Last year the pharmaceutical market in Romania reported sales of 2.63 billion euros, 3.1% more than in 2011, according to a survey by the market analysis company Cegedim Romania. The survey also expects a drop in the value of sales expressed in euros, while noting that the difficulties on the market have started to affect even the strongest companies.
Overall forecasts for 2013 are modest, with an expected 1.4% rise in sales expressed in lei being most likely tantamount to a drop when it comes to sales expressed in euros or dollars. Last year’s increase in terms of lei stood at 8.3%, a little less than the Cegedim forecast of 8.9%, the market value standing at 11.71 billion lei. The Cegedim survey also shows that the market is negatively affected by measures to reduce state subsidies and extend payment deadlines, which means that fewer patients will be able to continue their treatment as before.

Increases in euros stood at 2.6% to reach 2.27 billion euros in the case of pharmacies and 6.4% to reach 356 million euros in the case of hospitals. The value of prescribed medicines sold on the market was 1.8% higher than in 2011, to reach 1.89 billion euros, while that of over-the-counter drugs increased by 6.6% to reach 375 million euros. The ten biggest companies in Romania in terms of sales include the Bucharest based company Zentiva, which holds the first position, followed by Hoffman La Roche and Novartis, as well as GlaxoSmithKline, which owns the Europharm factory in Brasov, in the centre, Servier, Pfizer, AstraZeneca, Merck&Co, Ranbaxy, which owns the Terapia factory in Cluj Napoca, and Abbot.

The 11-20th positions are held by several companies, such as the state-owned Antibiotice Iasi, then KRKA, Johnson&Johnson, Teva, Bristol Myers Squibb, Menarini, Bayer or Labormed Bucharest, the latter being recently purchased by the US company Alvogen. Next come Eli Lilly and Gedeon Richter. Doctor Sorin Paveliu, president of the Romanian Pharmacoeconomy Society told us more about what was going to happen on the pharmaceutical market.

Sorin Paveliu: ”I do not expect major withdrawals from the market as this is not the way multinationals operate; investment in promotion and sale infrastructures for various medicines cannot be withdrawn overnight. They are facing some irregularities, such as the lack of predictability or loss-making changes they need to explain to shareholders. So, predictability is what they actually need; there will be no market widrawals, but things are going to get tough for small players, which are presently taking the brunt of those excessive measures, such as the decision to set the smallest price or the clawback tax. All those measures can put the small players under their profitability threshold and maybe it’s better for them to pull out of the market, at least temporarily.”
Recently, Romania’s Constitutional Court has partially eliminated a surcharge through the so-called clawback tax, under which they have to return part of the revenues to the state budget, if these revenues exceed a certain amount previously set under the law.

The Constitutional Court has ruled the clawback tax as partially unconstitutional since medicines are subjected to a double taxation, by including the VAT.

Dragos Damian, chair of the Association of Generic Medicine Producers in Romania, believes the clawback tax had to be replaced because it was a fiscal error. He warns that there are still pending issues related to that tax.

Dragos Damian: „We pay this tax for incomes made by third parties, such as distribution networks and drugstores. The tax is levied on quarterly incomes, but we cash in money from those sales after a year. That’s why we, producers of generic drugs have come with a suggestion, that cheap medicine, under 5 euros, be exempted from the clawback tax, so that they may not disappear from the market.”
In turn, Sorin Popescu, head of the Communication Office of the aforementioned association told us that in this way patients would no longer be affected by the clawback tax.
Sorin Popescu: ”Patients may be affected by various other issues, such as the lack of subsidized medicines, as these subsidies haven’t been updated in the past five years. But as far as I know, the government is working on that and we hope the Health Ministry will quickly come up with a solution to all those issues so that we may have subsidized medicines in Romania, like elsewhere in Europe.”

Medicine producers believe that a new formula of levying the clawback tax will allow companies to invest in production and effectivelly use these incomes. Source; Radio Romania International