A PHARMERGING GIANT
Increasing competition for low-cost operations can be expected as Eastern European markets liberalize and industrial activities
shift into the former Iron Curtain countries. Beyond manufacturing, Novartis's Bellamy alludes to a similar trend affecting
clinical trials. "The standards of clinical research that this country offers, at relatively low cost compared to Western
Europe, are very attractive for a company such as Novartis," he says. "However, that gap is getting a lot smaller, which is
why there is a challenge for the clinical research based in Poland to reinvent itself and find the next differentiating factor."
Anna Gajec, General Manager of Cegedim Poland
One avenue for reinvention and new competitive advantages is in a burgeoning biotech field. Rare disease specialist and a
newcomer to the Sanofi-Aventis family, Genzyme leads the way in Poland with three reimbursed products that drive country growth:
Cerezyme for Gaucher disease; Aldurazyme for Mucopolisacharidosis I (MPS1); and Myozyme for Pompe disease. Moreover, the product
Fabrazyme for Fabry disease is currently under discussion regarding its reimbursement situation. Pawel Miskiewicz, general
manager of Genzyme North and Central Europe, also looks favorably on his company's room for growth in multiple sclerosis (MS)
treatment. While MS "is a very serious disease that affects many patients in Poland," he notes, "only around 5% of patients
are getting reimbursed treatment right now. This creates enormous opportunities for a company bringing therapeutic breakthroughs.
I strongly believe that Alemtuzumab is just what MS patients need, and Genzyme is the company which can deliver this to them."
While rare diseases are a key part of Genzyme's growth strategy, the inherent risks that come with product development make
it necessary for Genzyme to diversify across therapeutic lines and product areas. It has done this by developing its biosurgery
franchise where it delivers hyaluronic acid injections (Synvisc classic, Synvisc One, Jonexa). Targeting the open market and
fully paid for by patients in pharmacies for competitive prices, Miskiewicz notes that the strategy's high segment penetration
attests to the value-for-money ratio of Genzyme's products. Other franchises that the company has built are in oncology, hematology,
nephrology, and biosurgery. "These are very promising markets, with many unmet medical needs," says Miskiewicz. "The business
paradigm fits well into Genzyme's idea of conducting commercial operations."
GlaxoSmithKline manufacturing plant in Poznan
Unsurprisingly, the growth of biotech in Poland is a function of market access determined by favorable reimbursement—an area
in which Miskiewicz believes Poland significantly trails the rest of Western Europe. "In this part of the world reimbursement
is the main challenge faced by companies involved in rare diseases. Therapies in these areas are extremely expensive; therefore
existence of any sort of the reimbursement system is key." Although from a distance, procedures appear rudimentary, the decision-making
process concerning reimbursement applications are discouragingly lengthy. While the understanding of issues exists, "it is
just a lack of funding." Ultimately, however, Miskiewicz maintains a positive future outlook on biotech in Poland, underpinned
by the structural endowments of the market. "I truly believe that Poland will be a very attractive market to work on. Once
the country finally has a healthcare system set in order, then investments will come." The EU declared 2010 a Rare Disease
Year whereby all member state governments participated in collective forums to present their national plans for approaching
treatment in this arena. "If not for anything else," says Miskiewicz, "only by this obligation does Poland have to be open
to innovative therapies."
The eastward expansion of the European Union could perhaps be the best stimulus for developing innovation in the Polish pharmaceutical
industry. Industry leaders see the increasing number of former Soviet bloc countries opening their markets to innovation as
a benchmark for Poland. Volker Zimmerman, managing director of UCB, holds firm on this view and, much like Genzyme's Miskiewicz,
believes future opportunities trump past and present market access challenges. "Poland has a fantastic chance to be an innovative
country, having joined the European Union in 2004," he asserts. "Thus, innovative drugs should also be available in Poland
at a similar time as in other European countries, as is even the case for the Czech Republic or Hungary. Future-oriented countries
like Poland should be encouraging the launch of innovative drugs on the national market." Globally, UCB's research-based pipeline,
covering primarily biotech products, has a clear focus on unmet central nervous system and inflammation needs. However, due
to market access restrictions, blockbuster products such as a Vimpat for epilepsy treatment, Cimzia for rheumatoid arthritis,
and Neupro for Parkinson's disease have not been launched in Poland despite their placement in other European countries. As
Zimmerman notes, "Sll have been submitted and successfully approved with the same studies and the same medical results in
other countries where the products are already available for doctors and patients."
