Counterfeit Medicines and Anabolic Substances Lawyers

Pharmaceutical offences —the production of harmful substances, the marketing of unauthorised medicines that create a risk and the counterfeiting of medicines— are regulated in Title XVII of the Spanish Criminal Code, among the offences against collective safety, in Articles 359 to 362 quater. Under this common label sit very different forms of conduct: from the clandestine production of dangerous chemical products to the sophisticated counterfeiting of medicines sold over the internet, including the distribution of anabolic substances in the gym environment. As criminal defence lawyers we provide defence of the accused and prosecution in all of these offences, with over fifteen years of experience in the criminal jurisdiction.

Overview and Protected Legal Interest

The set of offences in Articles 359 to 362 quater shares a single legal interest: public health understood as a collective interest, that is, the safety of an indeterminate number of people against substances or products that may harm their life or integrity. What is protected here is not the health of a specific victim —for that there are the offences of bodily harm or homicide— but the health of the community as a whole. That is why they are placed among the offences against collective safety and not among the offences against persons.

A technical feature common to most of these offences is that they require the creation of a risk to the life or health of persons. A mere administrative irregularity is not enough: the conduct must create a real danger to public health. This distinction between the criminal wrong and the simple breach of health or pharmaceutical regulations is one of the main lines of defence, because much conduct is reprehensible at the administrative level without reaching the threshold of an offence.

Production of Harmful Substances (Arts. 359-360 CP)

Article 359 of the Criminal Code punishes whoever, without being duly authorised, produces substances harmful to health or chemical products liable to cause devastation, or dispatches, supplies or trades in them. The penalty is imprisonment of six months to three years and a fine of six to twelve months, and disqualification from the profession or industry for six months to two years. The core of the offence is the lack of authorisation: it punishes clandestine activity involving substances that by their very nature may harm health or cause devastation.

Article 360 addresses a different and less serious situation: that of whoever, being authorised to deal in those substances or products, dispatches or supplies them without complying with the formalities laid down in the relevant laws and regulations. In that case the penalty is a fine of six to twelve months and disqualification from the profession or trade for six months to two years, with no imprisonment. The difference between the two provisions is crucial: Article 359 punishes unauthorised activity, whereas Article 360 sanctions the breach of formalities by someone who does hold the relevant authorisation. Determining which of the two applies —or whether it is a mere administrative sanction— is the first step of the defence.

Unauthorised Medicines Creating a Risk (Art. 361 CP)

Article 361 is one of the central provisions on medicines. It punishes whoever manufactures, imports, exports, supplies, intermediates, markets, offers or places on the market, or stores for those purposes, medicines —for human and veterinary use, including investigational medicines— that lack the necessary authorisation required by law, or medical devices that do not have the conformity documents, or that are deteriorated, expired or fail to meet the technical requirements as to their composition, stability and efficacy, provided that this creates a risk to the life or health of persons.

The penalty is imprisonment of six months to three years, a fine of six to twelve months and disqualification from the profession or trade for six months to three years. The decisive element is again the creation of a risk: not every dispensing of a medicine without the requisite authorisation constitutes an offence, but only that which comes to endanger public health. This is precisely the ground on which the online sale of medicines without guarantees and the marketing of expired products or products with an altered composition are usually placed.

Counterfeiting of Medicines (Art. 362 CP)

Article 362 criminalises the counterfeiting of medicines in the strict sense. Its first paragraph punishes whoever produces a medicine —for human or veterinary use, or investigational—, an active substance or an excipient, or a medical device, in such a way as to present deceptively its identity (packaging, labelling, expiry date, name or composition of its components, dosage), its origin (manufacturer, country of manufacture, holder of the marketing authorisation) or its history (records and documents of the distribution channels), provided that they were intended for public consumption or use by third parties and create a risk to the life or health.

The second paragraph extends the same penalties to whoever alters —when manufacturing it or afterwards— the quantity, dose, expiry date or genuine composition of those medicines or products in a way that reduces their safety, efficacy or quality, creating a risk to health. The penalty is imprisonment of six months to four years, a fine of six to eighteen months and disqualification from the profession or trade for one to three years. This is the heart of the offence of counterfeit medicines: products that appear to be what they are not and which, by that deceptive appearance, endanger those who consume them.

Trafficking in Counterfeit Medicines (Art. 362 bis CP)

Article 362 bis complements the previous provision by punishing the conduct of distribution and marketing of medicines that have already been counterfeited. It applies to whoever, knowing of their counterfeiting or alteration, imports, exports, advertises or promotes, offers, exhibits, sells, provides, dispenses, dispatches, packages, supplies —including intermediation—, traffics, distributes or places on the market any of the medicines, active substances, excipients or medical devices referred to in Article 362, and thereby creates a risk to the life or health of persons. The same penalties apply to whoever acquires them for those purposes.

The penalty coincides with that of Article 362: imprisonment of six months to four years, a fine of six to eighteen months and disqualification for one to three years. The subjective element is key: the provision requires knowledge of the counterfeiting or alteration. Whoever distributes in good faith a product they are unaware is counterfeit does not commit this offence. Proof of that knowledge —or of its absence— is often the crux of the defence in cases of sales through internet platforms.

