GREECE Trends and Developments Contributed by: Ioannis Manousakis and Dimitra Panopoulou, ALG Manousakis Law Firm
The constitutionality of the “claw-back” mecha- nism has been repeatedly challenged. Pharma- ceutical companies challenged the implementa- tion of the claw-back before the Conseil d’ Etat on the grounds that it restricts their freedom to operate independently and restricts their finan- cial freedom. However, The Conseil d’ Etat ruled that these restrictions are constitutionally justi- fied from the public interest perspective in saving pharmaceutical costs and the long-term sustain- ability of the social security system. Regarding orphan drugs, the Conseil d’Etat, in its decision 162/2020, ruled that imposition of claw–back in orphan drugs is unconstitutional because these medicines constitute a special category, as they are used for the treatment of rare diseases and, furthermore, because they concern an extreme- ly small number of patients, who are already known in advance, compared to medicines used for the treatment of other severe diseases (ie, the government cannot impose budget restric- tions when the budget for those drugs should have been calculated due to the limited number of patients). Additionally, despite the fact that under Regulation 141/2000, EU member states must provide incentives to encourage the circu- lation of these medicines, Greek legislation on automatic reimbursement does not provide any form of special treatment for these medicines. As a result, the consequences become dispro- portionate to the intended purpose of the state in reducing pharmaceutical expenditure and, for this reason, constitute an excessive restriction on the companies that market orphan drugs. In order for the Greek government to mitigate the financial impact of the “claw-back” mecha- nism and promote research and development (R&D), it enacted Law 4633/2019, which allows pharmaceutical companies to offset the amount of the claw-back with eligible R&D and invest- ment expenses. The Joint Ministerial Decision
4577/24-1-2020 sets out the procedure and specific terms and conditions under which the claw-back obligation may be offset with R&D expenses for the development of pharmaceu- tical products. The amounts owed under the claw-back provisions may be offset with R&D expenses, including preclinical and clinical trial expenditures for original products. In 2020, the total amount available for offsetting was EUR50 million and in 2023, it was EUR150 million. The inclusion of this measure in the RRF aims to promote investments and create a favourable environment for innovation in Greece’s pharma- ceutical sector. This is the first time that such a law has been implemented, providing investment incentives for pharmaceutical companies while ensuring fiscal responsibility in public healthcare spend- ing. This initiative aims to stimulate research and development, foster innovation in the pharma- ceutical sector, and ultimately improve public health outcomes. Increase in the use of generic pharmaceutical products Greece was one of the bottom countries in the European ranking of generic drug use in 2010, where only 15% of the medicinal products sold were generic or biosimilar products. Following extensive changes in the legislation, a sustained and steady increase in the use of generic medi- cines has been observed from 2010 to 2022, and the total consumption reached 32.6%, with an increase rate of 8.5% during 2022. In Greece, until the outbreak of the fiscal crisis at the end of 2009, pharmaceutical expenditure was unsustainable due to legislation reimburs- ing any brand-name drug. Following the sign- ing of the First Memorandum and the First Economic and Financial Adjustment Program
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