Pharmaceutical Crimes in Spain: Unauthorised Medicines, Counterfeits and Anabolic Steroids (Arts. 361 to 362 quinquies CP)

Selling anabolic steroids in a gym or online, dispensing medicines without prescription or licence, and trafficking in counterfeit drugs are not mere administrative infringements in Spain: articles 361 to 362 quinquies CP, within the offenses against public health, punish these acts with up to four years in prison, rising one degree when the offender is a health professional, teacher or coach. As criminal defense lawyers specialised in counterfeit medicines and doping substances, with +15 years of experience, we explain what each provision punishes, who can be held liable and how the defense is built.

What articles 361 to 362 quinquies CP punish

These pharmaceutical offenses share one structure: conduct involving medicines for human or veterinary use and medical devices which must create a risk to the life or health of persons. They are offenses of endangerment: no one needs to be injured, but without that risk there is no crime.

Article	Conduct	Prison
361	Unauthorised, deteriorated or expired medicines	6 months to 3 years
362	Manufacturing or altering counterfeit medicines or medical devices	6 months to 4 years
362 bis	Knowingly trafficking or distributing counterfeits	6 months to 4 years
362 ter	False documents relating to these products	6 months to 2 years
362 quater	Specific aggravating circumstances	Penalty one degree higher
362 quinquies	Sports doping	6 months to 2 years

Full text available in the Criminal Code as published in the Official State Gazette (BOE).

Article 361 CP: unauthorised, deteriorated or expired medicines

Article 361 CP punishes anyone who manufactures, imports, exports, supplies, brokers, markets, offers or places on the market —or stores for those purposes— any of the following:

• Medicines for human or veterinary use, including investigational medicines, which lack the authorisation required by law.
• Medical devices lacking the required conformity documents.
• Products which are deteriorated or expired, or which fail to meet the technical requirements on composition, stability and efficacy.

The conduct is only criminal if it creates a risk to the life or health of persons. The penalty: six months to three years in prison, a fine of six to twelve months and special disqualification from the profession or trade for six months to three years.

This is the provision usually applied to the sale of anabolic steroids outside the legal channel: they are prescription medicines, and marketing them outside the health authorisation system falls within the offense whenever there is danger to health.

Counterfeit medicines: articles 362, 362 bis and 362 ter CP

Article 362 CP imposes six months to four years in prison, a fine of six to eighteen months and special disqualification for one to three years on anyone who manufactures or produces a medicine —including active substances and excipients— or a medical device in a way that deceptively presents:

• Its identity: packaging, labelling, expiry date, composition or dosage.
• Its origin: manufacturer, country of origin or holder of the marketing authorisation.
• Data on legal compliance, licences or authorisations, or its distribution history.

Its second paragraph applies the same penalties to anyone who alters the quantity, dose, expiry date or genuine composition, reducing their safety, efficacy or quality. In both cases the products must be intended for public consumption or use by third parties and a risk to life or health must be created.

Article 362 bis CP extends those penalties to the marketing stage: importing, advertising, offering, selling, supplying, trafficking or distributing counterfeit products with knowledge of their falsification or alteration. Its second paragraph punishes equally anyone who acquires or stocks them in order to destine them to public consumption or use by third parties.

The block closes with article 362 ter CP: producing false or misleading documents relating to these products to commit or facilitate the offenses of article 362 carries six months to two years in prison, a fine of six to twelve months and disqualification for six months to two years.

Aggravating circumstances of article 362 quater CP: penalty one degree higher

Article 362 quater CP imposes the penalties one degree higher than those of articles 361, 362, 362 bis and 362 ter when any of these circumstances applies:

• The offender is an authority, public official, physician, health professional, teacher, educator or physical or sports coach, acting in the exercise of their office, profession or trade.
• The products were offered through large-scale media, or were offered or supplied to minors, persons with disabilities in need of special protection or especially vulnerable persons.
• The offender belongs to a criminal organisation or group devoted to these offenses.
• The acts were carried out in establishments open to the public by their managers or employees.

These circumstances are decisive: a sale by a gym coach can trigger two of them at once —coach status and establishment open to the public— and offering the products on open websites may qualify as large-scale dissemination.

Article 362 quinquies CP: the sports doping offense

Article 362 quinquies CP punishes those who, without therapeutic justification, prescribe, supply, administer, offer or facilitate to athletes —federated or not, even recreational— prohibited substances or pharmacological groups, or non-regulation methods, intended to increase their physical capacity or to alter the results of competitions, when, by their content or repeated intake, they endanger the life or health of the athlete.

The penalty: six months to two years in prison, a fine of six to eighteen months and special disqualification from public office, profession or trade for two to five years. It is imposed in its upper half if the victim is a minor, if deceit or intimidation was used, or if the offender took advantage of a relationship of labour or professional superiority. The offense targets the supplying circle —doctors, trainers, coaches—, not the athlete who dopes. We analyse it in our guide to the sports doping offense and in our overview of sports criminal law in Spain.

Anabolic steroids: who can be held liable and the difference with drug trafficking

Investigations usually target several profiles at once:

• The private individual who resells cycles bought online: article 361 CP, or article 362 bis if they are also counterfeit.
• The coach or personal trainer who supplies substances: articles 361 or 362 bis with the aggravation of article 362 quater and, if the recipient is an athlete, article 362 quinquies.
• The gym owner or employees who take part in sales: aggravation for establishments open to the public.
• Pharmacists and health professionals who dispense without prescription or divert medicines: the aggravation of article 362 quater plus professional disqualification.

These offenses should not be confused with drug trafficking under article 368 CP, which punishes the cultivation, production and trafficking of toxic drugs, narcotics and psychotropic substances with one to six years in prison depending on the substance. Anabolic steroids are not listed as narcotics, so their illegal sale is prosecuted under articles 361 et seq. We explain that regime in our guide to article 368 CP on drug trafficking.

Defense strategies in pharmaceutical crime cases

• Absence of risk to health. All these offenses require a real risk to life or health. Expert evidence on the composition, dose and condition of the seized substances is central: if the product was genuine and no capacity to harm is proven, an element of the offense is missing.
• Personal use. Acquiring the products for personal consumption is not criminalised: article 362 bis requires the purpose of destining them to public consumption or use by third parties. Small quantities, no sale paraphernalia and user status support this line.
• No knowledge of the falsification. Article 362 bis requires knowledge of the falsification or alteration; a mistake about the authenticity of the product excludes intent.
• Therapeutic justification and the notion of medicine. In doping cases, a legitimate medical prescription excludes the offense. And under article 361 it can be argued that the substance is not a medicine subject to authorisation but a food supplement, governed by administrative rules.

If you are under investigation in Spain for selling medicines or anabolic steroids, act from the outset: the legal classification of the facts and the expert analysis of the substances make the difference between acquittal, a fine and prison. Call us on +34 910 786 574 to discuss your case with a criminal defense lawyer.