Background
Amendments introduced by Royal Decree 782/2013
Amendments introduced by Royal Decree 870/2013
Comment


Background

Amendments were recently introduced to the Medicines and Sanitary Products Act (29/2006) in order to transpose EU Directives 2011/62/EC and 2010/84/EC - which deal with the prevention of entry into the legal supply chain of falsified medicinal products and pharmacovigilance - into national law (for further details please see "Medicines and Sanitary Products Act amended and new pharmacovigilance decree"). The changes were contained in Act 10/2013, which introduced amendments to the act, as well as in Royal Decree 577/2013, which dealt with the amendments relating to pharmacovigilance.

Furthermore, in September 2013 Royal Decree 686/2013 continued the transposition of the directives into Spanish law by introducing further post-authorisation obligations and more transparency and publicity requirements regarding the medicines themselves (for further details please see "Further amendments to medicines and sanitary products regulation").

Further developments have now taken place, in the form of Royal Decree 782/2013 on the distribution of medicinal products for human use(1) and Royal Decree 870/2013 governing the distance sellling to the public of medicinal product for human use.(2)

Amendments introduced by Royal Decree 782/2013

Royal Decree 782/2013 supersedes the previous provisions on the distribution of medicinal products for human use, which were set out by Royal Decree 2259/1994.

Royal Decree 782/2013 introduces the regulation of two new parties:

  • persons brokering medicinal products, through the creation of a register and the imposition of new obligations in light of the directive; and
  • wholesale distributors in free trade zones or free warehouses, which should comply with the provisions applicable to wholesale distributors in general (ie, authorisations, obligations, requirements).

Each distributor must now have a certificate stating that it complies with the Good Distribution Practices (GDPs) published by the Ministry of Health. The preamble to Royal Decree 782/2013 explains that the drafting of the GDPs is in line with European Commission policy.(3) On March 8 2013 the revised text of the GDPs was published in the Official Journal of the European Union and the GDPs came into force on September 8 2013 (ie, one month before promulgation of Royal Decree 782/2013).

In order to comply with the requirement of EU Directive 2011/62/EC that the introduction of falsified active ingredients to the market be avoided, Royal Decree 782/2013 reinforces the verification requirements with regard to the manufacture and import of medicines, in relation to the inclusion of new requirements for distributors. The amendments include the modification of Royal Decree 824/2010, which regulates pharmaceutical laboratories, manufacturers of active ingredients for pharmaceutical use and the external medicine and experimental medicine market.

Royal Decree 782/2013 extends the requirements to sell medicines directly to sanitary professionals for humans (Article 2.5 of Act 29/2006, which was introduced through Act 10/2013) to sanitary professional for vets.

Amendments introduced by Royal Decree 870/2013

Royal Decree 870/2013 governs the sale at a distance to the public of non-prescription medicinal products for human use (also known as over-the-counter (OTC) medicines). This regulation transposes Articles 85quarter and quinques of EU Directive 2011/62. This is the first development in Spain of sales at a distance to the public of medicinal products for human use. Such sales were mentioned in Act 29/2006 (Article 2.5, in connection with Articles 19.4 and 84.1), as well as in Act 34/2002 on the information society and e-commerce services (the Second Additional Provision), but their development was pending.

Royal Decree 870/2013 refers only to non-prescription medicinal products for human use or OTC medicines. In this regard, the following products are outside its scope:

  • prescription medicines;
  • medicines prepared in pharmacies;
  • unauthorised medicines; and
  • veterinary medicines.

If a pharmacy plans to commence online activity, it must inform the competent authority of the autonomous community in which the physical pharmacy is established at least 15 days before the start of such online activity.

The decree also requires the full identification of the pharmacist and the customer.

The decree establishes strict standards to ensure that customers are fully informed regarding the medicines that they buy, as follows:

  • The pharmacist must provide personalised advice, identical to that that which would be provided in a physical pharmacy.
  • The website should include the information included in the leaflet of the medicine.
  • The website must neither offer nor include links to self-diagnosis or self-treatment tools.
  • The delivery of the medicine must be accompanied by the information necessary to enable the customer to use the pharmacist's pharmaceutical care service.
  • Using the contact information provided for the order, the pharmacist may consider additional information about the customer that he or she considers relevant to guide, advise and instruct on proper use of the medicine. Further, the pharmacist should ensure that the customer receives adequate information and should answer requests for information on use of the delivered medicine.

The decree introduces requirements to ensure the correct transportation of the medicines – for example, where such transportation is carried out by a third party, an agreement between the pharmacist and the third party setting out specific provisions regarding each party's liabilities, the terms of the service and the protection of personal data must be signed.

In order to avoid the parallel import, misuse or abuse of medicines, the pharmacist should evaluate the appropriateness or otherwise of dispensing the medicines requested, especially when the required amount exceeds that used in standard treatments, or the requests are frequent or repeated.

The pharmacy website should include several links to official information and the EU official logo (pending approval).(4)

The Spanish Medicines and Sanitary Products Agency will rule on and publish special conditions or limitations on the distance selling of certain OTC medicines. Further, such sales are subject to the same conditions as sales at physical pharmacies.

Royal Decree 870/2013 provides for the sale of OTC medicines to individuals in a member state other than Spain by pharmacies established in Spain. However, this regulation does not mention online sales of OTC medicines made by pharmacies established in a member state other than Spain to individuals in Spain.

Comment

Further changes to Spanish pharmaceutical law are expected. The Ministry of Health is developing other new regulations, such as a royal decree to govern the pricing reference system and the homogeneous clusters in the National Health System.

For further information on this topic please contact Teresa Mercadal Menchaca at Bird & Bird by telephone (+34 91 790 6000), fax (+34 91 790 6011) or email (teresa.mercadal@twobirds.com). The Bird & Bird website can be accessed at www.twobirds.com.

Endnotes

(4) On October 17 2012 the European Commission approved a concept paper for public consultation on the implementing act on a common logo for legally operating online pharmacies/retailers offering medicinal products for human use for sale at a distance to the public (http://ec.europa.eu/health/files/falsified_medicines/commonlogo_consult.pdf). The responses to the consultation are available at http://ec.europa.eu/health/human-use/falsified_medicines/developments/2013-02_common_logo_pc_en.htm.