PORTUGAL Trends and Developments Contributed by: Margarida Roda Santos, Paulo Sampaio Neves and Mariana Pereira Dias, Eversheds Sutherland
to allow new models for costing and financing healthcare, particularly the NHS, to be studied and implemented. The balance between ensur- ing that innovation is possible while regulating the sector is an issue that the European Union will increasingly face in the future. Another challenge related to the VBH financing model is its compatibility with public procure- ment, since in Portugal this sector is very rigid, and there are doubts and difficulties regarding how to operationalise a VBH-based payment model in the context of public procurement. In Portugal, some pilot projects introducing val- ue-based payments models have already been implemented. A white paper published by Health Cluster Portugal in June 2023 even refers to the crucial role that the legislator and the govern- ment have in developing legislation to encour- age healthcare providers to focus on improving treatment outcomes. To integrate the VBH financing model, several regulatory changes, both in Europe and in Portu- gal, would be desirable; even though it is already possible to implement VBH projects, there are difficulties and uncertainties related to the exist- ing legislation. The European Union is currently harmonising the various regulations in this area, but each European jurisdiction will also have to individually adapt its health systems. In sum- mary, the VBH model will certainly see strong growth in the coming years. Extraordinary contribution to the pharmaceutical industry Another pressing issue in the health area that the pharmaceutical industry hopes will soon be addressed by the regulators in Portugal concerns a concept introduced by Law No 82-B/2014 of 31 December (the “2015 State Budget Law” ),
namely “extraordinary contribution to the phar- maceutical industry” , with the ultimate aim of financing the NHS. Extraordinary contribution to the pharmaceutical industry is predicated on the sales of medicines in Portugal. The contribution varies between 2.5% and 14.3% and is calculated according to the total value of sales of: • medicines reimbursed by the state; • medicines subject to prescription restrictions; • medicines with exceptional use authorisation or exceptional authorisation; • medical gases and derivatives of human blood and plasma; • other medicines whose packaging is intended for hospital use; and • orphan drugs. It transpires, however, that this contribution was provisional, yet the regime has been included in all successive state budget laws for more than ten years. The extraordinary contribution to the pharma- ceutical industry regime is applicable to entities that make the first sale of medicines for human use in Portugal. These entities include: • holders of marketing authorisations or regis- trations; • representatives, intermediaries and wholesale distributors; and • marketers of medicinal products under exceptional use authorisation or exceptional authorisation. However, the law provides for the possibility of an agreement between the Portuguese state and the pharmaceutical industry – through the Portuguese Association of the Pharmaceutical
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