SIGNS OF STABILITY
To prevent dialogues from becoming monologues with a witness, strengthening public/private sector relations should be key
priority for pharmaceutical executives when deploying their investment strategies in Romania today. This is not an easy task
in a nation which has seen a new federal health minister nearly every year for the past 20 years.
Luca Visini, General Manager of Eli Lilly Romania
Referring to any kind of interaction at the level of the industry and the institutions as "contaminations," country general
manager Luca Visini of US giant Eli Lilly shares his view on successful cooperation strategies with authorities in Romania.
"I dedicate a lot of time to the partnership with the Ministries of Health and Education," he notes, "for example on awareness
programs for Attention Deficit Hyperactivity Disorder (ADHD). Essentially, it all comes down to allowing the aforementioned
'contamination.' From day to day, you may have converging interests with many different parties, including distributors and
technology suppliers. If this contamination leads to an increase in the standard of care or the usability of the products
you make available to the patients, this should be welcomed."
Walking the talk, Visini is justifiably proud of leveraging its stakeholder relations in Romania, holding 20% of the clinical
studies in the country today. "In 2009, out of the 288 requests for clinical trials, the national agency approved 233 studies,"
Visini states. "However, getting an approval mainly depends on what exactly the company is planning to do, the way it wants
to do it and what it is capable of putting on the table," he continues. "As long as we are able and successful at keeping
our level of standards high, there are generally no barriers to engage in clinical research. At the end of the day, clinical
trials are a sign of stability for a country. In our case, the investments in Romania imply that we are here and plan to stay
here. Maybe the government does not provide clear incentives to do clinical trials in Romania but I firmly believe that approvals
can be obtained if you do things the way they should be done," Visini concludes.
Steve Warner, Managing Director of MSD Romania
"I believe that you need to control what you can control. Regardless of what is going on externally, we can control our attitudes,
our discipline, our focus, and our interaction with our customers," argues Steve Warner, MSD's managing director for Romania.
When asked for the No. 1 driver for the American company to conduct clinical trials in the country, Warner instantly points
to the access to patients driven by a high level of unmet needs. "For instance," he explains, "we have started a Named Patient
Program for one of our new products, VICTRELIS, for the treatment of hepatitis C. On a global basis, around 300 patients have
been allocated to this program. Romania alone accounted for 200 of them. Everyone was very impressed that we could get 200
patients so quickly, which to a large extent is related to the huge unmet needs driven by the extremely high prevalence rate
of hepatitis C in Romania. There is a very large pool of patients that need this medicine, which outside of the Named Patient
Program could not have had access."
Budget constraints have restricted medicines access for Romanian patients, as the government became unable to update its reimbursement
list since 2008. "I understand that such revision is a challenge, but at the same time Romanian patients are being put at
a disadvantage because they do not have access to the same medications as many patients in other EU countries have," adds
While the unpredictability in the Romanian pharma landscape may be a challenge to the sector's strategic minds, the high level
of unmet needs and the sizeable patient base should be sufficiently convincing to justify investment for the long term. The
greatest oak was once a little nut who held its ground.