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Compliance and enforcement

Enforcement

What measures are in place to enforce the laws governing medicinal products?

The Medical Products Agency has enforcement powers – for example, it can conduct inspections, order corrections, withdraw licences and report certain actions as criminal offences, as well as naming and shaming in relation to non-compliance reports in EudraGMPD.

Dishonest practices

What mechanisms are in place to combat bribery, fraud, collusion, counterfeiting and other dishonest practices in the pharmaceutical sector?

The Swedish anti-bribery legislation is the main mechanism in place to combat bribery, fraud and other dishonest practices. The Swedish Prosecution Authority has a national unit, the National Anti-corruption Unit, which investigates corruption crimes. The unit also promotes uniformity in legal proceedings by working on judicial matters within the area. The ethical rules (see above) complement the Swedish anti-bribery legislation, which also provides the pharmaceutical sector with guidelines on, for example, interactions with representatives of the public and healthcare sectors.

The Swedish Association of the Pharmaceutical Industry is a member of the European Federation of Pharmaceutical Industries and Associations (EFPIA), and is part of the EFPIA initiative on disclosure of transfers of value from pharmaceutical companies to healthcare professionals and healthcare organisations.

In addition, the Swedish Anti-corruption Institute – a self-regulatory business body – has issued a general and non-binding Code of Business Conduct for best practice in matters relating to fraud and corruption.

Based on registered IP rights, holders can request customs action against suspected counterfeit goods in Sweden or in designated EU member states (depending on the territory covered by the registered rights). In order to prevent manipulation of the packaging of prescription drugs, an identification number and certain security details will become mandatory. Websites of legally operating online pharmacies/retailers must use a common logo that is recognisable throughout the European Union (Directive 2011/62/EU).

Sweden has competition laws which prevent unlawful collusion between competitors.

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