PPTA Disagrees with Ruling from Romanian Competition Council

The Plasma Protein Therapeutics Association (PPTA) disagrees with the 15 February 2022 ruling from the Romanian Competition Council (RCC) finding that PPTA directed manufacturers to withhold immunoglobulin (Ig) therapies from the Romanian market to force repeal of the so-called “clawback” tax. This conclusion is not supported by the RCC’s own investigation, which produced no evidence that company withdrawals from the Romanian market were the result of anything other than independent business decisions.

PPTA further notes that the RCC’s theory that the two-year suspension of the claw-back tax was driven by pressure from a PPTA-facilitated boycott is contradicted by the fact that, though PPTA has had no activities of any kind in Romania since the Competition Council launched its investigation in 2018, repeal of the claw-back tax for plasma-derived medicals products (PDMPs) was made permanent in 2020.

PPTA takes its commitment to patient access seriously and maintains that one-size-fits-all reimbursement policies, like Romania’s pre-2018 clawback tax, fail to recognize the value of PDMPs and are detrimental to patient access. PPTA has long argued that PDMPs are fundamentally different from chemical pharmaceuticals and that their uniqueness should be reflected in any patient-focused reimbursement framework.

PPTA complies with all laws and regulations governing competition and remains steadfast in its mission to promote the availability of, and access to, safe and effective plasma protein therapies. With respect to the RCC’s ruling, the Association is considering all options, including appeal.


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