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Decree-Law n.º 48-A/2010 – New rules for medicines pricing

Last May 13, 2010, was published Decree-Law No. 48-A/2010 amending Decree-Law 195/2006 of 03-10, which sets the rules for prior evaluation of medicinal products reserved exclusively in hospitals, Decree-Law No. 65/2007, of 14-03, which establishes the Price Regime of Drug Administration and approves the new legal framework of the State in regards to the reimbursement of the price of medicines, revoking Decree-Law No. 118/92, of 25-06.

The main alterations that the law introduces are the following:

I - In the Decree-Law 195/2006 of 03-10:

  1. The process of evaluation of medicinal products must be directed with the study of economic evaluation, which must comply with the guidelines to be approved by the member of government responsible, with the exception of the generic medicines for which this report is not required;
  2. The deadline for release of the final decision by INFARMED IP, was extended from 45 to 60 days;
  3. A overruled decision is published on the INFARMED website and is no longer published in the Diário da República;
  4. The report on the effectiveness of therapy becomes annually, therefore should be sent to INFARMED in January of each year, for the previous year.
  5. Although the application for assessment of the medicine is overruled, exceptionally, in cases of absence of alternative therapy there may be authorization by INFARMED of access to this medicine.

 

II - Decree-Law No. 65/2007 of 14-03:

  1. The annual review of prices occur taking into account the prices practiced in the countries of reference to the date of January 1 of each year;
  2. The maximum margins for the marketing of medicines are standardized, by applying to the reimbursed medicines and non reimbursed medicines the margin of 8% for wholesalers, calculated on the selling price to the public, and 20% for pharmacies.

In regards to the last alteration it is important to empathize that, although Article 10 of the act in question, is expected that the entry into ruling would take place on 1st June of 2010, Article 9 stipulates that the provisions of Article 12. Decree-Law No. 65/2007, of 14-03, in other words, the last change described above, “shall take effect from the May 1, 2010.”
The new scheme of reimbursements of the State in regards to the price of medicines, besides being systematically tidier and more developed in relation to procedural rules, makes the following amendments, in relation to the repealed, Decree-Law No. 118/92 of 25 - 06:

  1. The request for reimbursement must be submitted electronically and does not have to be accompanied by the photocopy of the authorization in the introduction to the market;
  2. Investigation of the procedure is the responsibility of INFARMED, but the responsibility for issuing the decision rests with the Government member responsible for Health, and may also be delegated to the INFARMED, in regards to generic medicines;
  3. The responsible authority has 20 days to verify the reliability of the application and may grant the person interested 10 days to provide the information or clarifications required;
  4. The overruled injunction is expected, if they do not comply with the requirements of the request, which allows you to submit another request, correcting the deficiencies identified by the responsible authority;
  5. The  responsible authority continues to have a period of 90 days to issue a decision, reduced to 75 days in the case of generic medicines;
  6. The decision on the request  is notified electronically, as well as all other notifications of the procedure;
  7. The deadline for submitting the date of the commencement into the market remains, but this commencement must match the first day of each month;
  8. The revaluation of reimbursed medicines occurs when INFARMED understand that the technical-scientific development justifies, failing to obey the tri-annual periodicity;
  9. A forfeiture is introduced of the reimbursement, if within the six months, counting from the date of the approval notification of reimbursement, the applicant is not in the market within the SNS or ADSE or if after that date the medicine is not available in the market for more than 90 days;
  10. Specific rules are provided  for the reimbursement of generic medicines, namely that: starting from the 5th generic medicine, inclusive, the economic benefit advantage is achieved by the determination of the sale price to the maximum public, less than 5% of the maximum PVP of the generic medicine whose valid request for reimbursement is immediately preceding, and each AIM may only request a reimbursement from the State for a generic drug with the same qualitative and quantitative composition in active substances, and the same dosage and same pharmaceutical form;
  11. Still in regards to the generic medicine, when there exists a homogeneous group, the PVP of new medicines to reimburse must be less than 5% of the PVP of the generic medicine with PVP lower and with at least 5% market share.

With exception to what is given in purpose with the amendments to Decree-Law No. 65/2007, of 14-03, all other amendments came into ruling on 01-06-2010.


07-06-2010