• Generic medicine producers that do not benefit from the introduction of new molecules on the list, would be severely affected by an unfair tax burden, with serious consequences for patient access to affordable treatment.
  •  The strict criteria introduced by the Ministry of Health in the draft Order approving criteria for health technology assessment (“HTA”) are a guarantee that only those drugs that bring something new from a medical point of view, will be compensated

BUCHAREST, 30 MAI 2013 – The Association of Generic Medicine Producers from Romania (APMGR), an association that represents the interests of the main investors present on the Romanian market, believes the clawback tax cannot be a solution to funding the introduction of new medicines in the reimbursement system, given that this fee can only be regarded as a temporary mechanism to cover funding gaps in the health system.

Moreover, with the introduction of new drugs, the enforcement of the tax in a unitary way would seriously affect generic medicine producers, which do not benefit from the introduction of new molecules on the list, and would result in the disappearance from the market of affordable medicines. According to APMGR’s estimates, the introduction in the reimbursement system of the medicines currently on the waiting list, will determine an additional consumption of 500 million RON/year, which will prove difficult to control in the context in which the value of the unpaid medicines for 2011-2012 is 3 billion RON. APMGR’s representatives will continue discussions with the Ministry of Health in order to put in place a fair clawback tax that can provide access to pharmaceutical treatment to the population, while also assuring financial efficiency.

In order to increase the population’s access to innovative treatments, APMGR believes the evaluation criteria for assessing medical technologies (“HTA”) in Romania, currently in a public consultation process, are extremely important. Following discussions with the Ministry of Health, APMGR believes that the proposed project has a set of criteria that can provide an objective, scientific, transparent and non-discriminatory evaluation of the new medicines proposed to be registered in the Romanian reimbursement system, which are, in fact, part of the commitment assumed by the Romanian Government before the IMF, in its previous letters of intent.

A set of criteria, which choose for compensation only those medicines that really bring something new from a medical point of view, while also providing budgetary efficiency, offers the guarantee of sustainability to the public health system” said Dragos Damian, president of APMGR.

We really appreciate the discussions and the progress made so far in developing the methodology for HTA system and the commitment assumed by the Ministry of Health to correct the calculation mechanism for medicine’s prices and the clawback tax, so that the generics industry is not required to pay for additional consumption determined by the introduction of new molecules in the Romanian reimbursement system, ” added Damian.