By means of Royal Decree 8/2014 (February 7 2014), Spain has implemented EU Directive 2011/24/EC (March 9 2011) concerning transborder health assistance to be provided to patients.
The decree's regime coexists with the rights contemplated in EU Regulation 883/2004 (April 29 2004) and EU Regulation 987/2009 (September 16 2009). While the latter regulates the social security rights of EU citizens (including nationals of third countries residing legally in the European Union, as well as stateless individuals and refugees) when staying in another EU country, EU Directive 2011/24 (and the royal decree which implements it in Spain) regulates the conditions in which a patient may receive healthcare in a country other than the country of his or her residence.
The following services are excluded from the scope of the decree:
- long-term care services intended to aid persons requiring assistance to carry out daily routine tasks;
- assignation of organs and access to organs for transplant purposes; and
- certain public vaccination campaigns addressed specifically to people in Spain.
Health services subject to the decree may be provided by public or private health services providers. The cost of assistance is paid for by the patient, who is then reimbursed up to the amount that would have been taken by the administration if assistance had been provided in Spain. The services for which reimbursement is provided must be covered in the country of origin.
Authorisation is not generally required, except for some services specified in Annex 2 of the decree, which includes:
- overnight hospital stays; and
- certain treatments requiring highly specialised proceedings, equipment or complex patient care at a high cost.
Article 17 of the regulation includes the following grounds for refusal of authorisation:
- The service for which assistance abroad is requested is not included among those services provided by the National Health System;
- It is deemed that the service requested will expose the patient to unacceptable risks; and
- The healthcare assistance to be provided abroad may be provided in Spain within a medically justifiable timeframe resulting from an individual clinical evaluation on a case-by-case basis.
The regulation also provides for the recognition in Spain of medical prescriptions issued in another EU member state to a patient for medicines whose commercialisation is authorised in Spain (except medicines subject to special prescription, eg, narcotics). Such prescribed medicines will be delivered in Spain unless the pharmacist has reasonable doubts as to the authenticity and validity of the prescription. The regulation specifies a minimum content for prescriptions, which includes:
- identification of patient;
- date of issuance;
- identification of health professional issuing the prescription; and
- data identifying the medicine or health product.
Moreover, with regard to identification of the medicine, if the prescription concerns a biological medicine, the regulation requires that the trademark be specified in the prescription rather than the name of the active ingredient (a matter contemplated in EU Directive 2012/52/EC, which enforced EU Directive 2011/24/EC). This provision establishing the prescription by trademark has reactivated discussions in connection with the legal regime applicable in Spain to biosimilar medicines. The Medicines Law (July 26 2006) acknowledges that, unlike in the case of generics, biosimilar medicines are not automatically interchangeable for dispensing purposes (Article 86.4 of the Medicines Law and Order SCO/2874/2007). However, biosimilar medicines receive the same treatment as generics for the purposes of establishing a reference price. Under Article 93 of the Medicines Law and the recently enacted Royal Decree 177/2014 (March 21 2014), it is possible to create a group of medicines and set forth a reference price (the maximum amount to be reimbursed by the administration) for the medicines included in that group when there are at least two products with the same active ingredient and the same method of administration and one is a generic or a biosimilar medicine (for further information please see "Developments in reference pricing system"). It has been argued that no similar treatment on prices is justified if the biosimilar medicines are not interchangeable.
Further, in general the legal framework applicable to biological medicines is confusing and occasionally contradictory. For example, according to the Medicines Law, if a product is prescribed by active ingredient, a pharmacist must dispense the product which has the lowest price within the same homogeneous group and, if the price is the same, the generic or biosimilar product within that homogeneous group. However, no prescription by active ingredient applies to biological products and they should not be part of homogeneous groups, since the requirement for that category is interchangeability. In this respect, the pharmaceutical industry has pushed for a clearer legal framework regarding biological medicines.
In connection with the reference price system, according to Royal Decree 177/2014, the authorities have disclosed the draft of the new regulation which updates the existing groups of medicines with a reference price, and adds new groups to which a reference price is given and eliminates others. The criteria used for the creation of the groups, as well as the prices shown in the draft order, have already caused controversy. The new order is expected to be approved imminently. The effect that it may have on the industry will not be seen until the final text is approved by the authorities.
For further information on the this topic please contact Jorge Llevat at Cuatrecasas Gonçalves Pereira by telephone (+34 93 290 55 00), fax (+34 93 290 55 67) or email (firstname.lastname@example.org?). The Cuatrecasas Gonçalves Pereira website can be accessed at www.cuatrecasas.com.