False Documents and Aggravated Types (Arts. 362 ter and 362 quater CP)

Article 362 ter punishes whoever produces any false or misleading document relating to the medicines, substances, excipients or medical devices of Article 362 —including their packaging, labelling and instructions for use— to commit or facilitate one of the offences of Article 362. The penalty is six months to two years' imprisonment, a fine of six to twelve months and disqualification for six months to two years. It is an instrumental offence aimed at suppressing the production of the documentation that gives an appearance of legitimacy to the counterfeit product.

Article 362 quater sets out the aggravated types, imposing the penalties one degree higher than those of Articles 361, 362, 362 bis or 362 ter where certain circumstances concur: that the offender is an authority, public official, physician, health professional, teacher, educator or physical or sports coach acting in the exercise of their office; that the products were offered through large-scale means of dissemination; or that they were offered or provided to minors or persons with a disability requiring special protection. The aggravation for large-scale dissemination is especially relevant to mass online sales, and the one concerning sports coaches connects this field with the world of gyms.

Anabolics in Gyms and Online Sales

Two scenarios concentrate much of the current casuistry of these offences. The first is that of anabolic steroids and other substances in the gym environment. Where those substances are produced or dispatched without authorisation they may fall within Article 359; where they are medicines —many anabolics are— marketed without the requisite authorisation and with a risk to health, the conduct may fall within Article 361; and where the product is counterfeit or its composition has been altered, Articles 362 and 362 bis come into play. The characterisation depends, in each case, on the nature of the substance, its origin and the risk actually created.

The second scenario is the online sale of counterfeit medicines: weight-loss pills, erectile dysfunction products, hormones or anabolics offered through websites and social media. Here Article 361 (unauthorised medicines), Article 362 (counterfeiting) and Article 362 bis (distribution with knowledge of the counterfeiting) usually concur, and frequently the aggravated type of Article 362 quater for large-scale dissemination. The defence examines the traceability of the product, the existence of a real risk established by an expert report and the knowledge the accused had of the counterfeiting.

Difference from Sports Doping (Art. 362 quinquies CP)

These offences must be distinguished from sports doping under Article 362 quinquies, which has its own page at this firm. Article 362 quinquies punishes those who, without therapeutic justification, prescribe, provide, dispense, supply, administer, offer or facilitate to athletes prohibited substances or pharmacological groups, or non-regulatory methods, intended to enhance their physical capacities or to alter the results of competitions, where by their content, repeated intake or other circumstances they endanger the life or health of the athlete. The penalty is imprisonment of six months to two years, a fine of six to eighteen months and disqualification for two to five years.

The essential difference is that Article 362 quinquies does not require the medicine to be counterfeit or to lack authorisation: it punishes the supply of doping substances to athletes with a danger to their health, even if the substance itself is lawful in another context. It is an offence centred on the sporting sphere, with identifiable victims —the athletes— and specific aggravations (minor, deception or intimidation, relationship of superiority). The in-depth analysis of that offence is dealt with on the sports doping page.

Difference from Drug Trafficking (Art. 368 CP)

It is also essential to distinguish these offences from drug trafficking under Article 368. The latter punishes those who carry out acts of cultivation, production or trafficking, or otherwise promote, favour or facilitate the illegal consumption of toxic drugs, narcotics or psychotropic substances, or possess them for those purposes. The material object is different: Article 368 concerns illegal narcotics and psychotropics, whereas Articles 359 to 362 quater revolve around medicines, medical devices and harmful substances.

The distinction is not merely academic. The same substance may fall under one regime or the other according to its nature and regulation, and the penalties differ markedly. Drug trafficking under Article 368 has its own basic type and its own aggravated types. Correctly characterising the facts —pharmaceutical offence versus drug trafficking— is decisive for the procedural strategy and for the penalty ultimately applicable.

Defence Strategies

The defence in these matters starts from a rigorous technical analysis. The first line consists of disputing the creation of a risk to life or health: without that real danger, normally established by an expert report, the conduct is reduced to the administrative sphere and does not reach criminal reproach. The second examines the subjective element: Article 362 bis requires knowledge of the counterfeiting, so that the distributor's good faith excludes the offence. The third assesses the correct characterisation of the facts, distinguishing Article 359 from 360, or the pharmaceutical offence from sports doping or from drug trafficking.

Alongside this, the chain of custody of the seized substances, the validity of the analyses carried out on the product's composition and the lawfulness of the searches are scrutinised. From the prosecution, by contrast, we build the evidence of the risk created, of the knowledge of the counterfeiting and of the large-scale dissemination or the offering to minors that ground the aggravated types of Article 362 quater, with the aim of effectively protecting public health.

Limitation Period

As regards the limitation period, under Article 131 of the Criminal Code the period is determined by the maximum penalty attached to the offence. The offences whose custodial penalty does not exceed three years —Articles 359, 361 or 362 ter— become time-barred after five years. The types with a custodial penalty of up to four years, such as Articles 362 and 362 bis, become time-barred after ten years, since they exceed the five-year maximum-penalty threshold. In the aggravated types of Article 362 quater, raising the penalty by one degree may alter the applicable period, a point the defence verifies case by case.

Time runs from the completion of the offence or, in continuing conduct —such as marketing sustained over time—, from the cessation of the criminal activity. Verifying that the full period has elapsed is an essential check, because limitation extinguishes criminal liability and is one of the grounds for dismissal and acquittal that the defence must examine from the very outset of the proceedings.