Statement on Romanian Competition Council

To our big surprise representatives from the Romanian Competition Authority arrived at our offices in Brussels on June 26 and were joined by Belgian police and the Belgian Competition Authority. The investigators were interested to know whether there was a coordinated effort to restrict supply of immunoglobulin therapies to the Romanian market for the purposes of pressuring the government to exempt these therapies from the “claw back” tax. PPTA cooperated fully with the investigators.

PPTA takes its commitment to patient access seriously. Nothing is more troubling than when patients do not have access to life-saving medicine because a government does not recognize that immunoglobulin therapies are very different from traditional pharmaceuticals. Unilateral reimbursement policies that fail to recognize the value of immunoglobulin are detrimental to patient access. PPTA has long maintained that reimbursement must be adequate to ensure patient access.

The immunoglobulin access situation in Romania has been challenging. This caused many reactions in the patient community, and even questions were raised by Romanian Members of the European parliament.

Following a period of collaborative advocacy by PPTA and patient groups with the relevant government agencies, the Romanian government agreed in December 2017 to a two-year exemption from the claw back tax for plasma protein therapies, beginning January 1, 2018. PPTA believes that this is a big step in the right direction and that the exemption should be made permanent.

PPTA remains steadfast to its mission to promote the availability of, and access to, safe and effective plasma protein therapies for all patients. PPTA complies with all laws and regulations governing competition.