- The Government represented by the Ministry of Health and Ministry of Finance, rejected any proposal made ??by the delegates of the representatives companies of Generic Drug Manufacturers Association from Romania, ignoring economic and social effects of extremely serious charge that it produces;
- The Generic manufacturers, most of them having production unist in Romania, have no other choice but insolvency or re-evaluating its product portfolio: hundreds of affordable medicines is likely to disappear from the market;
- APMGR asks IMF and the European Commission to decide on the imposing public clawback tax in its present form in the context of the serious effects it can have on the health state of the population of Romania.
BUCHAREST, 26TH JUNE 2012 – The member companies of APMGR announced that the discussions with Government for revising clawback tax have failed, as authorities rejected any proposal issued by representatives from the industry of generic medicines.
“We can no longer take part in discussions where just one voice is heard and where the only interest is financial, and where the highly serious effects at social and economical level are ignored” stated Laurentiu Mihai, Executive Director APMGR. “We request one more time the personal involvement of Prime Minister Victor Ponta and the Minister of Public Finance Florin Georgescu for unblocking this situation”, added Mihai.
Under the premises that the Government’s main argument on keeping the tax in its present version is obeying the agreement with The International Monetary Fund and European Commission the member companies of APMGR requested from the two institutions to publicly formulate their point of view on keeping the clawback tax in its present version. “We refuse to believe that IMF and EU back up a solution which leads to limiting the access of Romanians to medicines and destroying the local pharmaceutical industry,” declared Mihai.
Generic drug manufacturers are the most affected as a result of applying this tax. Despite the fact that they play an important role in the economy – per total their activities offer 8000 jobs in Romania and bring an important contribution to public finance by direct and indirect taxation. Insolvency of these producers is the end of Romanian pharmaceutical industry.
For most generic medicines producers avoiding insolvency may be done only by revising the product portfolio, renouncing those reimbursed medicines which due to the level of clawback tax reached below the break-even point. To give a clear image of the severity of this situation APMGR asked the market research company CEGEDIM to identify the first 100 medicines which risk to disappear from the market because of the applying the clawback tax in its present version. The list of the 100 medicines is annexed to the press release.
The member companies of APMGR continue to support the following principles in obtaining a claw back tax sustainable by the industry.
The tax must be predictable and capped at a realistic maximum value and accessible to the generic drugs producers.
- Using the claw back mechanism for controlling the disproportionate increase of drugs sales and not for covering the public budget deficit.
- The calculation base of the tax must be the sale price of the producer, not the shelf price.
- The real consumption from the previous year must be the reference amount used in calculating the tax.
- The payment terms should be correlated with reimbursement terms – a clearly defined of reducing these terms to maximum 60 days.
Moreover, the application of a new clawback tax must be done only after a review of the calculation for the first two semesters of 2012.