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The sale of medicines via the internet in Spain

  • United Kingdom
  • Spain
  • Health and life sciences

09-12-2016

In Spain, the sale of medicines via the internet is dealt with by Law no. 34/2002 on Information Society Services and E-commerce, which transposed the Directive 2000/31/EC and which envisaged the use of internet to commercialise medicines and medical devices, although this law referred to potential “specific legislation” on those topics.

More recently, Law 29/2006 was enacted in relation to the guarantees and rational use of medicines and healthcare products. The Law is limited to non-prescription drugs, although it provides that “the implementing regulation shall specify the exact requirements needed for selling non-prescription medicines”. E-commerce of prescription medicines was expressly forbidden.

Thus, for many years the pharmaceutical wholesalers have seen how the Law of 2006 allowed them to sell non-prescription medicines via the internet in theory, but in the absence of an implementing regulation, selling medicines online was not in fact possible in practice.

The situation changed with the entry into force of the Royal Decree 870/2013, which aimed to regulate distance selling to the general public, via websites, of non-prescription medicines for human use. The principal aim of which was to grant legal certainty for the sale of medicines via the internet, as well as to prevent the acquisition of counterfeit medicines. The Royal Decree excludes from its scope other healthcare products as personal care products, cosmetics or infant food preparations.

In respect of the requirements for dispensing medicines via the internet, the Royal Decree provides that:

i) Only duly authorized pharmacies open to the public are entitled to carry out this type of sale;

ii) All sales have to be made by a qualified chemist with personalised advice and from an open pharmacy (this is to say, that only the dispensing chemists are able to sell medicines via the internet);

iii) The pharmacies which intend to sell medicines online have to have communicated that decision in advance to the competent authority;

iv) Pharmacy websites have to meet the specific legal requirements; and

v) The medicines offered to the public must provide the legally requested information.

Finally, in order to ensure that the final consumer can ensure they are purchasing from a trusted website and avoid counterfeit medicine, it is mandatory that any legal website in Spain shows the official EU logo for the lawful online sale of medicines, as designed and imposed by Regulation (EU) 699/2014.

Other legal obligations

The Royal Decree does not allow the final consumer to order any medicine anonymously because the pharmacist is obliged to make contact with the consumers before shipment and advise them on the proper use of the medicine. However, the pharmacist’s obligation may be replaced by a link to a website containing information related to the ordered medicines.

In respect of the return of purchased medicines, the general rule is that returning the delivered medicines is not possible. As an exception, the pharmacist shall be obliged to accept the return of medicines and to destroy them if the medicines are incorrectly supplied, the medicines delivered do not correspond to what was ordered or if the medicines have been damaged during transport. Additionally, the consumer shall be entitled to a full reimbursement when the delivery time exceeds over 50% of the time specified for the purchase.

Finally, pharmacists should create extensive records of all shipments, maintaining these records for at least two years.

Conclusion

In conclusion, selling prescription medicines via the internet remains expressly prohibited in Spain. It is expected that this scenario will not change, as dispensing prescription medicines requires tight regulation in order to control the flow of medicines, ensure the correct and appropriate use of them and to allow for the protection of the patient and a legal certainty.

As for the sale of non-prescription medicines, even if for some time there was "some legal uncertainty" because the implementing regulation required had not been developed, the current situation has changed and Spanish Law now allows the sale of non-prescription medicines under strict regulations, which guarantees that proper advice is given to consumers by healthcare professionals.

Finally, despite a background of extensive EU regulation regarding medicine for human use, harmonization between EU member states on this issue is incomplete and many differences still exist between member states. In light of the above, it would be desirable to develop greater harmonisation, particularly in respect of sales to the final consumer and including those purchased online.

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