generic
copies of patented
pharmaceuticals were approved prior to EU accession in
2004. The potential for re-registering these
medicines in 2008 were
highlighted by the report, although BMI notes that Poland made progress in
filtering out these drugs at the beginning of 2009.
As the backlog of
approval requests are added to the list, BMI expects the patented market share
to rise.
While in the short term this depends on improved efficiencies in
the Office for Registration of Medicinal
Products, Medical Devices and
Biocidal Products (URPL) and fiscal backing, over the next ten years
patients should gain access to a much greater proportion of innovative
medicines.
Supply chain margins for prescription pharmaceuticals in Poland
could become fixed, under new
legislation drafted by the Ministry of
Health. The creation of rigid mark-ups is supported by the generic
drugs
body, the Polish Pharmaceutical Industry Employers’ Association, which
believes variability in
prices can lead to unequal access to medicines and
higher prices for consumers.
In the wholesale sector, leading firm Torfarm
looks set to further improve its market share after the
Office of
Competition and Consumer Protection (UOKiK) approved its takeover of fellow
distributor
Prosper. If completed, the deal would leave the enlarged
company with a market share of close to 30%.
The UOKiK found that the
merger would not lead to a substantial reduction in competition.
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