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Legal alert no. 42

New rules regarding the Nacional System of Evaluation of Healthcare Technologies (SiNATS)

On the past September 7th, it was published, in the Portugal Official Gazette, the Decree-Law no. 115/2017, which amends, for the first time, the Decree-Law no. 97/2015 dated from June 1st, which established the Nacional System of Evaluation of Healthcare Technologies (SiNATS), that evaluates medicines and medical devices, for purposes of deciding if they can be used under the National Health Service (NHS) and be co-payed by the State.

This Decree-Law settles new definitions, such as “homogeneous group of generic medicinal product”, “homogeneous group of similar biological medicinal product” and “similar biological medicinal product existing in the market”. In addition, the rules regarding to co-payment of similar biological medicinal products are amended. It is stressed the reduction of the price of the biosimilar medicinal products, which, in order to be financed under the NHS, are required to cost 30% less than the original biological, provided that biosimilar of the same active substance already exist in the market.

The Decree-Law no. 97/2015 dated from September 7th also clarifies the rules regarding the settlement of medicines’ and medical devices’ prices.

Additionally, this Decree-Law settles rules for authorization requests for exceptional use of medicines. The authorization for the exceptional use of medicines may be requested by hospitals, under special circumstances, in case of inexistence of alternative treatment and if the patient’s health condition is considered critical; being the provision of these medicines made under the “Early Access to Medicines Program”.

This decree entered into force on the past September 8th.

To access the complete text of the Decree-Law no. 115/2017, dated from September 7th, please go to - https://dre.pt/application/conteudo/108113700.

Afterwards, and concerning SiNATS, on September 12th it was published, in the Portugal Official Gazette, the Ministerial Order no. 270/2017, which amends, for the first time, the Ministerial Order no. 195-A/2015, dated from June 30th, which approves the common procedure of co-payment and previous assessment of medicines; and the Ministerial Order no. 271/2017, which amends, for the first time, the Ministerial Order no. 195-B/2015, dated from June 30th, that rules the settlement of homogenous groups for purposes of co-payment under the reference prices system.

The amendment to the Ministerial Order no. 195-A/2015, dated from June 30th, results from the amendment to the above mentioned Decree-Law no. 97/2015, dated from June 1st (further to the Decree-Law no. 115/2017, dated from September 5th). Thus, the Ministerial Order no. 270/2017, dated from September 12th, adjusts the common procedure of co-payment and previous assessment of medicines to the amendments made by Decree-Law no. 115/2017, dated from September 7th.

Instead of what was foreseen under the Ministerial Order no. 195-A/2015, dated from June 30th, the pharmacotherapeutic assessment opinions are now sent to the “Pharmacy and Therapeutics National Commission” (CNFT) solely to its knowledge. Therefore, the CNFT does no longer issue any decision over the inclusion or non-inclusion of medicines in the National Form of Medicines.

On the other hand, the decision of co-payment and the previous assessment of similar biological medicinal products has now to be issued under the same 30 days term as the generic medicinal products; and a term of 180 days was established for the medicines which international common denomination or therapeutic indication is not yet co-payed or which do not have an authorization for use in the institutions and services of the Ministry of Health, under a previous assessment. The decision of co-payment and the previous assessment have to be notified to the CNFT.

Finally, it should be noted that, due to the amendments made to Decree-Law no. 97/2015, dated from June 1st, the officious assessment or re-assessment may occur for purposes of public health, in addition to the other previous cases referred by Decree-Law no. 97/2015, dated from June 1st.

The amendment to the Ministerial Order no. 195-B/2015, dated from June 30th, results from the market development and aims to contribute to the NHS’s sustainability. Thus, the Ministerial Order no 271/2017, dated from September 12th, reviews the criteria for settlement of the reference price.

Additionally, the law frames the existent homogenous groups that were restored as a result of the reintroduction in the market of certain generic medicinal products, regarding the deadlines for the publication of the lists of homogenous groups, as well as the deadlines for the approval and publication of the reference price.

Both the Ministerial Orders no. 270/2017 and no. 271/2017 entered into force on the past September 13th.

To access the full version of the Ministerial Order no. 270/2017 and the Ministerial Order no. 271/2017, please go respectively to - https://dre.pt/application/file/a/108132149 and https://dre.pt/application/file/a/108132150

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