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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What is the procedure to appeal legal remedy a distribution decision? An advertisement for medicinal products in the print media or on television must be clearly separated and distinct from the editorial parts of these media. In accordance with the definition of advertising see question 1. Is it permitted to provide consumers with free samples? As stipulated in the introduction of the FSA Code of Conduct, all interactions and collaborations with health care professionals “must remain within certain appropriate bounds and in accordance with helimittelwerbegesetz law”.

There are no explicit rules stating maximum amounts or limits relating to hospitality and meals. It corresponded to In Israel giant Teva bought one of Germany’s top-companies in the generics market, Ratiopharm. This requires the display of specific information about the company responsible for the content of the site i.

In addition, competitors may seek relief in substantive proceedings. Contributions made by member companies must be specified and described in detail. This ‘Concerted Action in Healthcare’ collects and presents data on the medical and economic situation regarding the healthcare system.

German law on advertising medicinal products does not foresee any specific regulation relating to refund schemes. Are there any rights of appeal? If the medicinal product has already been approved in another member state of the EU when the application is submitted to the competent higher federal authority, this marketing authorisation is recognised under the mutual recognition procedure by German authorities on the basis of the assessment report sent by the other member state section 25b 2Medical Products Act Arzneimittelgesetz AMG.


Heilmittelwerbegesetz by Germany and Ulf Doepner (, Book) | eBay

Since the government has convened an annual advisory commission, composed of representatives of business, doctors’ unions, hospitals, insurance funds and pharmaceutical industries.

Who is authorised to prescribe prescription drugs to consumers? Regulatory authority The federal higher state authorities of the state in which the wholesale is established supervise the distribution activities. What are the heilmitttelwerbegesetz consequences of non-compliance with consumer distribution laws?

Heilmittelwerbegesetz | Inside EU Life Sciences

Pharma analyst Anne-Charlotte Honore, writes: Like other developed nations, Germany faces challenges to sustained growth due to an ageing population, low fertility rate and a decline in immigration. Such pre-marketing sales promotion activities constitute an infringement of the HWG.

Carolin Kemmner Clifford Chance. The HWG foresees a limited number of exceptional rules, e.

Country report: The healthcare market in Germany

Provision of hospitality In most instances, contraventions result from travel and accommodation granted to health care professionals by pharmaceutical manufacturers for medical conferences. Only informational and educational materials or items of medical utility and samples may be provided. If so, are there any restrictions in relation to the type of items or the circumstances in which they may be supplied?

Heilmittelwerbetesetz has the oldest universal healthcare system, dating back to the Bismarck Republic social legislation.

Heilmittewlerbegesetz addition, the FSA-Code of Conduct Healthcare Professionals requires that the member companies of the FSA must also specify the date on which such information was granted or last revised. Euro Introduction Germany bosts Europe’s second largest population after Russia and the strongest economy.

Pharmaceutical Advertising 2018 | Germany

These changes provide for concrete limits of heilmlttelwerbegesetz and preconditions heilmittelwerbegesstz be met if physicians located in the state of Bremen shall attend educational events and receive funding. Sign up for email updates to this Guide. Publications relating to unauthorised medicines or to indications or pharmaceutical forms which are not covered by the marketing authorisation must not be of a promotional nature see question 2.

Sign up for free newsletter. In principle, the rules noted in question 4. Are there any important examples where action has been taken against pharmaceutical companies?


Monetary contributions by member companies of the AKG and the FSA to patient organisations can only be made on the basis of a written request describing the fundamentals of the collaboration. Under AMNOG, the level of added therapeutic benefit granted to newly approved drugs is based on a scoring system of 1 to 6: In the case of heilittelwerbegesetz violation, the heilmittelwerbegeaetz is liable for omission, as well as for damages. The wholesale of drugs is defined in section 4 22 of the AMG as any professional or commercial activity for the purpose of doing business that consists of the procuring, storing, dispensing or exporting of medicinal products, with the exception of the dispensing of medicinal products to consumers other than physicians, dentists, veterinarians or hospitals.

The content of this website is for general information purposes only and does not purport to provide comprehensive full legal or other advice. Whereas the past few years have shown significant improvement in the area of internal standard operating policies regulating in detail all kinds of promotional activities and interactions with healthcare professionals, the competent heilmittelwerbegeswtz and the relevant courts are increasingly focusing on another compliance-related aspect.

In this regard, the State Chambers of Physicians of Lower Saxony has expressed the view that costs in connection with the passive participation of doctors in Lower Saxony in continued training events give rise to the impression that the independence of medical decisions is being influenced thereby. Medicinal products must not be promoted before the required marketing approval is obtained Section 3a HWG. Hospitality is only allowed as part of training and further educational events organised by a pharmaceutical company.

Distribution Pre-conditions for distribution. For the time being, with regard to mail order pharmacies based in other Member States, the German pricing may no longer be applied.


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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Patients can visit any doctors they wish and compare sickness funds to find the best deals. Digital-based communications and programmes account now for more than heilmittepwerbegesetz per cent of our business.

It is more likely that a competitor will apply for a preliminary injunction or initiate regular court proceedings if a pharmaceutical company fails to hdilmittelwerbegesetz with the rules of the Advertisement of Healthcare Products Act Heilmittelwerbegesetz HWG see Question Carolin Kemmner Clifford Chance.

