Field of Healthcare (Heilmittelwerbegesetz – HWG), last amended on 20 System and their Employees were published in December reading of the proposal in November In the second part of .. Germany, the Remedies Advertising Act (Heilmittelwerbegesetz – HWG) were in line with the. Health on the Net Foundation. (accessed 9 June ). I S. ) vom 26 April Heilmittelwerbegesetz. [18] ICMJE.

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However, in practice, infringements of the regulations of the HWG are only prosecuted in exceptional cases. No, there are no specific rules, laws or guidance, controlling the use heilmitttelwerbegesetz social media by companies. Therefore, the pure funding of a nurse or the costs of a laboratory nurse by a company might heilmittelwebregesetz become critical with respect to a medical institution, provided that this is not part of a proper contractual relationship.

In addition, an action can be brought before the local administrative courts. The German legislator has different options to react to this judgment: The question of whether or not the provision of gifts or other benefits is permissible therefore depends on the circumstances of the individual case taking into consideration the different regulations and rules. It is, however, acknowledged that a pharmaceutical company may reimburse conference fees, and reasonable travel heilmitfelwerbegesetz accommodation costs.

Extensive experience in advising companies on all matters concerning pricing and reimbursement in the out- and in-patient sector that is, AMNOG, NUB, rebates, reference pricing, DRGs and pre-market access strategies. Consequently, the risk of infringement of the HWG is higher the more such scientific information relates to a specific product or product trademark, or is used in relation heilmittelwerbegesehz the advertising activities for an unauthorised product.

Distribution and marketing of drugs in Germany: overview | Practical Law

Another challenge is to tailor communications to each relevant healthcare professional target group, as there is a huge diversity of specialities and conditions, with an array of professional bodies and associations. Section 4 17 of the AMG defines placing on the market as keeping the product in stock for sale or for other forms of supply, the exhibition and offering for sale and the distribution to others.

Consequently, such campaigns would not be subject to the strict regulations of the HWG but, nevertheless, would need to be in compliance with the general rules of the UWG, i. The reference medicinal product must have heilmittepwerbegesetz been authorised for at least eight years before such an application will be considered. With the exception of the name and address of the pharmaceutical entrepreneur or the sponsor, as well as the name and the address of the consenting investigators, the report may not contain personal or especially patient-related data.


Therefore, the potential involvement of hospital physicians in the solicitation of the donation has to be disclosed to and approved by the hospital administration. However, it can be argued that such rebates would be granted against the purpose of the AMPreisV view of the Federal Ministry of Hfilmittelwerbegesetz.

The HWG is applicable to the advertising of a specific medicinal product product-related advertisingbut does not cover heikmittelwerbegesetz provision of general information. All other intentional or negligent breaches of explicitly listed regulations of the HWG may result in fines of up to EUR 50, In the new regulatory landscape, communications have to start much earlier, in the pre-launch phase, with communicators thinking laterally and treading carefully. The HWG foresees a limited number of exceptional rules, e.

Only section 1 6 of the Advertisement of Healthcare Products Act Heilmittelwerbegesetz HWG states that the HWG does not apply to order forms of online pharmacies regarding the information necessary for ordering of drugs online.

However, press releases are most likely to be considered promotional and therefore, unlawful where the anticipated new product name is mentioned. General — Medicinal Products. The same applies to indications or pharmaceutical forms which are not covered by the marketing authorisation off-label information. According to established case law in Germany, a gift is considered as “inexpensive” if it does not exceed the value of EUR1 to EUR2 purchase price. The maximum fee is EUR57, In addition, a pharmaceutical manufacturer must respect the neutrality and independence of a patient organisation, in particular regarding the events organised by the patient organisation the principle of neutrality.

If so, what conditions apply?

Pharmaceutical Advertising | Germany | ICLG

Prior to the federal elections in Autumn a decision has not been taken by the previous legislator. The Medical Association of Lower Saxony interprets this provision in a very strict way. However, in anticipation of the legal developments, many companies have already heilmlttelwerbegesetz self-employed physicians in the same way as privately or publicly employed clinic physicians. I understand more info.

Germany bosts Europe’s second largest population after Russia and the strongest economy. Likewise, if the benefit granted to the physicians by providing the associated benefits is able to induce the prescription of the medicine, the package deal is heilmittelwerbegdsetz subject to the new Sections a and b German Criminal Code. Prices are negotiated with the federation of health insurers and not individual funds.


The Health Insurance Funds are mandated heilmitteowerbegesetz provide a wide range of coverage and, sincepatients can choose which fund to join and move between funds. This applies, for example, to the provision of so-called patient support programmes which aim to support patients with the administration of a prescribed pharmaceutical that follow a complex therapy regime.

The purpose was to reduce expenditure for dental care, physiotherapy and transportation, to make the patient liable for pharmaceutical costs above reference prices and to reward ‘responsible behaviour’ and good preventive practice with lower co-payments.

In this respect, heillmittelwerbegesetz principles of separation, transparency, documentation equivalence as stipulated in the Common Position Concerning the Consideration of Cooperation between Industry, Medical Institutions and Staff under of Criminal Law outline valuable reference points for the collaboration of the pharmaceutical industry with health care professionals from the outpatient sector or those working in hospitals.

Apart from the legal provisions relating to the healthcare sector, German websites have to comply with the relevant regulations of the German Telecommunication Services Act Teledienstegesetz. Engagement with patient organisations is regulated in the relevant industry codes. Name the specific sites for which the authorisation is to be issued. Growing heilmittelwerbegedetz, such as closed networks for doctors, are becoming more important as target audiences.

It can file an objection to the decision since such decisions by competent authorities are considered to be administrative acts. Moreover, it is possible that competitors will contact enforcement functions to initiate an investigation in addition to seeking incentive relief regarding deviant behaviour.

Distribution and marketing of drugs in Germany: overview

Furthermore, such reports shall support the scientific discussion. Exceeding the rate by more than 2. Many cases before the FSA 20010 of Arbitration result from gifts or services offered by pharmaceutical companies to health care professionals. Communications materials must be drafted within these tight legal limits, where the product cannot be named if patients or public audiences are addressed directly.