PMR notes that the amendment to Poland's tax code, effective from December 1, will amend the list of "expert services" compiled under Article 27 of the country’s Goods and Services Tax Act and make clinical research taxable in the client's country, rather than Poland.
That should make operating the country less of a headache for contract research organisations (CROs) and pharmaceutical developers alike, as VAT would not be imposed on foreign companies, and CROs located in Poland could claim a refund.The situation in Poland has been confusing for contractors, with four separate categories under which CROs operate, some of which are Goods and Services Tax-exempt – attracting a value-added tax rate of 22 per cent - and some which are not. Complicating matters still further, individual tax inspectors have extensive freedom to interpret how a case should be categorised.
Despite the tax break, however, the lengthy and complicated procedure of trial registration with Poland’s CEBK (Central Register of Clinical Trials) remains the key barrier to the development of the clinical research market.
In 2007 the Polish clinical trial market- defined as Phase I-IV clinical trials and bioequivalence tests, totalled nearly PLN 630m (€167m), a rise of 10 per cent on 2006. PMR research published back in July suggested that the size of the market could increase to PLN 800m (€212m) in 2010, but said at the time this would only be possible “if the Health Ministry manages to implement less formalised requirements for submission of clinical trial applications before the end of 2009.”
Polish drug sector on the up?
Meanwhile, a new report from Research and Markets indicates that the Polish drug market as a whole will show “modest growth” out to 2012 as the government keeps tight control of the pharmaceutical budget.
To date Poland has kept its drugs bill down by restricting the number of new innovative medicines that receive reimbursement, relying instead on older generic drugs for many therapeutic categories.
That could change, the report suggests, as “favourable economic conditions are set to fuel increased healthcare spending over the next few years, which should hopefully transcend into slightly more liberal policies on innovative medicines.”
An increasing number of private hospitals - estimated to be around 150 at present -should also drive expansion of the drug market over the next five years, it said.