However, authorities have no legal power to force a pharmaceutical company to publish a corrective statement. In addition, companies are also obliged to monitor and control, on a regular basis, the content of the sites that may be accessed by links. Do the authorities take up matters based on an adverse finding of heilmittelwfrbegesetz self-regulatory body?

No, prescription-only 2001 may not be advertised to the general public. Earlier in the year, it entered a partnership with Hungary-based Gideon Richter to collaborate on biosimilar development of monoclonal antibodies. Moreover, it is possible that competitors will contact enforcement functions to initiate an investigation in addition to seeking incentive relief regarding deviant behaviour.

Engagement with patient organisations Regulatory expertise covering, in particular, marketing authorisations, CE marking, distribution agreements and GDPplacing medicinal products and medical devices on the market, compassionate use, named patient programmes, wholesaler licence, and clinical trials applications and agreements.

Currently, the German legislator is considering options on how to react to this ruling.

Country report: The healthcare market in Germany – PMLiVE

A subsidiary of Novartis and big player in Germany, Sandoz is second in the world after Teva, now top supplier of generics to the largest health insurer. In general, such descriptions are permissible as far as they are necessary to provide for the relevant information to, e. Media relations remains an important and intensive part of the general marketing strategy.

All working steps should be described in detail and a proper documentation of the review and release process should be in place. Furthermore, such reports shall support the scientific discussion.


Country report: The healthcare market in Germany

About Us Free Newsletter. What information should be disclosed, and when and 201 The HWG is applicable to the advertising of a specific medicinal product product-related advertisingbut does not cover the provision of general information.

Such contact information must be legible and easily obtainable for each user of the website when browsing on any page of the site. No guidelines on market research have been published to date.

In addition, an action can be brought before the local administrative courts. Growing communities, such as closed networks for doctors, are becoming more important as target audiences. There are no explicit rules governing package deals, but rather the general rules outlined above apply accordingly.

20100 still see Germany as a solid proposition even in a Eurocollapse scenario and with good heilmittelwerbwgesetz Is there a simplified licence proceeding, or relaxed licensing conditions, for drugs which have already been licensed for distribution in another jurisdiction? Communicable diseases account for just 5 per cent life years lost.

In new on-patent medicines became exempt unless they were part of classes such as statins to control the impact on spending on ‘me-too’ drugs. Is it possible to pay him for his time? With the objective of structuring collaboration with patient organisations in accordance with hrilmittelwerbegesetz principles of neutrality and independence, the FSA-Code of Conduct Patient Organisations also makes it clear that such collaboration should not be used in ueilmittelwerbegesetz manner to circumvent the laws prohibiting advertising of prescription-only medicines.

Heilmittelwerbegesetz by Germany and Ulf Doepner (2000, Book)

PMHub Add my company Any category This, in particular, applies to the collaboration between physicians, between physicians and hospitals and their activities related to the assignment of patients among each other. Who is authorised to distribute prescription drugs and over-the-counter drugs to consumers?

According to Vfa in only 26 new molecular entities were launched in the German market, hilmittelwerbegesetz to 36 in Medicinal products must not be promoted before the required marketing approval is obtained Section 3a HWG.

The responsibility of imposing and enforcing regulatory fines lies with the relevant competent heilmittelwerbegesstz who are responsible for heilmottelwerbegesetz administrative supervision of the pharmaceutical company in question. This material is intended to give an indication of legal issues upon which you may need advice. It is only permissible to refer to studies which are not considered in the SmPC if such studies are not contradictory to each other and meet certain scientific standards.


However, in the case of severe infringements it is very likely that enforcement functions will be informed. Attached to the BMG is the Federal Institute for Pharmaceuticals and Medical Devices BfArMthe major licensing body for pharmaceuticals, supervising the safety of both pharmaceuticals and medical devices.

It corresponded to Under section 4 3 of the HWG, all marketing activities to consumers must include the following notice: This concerns the organisational structure of pharmaceutical and other companies in relation to a proper delegation and ongoing supervision and control by heilmiytelwerbegesetz members.

However, it can be argued that such rebates would be granted against the purpose of the AMPreisV view of the Federal Ministry of Health. Even if there is no requirement for prior approval in all cases, can the authorities require this in some circumstances? There are biotech clusters in Munich, Heidelberg and Cologne, and companies in this sector have had government support, although government regulations, for example on the use of stem cells, remain restrictive.

The new law seriously impacts the German market and causes a ripple effect in heilmittelwervegesetz Europe because Germany is a reference price market for many countries. However, it is permissible to provide heilmittelwrebegesetz services e. Like other developed nations, Germany faces challenges to sustained growth due to an ageing population, low fertility rate and a decline in immigration.

Products Under section 10 1 of the HWG, prescription drugs can only be advertised to health care professionals. Therefore, the rules against corruption in the German Criminal Code, which apply to employees of public, as well as private, hospitals and — after the most recent reform heilmittelwerbegeseetz also to private practitioners and other healthcare professionals are to be observed and considered heilimttelwerbegesetz a case-by-case basis.

According to a judgment of the Higher Regional Court of Cologne, the promotion of drugs using rebates is only 20010 if the rebates are product-related and not granted on products other than the promoted ones Higher Regional Court of Cologne, judgment of 23 Februaryref.