The defendants have appealed the decision to the Romanian courts, arguing that it was the tax, not the joint lobbying activities, that caused the limitation of supplies in the Romanian market.  These appeals have now reached the Romanian High Court of Cassation and Justice (HCCJ), which has requested a preliminary ruling from the Court of Justice of the European Union (CJEU) to clarify the legal standard and burden of proof in these circumstances.

The Clawback Tax & Joint Lobbying

In Romania, a legislative change made pharmaceutical companies subject to a “clawback tax,” a fiscal mechanism requiring medicine manufacturers to cover the deficit between the state’s medicine budget and actual medicine consumption. The suppliers of human immunoglobulins—Baxalta, CSL Behring, Biotest, Kedrion, and Octapharma—argued that this tax made the commercialisation of their plasma-derived products economically unsustainable. According to the companies, the tax would have resulted in inevitable losses on every unit sold in Romania.

To address this issue, the companies engaged in joint advocacy efforts through the “Romania Task Force” (ROTF), a working group established under the Plasma Protein Therapeutics Association (PPTA). The companies made submissions to the Romanian authorities explaining that the tax would force them to operate at a loss and that a withdrawal from the Romanian market was an inevitable economic consequence, unless an exemption was granted.

The Competition Investigation, Decision & Appeal

Following an investigation launched in 2018 with inspections in Belgium, Italy, and Romania, the RCC issued a decision in 2021 claiming that the companies’ actions went beyond legitimate lobbying and advocacy. The authority stated that the companies and the PPTA engaged in a concerted practice to intentionally limit and interrupt the supply of immunoglobulins to the Romanian market. According to the RCC, this coordination was designed to pressure the government into suspending the clawback tax and improving the companies’ profit margins.

The defendants challenged the decision before the Romanian courts.  In July 2024, the Bucharest Court of Appeal dismissed the action brought by Kedrion, which subsequently appealed to the HCCJ. On 27 November 2025, the High Court stayed the proceedings to refer two questions to the CJEU on the application of EU competition law (case C-793/25):

New Questions to the EU Court of Justice

• If it is economically certain that the tax will force the companies to exit, does jointly discussing this fact constitute a competition law violation? Can Article 101 TFEU be interpreted as meaning that it does not cover alleged conduct adopted in a context in which there is no uncertainty in the market, that is to say, that the concept of concerted practice excludes correspondence within a trade association regarding an additional tax obligation imposed on the industrial sector to which the association’s members belong, in circumstances in which such correspondence, relating to the known effects of the tax obligation, cannot be regarded as reducing the degree of uncertainty inherent in the normal competitive environment?
• Who bears the burden of proof?  Can Article 101 TFEU, the rights of defence and the principle of the presumption of innocence, enshrined in Article 48 of the Charter of Fundamental Rights of the European Union, be interpreted as meaning that, in order to adequately meet the burden of proof, a competition authority is required to dispel, in an explicit, reasoned and substantiated manner, any doubt as to the existence of a concerted practice, where one of the members of the trade association demonstrates that there is an alternative explanation for the withdrawal of its products from the market?

Implications

The CJEU’s answer will be significant to companies operating in the pharmaceutical sector, where European governments often unilaterally impose taxes or other measures that impact the financial viability of continuing supplies to the market.  It is important that pharmaceutical companies remain able to engage in collective advocacy to inform public authorities of the economic consequences of legislative or regulatory measures, to convey the industry’s perspectives, and to submit factual information.  Competition authorities should not intervene against such activities unless there is clear evidence that any alleged reduction of supply in the market is the result of anticompetitive activities, and not the result of a tax increase that forces companies to operate at a loss.