Don Bellamy, CPO head and country president of Novartis
Driven by innovative therapies, unmet medical needs, and sizeable populations, UCB is betting big on Poland's future. Zimmerman
believes that "Poland can be one of the key countries within the UCB group in the medium term. To a certain extent, Poland
is still a slightly unknown country, even underestimated, that could serve as a model for others when using the existing opportunities
faster." As such, the company is taking proactive steps internally to streamline operation by renewing its workforce, promoting
training, and enhancing various software systems. Outwardly, the focus is to become more attune to market needs. "The company
is preparing itself for various scenarios that introduce greater market transparency as well as research potential partners.
UCB Poland is fully engaged to accelerate the submission and approval process. Meanwhile, the company established the position
of a market access manager and reorganized the medical department as well as the commercial department, with experts who are
more familiar with the overall market conditions, whether it is in epilepsy or rheumatoid arthritis. UCB has also evaluated
and updated medical and pharmacoeconomic data, so that the company can submit a competitive and more professional product
In a similar sentiment Martin Hanczaruk, general manager of Ferring, a local market leader in gastroenterology and in vitro
fertilization products, agrees with the room for growth and underestmation of Poland. "Poland is definitely underestimated,"
he asserts. "Poland is for Ferring the second country in the region after Czech Republic. Now, when comparing both populations,
it is easy to conclude on the growth opportunities for Ferring in Poland."
Unmet medical needs for diabetes marks a huge growth sector of the market for Novo Nordisk. Wojciech Kowalski, general manager
of the group's Polish affiliate, explains that market growth for diabetes is higher than in other European countries, largely
due to the fact that early detections systems have been weak over the past 10 years. He states: "Patients were put on quality
treatments based on insulin injections relatively late. In fact, there were years when half of the diabetic population was
not even diagnosed with this disease. Although there is still room for improvement, more and more patients with diabetes are
detected and adequately treated. That has increased the size of the market for diabetes tremendously throughout the years."
The Euro Consumer Diabetes Index, a publication provided by the Health Consumer Powerhouse, in 2008 rated Poland as the 25th country in Europe in terms of
care of diabetics in 2008. "That was quite low and shows the need for improvement of the healthcare services for diabetics
in Poland," says Kowalski.
Over the past 20 years Poland has been systematically breaking down walls for the betterment of its economy and society. The
effect of November 9, 1989, in Berlin rippled east, bringing down communist barriers in Poland and opening up markets in former
Soviet blocs. May 2004, brought down another barrier and incorporated Poland into a competitive, standardized European Union.
January 11, 2012, will be a major turning point, as that is the date the government will announce a new reimbursement policy
for pharmaceuticals. The period leading up to January is therefore marked by another wall that government and industry must
cooperatively surmount: a communication barrier between the two entities to cohesively determine the future of innovation
in the country. To date, a government that is noble in its commitment to manage costs and safeguard a robust economy is countered
by industrial innovators seeking greater access for life-altering medicines. Myriad signals about future legislation have
produced ambiguity and uncertainty in the market. As one executive manager expresses, which is consistent with the collective
voice of industry leaders, "I would be pleased if the relationship between the government and the pharmaceutical industry
would continuously improve through a constructive partnership with the ministries of health, economy, education, and research.
I am confident that this will happen." Poland's historic ability to break down walls and the prosperous future that a talented
workforce and rich scientific culture offer leaves little room to doubt the full awakening of this Eastern European giant.