Ministerial Order SSI/1225/2014, which was approved on July 10 2014 and published in the Official State Gazette on July 15 2014, develops the new reference price system for medicines which was established by Royal Decree 177/2014 (for further details please see "Developments in reference pricing system").
The order was approved by the Ministry of Health following a lengthy deliberation process involving pharmaceutical laboratories, which voiced their disagreement with the proposed regulation. However, it was enacted without major modifications.
The order directly affects the prices and terms of public financing of medicines by the National Health System (NHS). It creates reference groups, comprised of branded or innovative medicines together with generic and biosimilar products with a similar active ingredient and an identical way of administration, as set out by the decree, and sets the reference price (the maximum amount of financing received by a medicine under the NHS) for each product included in the group. In setting the new groups and reference prices, the order implements the decree, which sets out the principles governing the creation of the reference groups (eg, the medicines in the group must actually be commercialised), as well as those governing the calculation of reference prices (eg, basing the price on the lowest cost or a minimum threshold price of €1.60).
One of the most controversial issues addressed by the order (and by the decree, which sets out the framework developed by the order) is the creation of reference groups for biosimilar medicines. These groups receive the same treatment as generic medicines. Aside from the economic impact of the creation of such groups in cases where there is a biosimilar product, the regulation has been criticised on the following grounds:
- For the purpose of creating the groups, biosimilar medicines receive the same treatment as generics, when in fact it is impossible to think about a similarity in the active substance of biological products;
- No parameters to determine a comparable defined daily dose for biosimilar medicines have been set; and
- Biosimilar medicines are not interchangeable.
Regarding the last point, interchangeability is a feature required for medicines to be part of a homogeneous group, but is now not a legal requirement for creating a reference group. In other words, unlike in the case of homogeneous groups, it is possible to include in the same reference group non-interchangeable medicines (ie, medicines that could not be replaced by others when being dispensed to a patient).
One explanation for the different treatment of homogeneous groups and reference groups is that they are different and operate at different levels. Reference groups are established to determine (and reduce) the maximum price of medicines under public financing from the NHS. However, the reference price system is irrelevant to the dispensation of medicines to patients; the homogeneous groups operate at the dispensation level (eg, groups of financed medicines, dispensed in pharmacies and with the same active principle, dose, content, pharmaceutical form and method of administration, which are interchangeable). For homogeneous groups, a lower price is determined by the authorities based on the lowest product price (revised every quarter), and thereafter there is the possibility for the voluntary reduction of prices. This system offers an incentive to reduce prices since the law also requires pharmacists to favour the dispensation of medicines in the homogeneous group with the lowest prices.
The configuration of the reference groups is another controversial aspect of the order. In this regard, it is claimed that the ministry has configured some reference groups with medicines that have different active substances, which is contrary to Section 93(2) of the Medicines Law (93/2006) and Section 3 of the decree, which provide that medicines of the same reference group must have the same active substance.
The order has introduced an important reduction in reference prices and, as a result, has applied pressure with regard to medicine prices, which must now be lowered to reach the reference price.
Some pharmaceutical companies have failed claims against the order. Further, since the current regulation dealing with biological and biosimilar products is only partial and occasionally contradictory, in June 2014 the Congress Health Commission approved a non-legal proposal calling on the government to issue a specific regulation in this matter.
For further information on the this topic please contact Jorge Robles at Cuatrecasas Gonçalves Pereira by telephone (+34 952 062 733), fax (+34 952 062 735) or email (email@example.com?). The Cuatrecasas Gonçalves Pereira website can be accessed at www.cuatrecasas.com.