In recent years, Spanish authorities have intensified surveillance of websites offering unauthorized medications or counterfeit pharmaceutical products. Between 2012 and 2015, the AEMPS investigated more than 1,100 websites and promoted 340 cease and desist actions (official data; today the control continues). The message is clear: it is not a «minor issue» and can have criminal consequences.
If you are under investigation, it is important to know that trafficking in unlicensed medications can involve criminal liability, not just administrative. Here I explain how the regulations fit together, what risks you face and how to proceed.
What is the crime of trafficking in unlicensed medications and where is it regulated?
The trafficking in unlicensed medications and the illegal sale of pharmaceuticals are legally framed within the crimes against public health regulated in Chapter III of the Spanish Criminal Code. This legal block includes different criminal offenses that punish the distribution, commercialization or possession of unauthorized medications or counterfeit pharmaceutical products, when their use may endanger life or health.
Criminal conduct and Criminal Code articles applicable to trafficking in unlicensed medications
Manufacturing or commerce of harmful substances without authorization
Codified in article 359What are the penalties for drug trafficking without a license
The penalty for drug trafficking without a license depends on the type of conduct and the risk generated to public health. The Criminal Code establishes different levels of severity and sanctions that combine imprisonment, financial fines and professional disqualification.
Penalty for sale of medications without a license
The article 361 of the Criminal Code punishes with:
- Imprisonment of 6 months to 3 years
- Fine of 6 to 12 months
- Special disqualification of 6 months to 3 years from practicing profession or trade related
This penalty applies when manufacturing, commercializing, storing, importing or distributing medications without health authorization or health products that fail to meet technical requirements, provided there is risk to the health or life of persons.
Sale of counterfeit medications
When medications are counterfeited or altered, articles 362 and 362 bis of the Criminal Code apply, which increase the penalties:
- Imprisonment of 6 months to 4 years
- Fine of 6 to 18 months
- Special disqualification of 1 to 3 years
This includes cases of sale, distribution, intermediation or storage of counterfeit products, provided there is health risk.
Aggravating factors that increase the penalty
The article 362 quater CP elevates the penalty by one degree (for example, from 3 to 6 years imprisonment) if aggravating circumstances concur such as:
- Acting as a healthcare professionalWhat does the case law say about trafficking medicines without a license?
Selling is not enough: there must be health risk
A constant in the Supreme Court case law is that not all distribution of unauthorized medicines constitutes a crime. It is necessary that a concrete or potential risk to people’s life or health is generated. This makes the criminal offense one of concrete risk, not merely formal.
For example, if someone sells expired medicines online without medical supervision, but in insignificant quantities and without demonstrable adverse effects, criminal liability could be excluded due to lack of risk. However, if it involves altered drugs that induce errors in dosage or labeling, the crime is fully established.
Is an isolated sale a crime?
Although the Criminal Code also sanctions occasional conduct, sporadic sales between private parties of drugs that are not narcotics or controlled substances do not always fit under article 361 of the Criminal Code. In this regard, Criminal Court No. 5 of Getafe (Judgment 288/2014, of September 30) ruled out applying the criminal offense to a one-time sale of medicines between private parties, arguing that the typical verbs («manufacture», «commercialize», «store») refer to professional activities or those with certain continuity. Therefore, not every administrative violation automatically becomes a crime.
Practical example: anabolic steroids case
In a case tried by the Provincial Court, a person sold vials of anabolic steroids without
Do you need a criminal defense attorney in Madrid?
Abogado penalista en Madrid (Graduado en Derecho y ADE con Máster de Acceso a la Abogacía), experto en procedimientos complejos y técnicos en Derecho Penal. Cuenta con títulos como el Curso de DerechoPenal Avanzado impartido por magistrados del Tribunal Supremo en el Iltre. Colegio de Abogacía de Madrid.