The Ministry of Health and Care has recently issued a hearing letter proposing stringent restrictions on import of medicinal products for personal use. Among the actions proposed, is a general ban on the import of prescription drugs, and access for Customs to seize and destroy falsified or illegal medicinal products.
Currently Norway permits import of medicinal products for personal use from EU or EFTA member states via mail, internet etc. The limitations are that the medicines are for personal use, that amount does not exceed three months of use during a three month period, and that the drugs have been legally obtained in the country of origin. For prescription drugs, this includes that they have been prescribed by a physician, cg. the Regulation on manufacturing and import of medicinal products Section 3-2.
Import from non EEA-countries is not permitted without permission from the Norwegian Medicines Agency (NMA), unless the medicines are imported upon the person's entry into Norway (in such cases, a limitation for 3 months use applies). For drugs that are classified as either narcotic substances or performance enhancing drugs, special rules applies.
The import of medicinal products for personal use via internet sales has risen in Norway during the later years, and a major portion of the import falls into the categories of either falsified drugs or illegal drugs. Falsified medicines are medicines with an incorrect description or origin, presented as a drug placed legally on the market. Such drugs often contain too much or too little (if any) of the active substance.
A survey done by the NMA illustrates that 62% of medicinal products from internet sale are falsified.
Illegal drugs are drugs placed on the market without prior approval from the authorities, often containing analogs to approved active substances. This also includes products that appear as nutrition supplements, but contains active substances classified as medicinal products - overrepresented in this category is weight reducing products, painkillers, hair-loss treatments and products for treatment of impotence.
A major problem in Norway is the restrictions on the right to seize and destroy falsified or illegal drugs. For other cases than narcotics, shipments containing falsified or illegal drugs intended for personal use have, to a large extent, been returned to the sender.
Acknowledging that falsified and illegal drugs represent a serious threat to the public health, the Ministry finally presented its proposed actions in a hearing letter published on 4th September 2012.
In the hearing letter, the Ministry states that not only falsified and illegal drugs represents a threat to the public health, but also underlines other challenges with personal import. Lack of counsel by health care personnel with regards to the use and effect of the drugs, that the use of prescripted drugs may be unknown for the treating physicians, the risk of serious adverse effects not being reported and the lack of a Norwegian package leaflet instructing the patient about the proper use are highlighted.
On this background, the Ministry proposed several changes to the current legal situation regarding import for personal use ordered via mail, internet etc.:
- A general ban on import of prescription medicinal products.
- A general ban on import of medicinal products that do not have marketing authorisation in Norway.
- The right for Customs to seize and destroy shipments of
medicinal products imported in violation with the Medicines Act,
without prior report to the police. When a shipment is seized, the
recipient will be notified, and given a response time of 10 days.
- If the recipient does not respond, the NMA will issue a decision to destroy the medicinal products.
- Should the recipient respond, the NMA will have to evaluate the case, and decide whether or not the shipment shall be destroyed.
- The decision of the NMA may not be appealed to the Ministry.
It is important to emphasise that the proposed ban only concerns import of medicinal products for personal use ordered via mail, internet etc. The actions proposed by the Ministry therefore do not concern medicinal products that are imported upon a person's entry into the country.
The general ban on import via mail, internet etc. does not concern non-prescription drugs. However, the hearing letter states that it is the prescription status in Norway that will be decisive. This means that import of an OTC-product from e.g. Germany will be considered to be in violation of the proposed rules if the same medicinal product is a prescription drug in Norway.
According to Article 11 of the EEA-agreement (equivalent to TFEU Art. 34), quantitative restrictions on imports and all measures having equivalent effect shall be prohibited.
However, in accordance with Article 13, (equiv. TFEU Art.36) prohibitions based upon the protection of public health may be justified, provided they are deemed as both necessary and proportionate. In this regard, the hearing letter mentions a decision from the European Court of Justice, C- 322/01, in which the Court decided that Article 30 EC (now TFEU Art. 36) "may be relied on to justify a national prohibition on the sale by mail order of medicinal products which may be sold only in pharmacies in the Member State concerned in so far as the prohibition covers medicinal products subject to prescription."
Furthermore, the hearing letter also mentions that Article 85c in Directive 2011/62 assumes that the member states may prohibit the sale of prescription drugs via mail, internet etc. thus indicating that the proposed prohibition will be justified by reasons of public health.
The time limit for comments for the proposal is 4th December 2012.
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Inga Kaasen is an attorney-at-law and partner at the Norwegian law firm Grette. She also holds a PhD. in biotechnology. She is the leader of Grette's Life Sciences team, and has extensive experience with patent disputes, pharmaceutical law, IP transactions and R&D agreements.
Håkon Austdal is an associate at the Norwegian law firm Grette. He also holds a Bachelor of Pharmacy. He is a member of Grette's Life Sciences team, working with patent disputes and pharmaceutical law.
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