Professional relationships and financial support, applicable to healthcare professionals and specialists

A professional relationship is, for example, when a healthcare professional performs a task for or in collaboration with a company, even if the healthcare professional does not personally receive payment. 

If a company sponsors an activity, and part of the sponsorship is spent on personal remuneration to a healthcare professional, this is also defined as a professional relationship.

Read more about the healthcare professionals that are covered by the rules on professional relationships here.

Types of professional relationships requiring prior permission from the Danish Medicines Agency.

Regarding applications for permission, the processing time is one to two weeks.

1. Professional information includes the writing of articles, participation in podcasts, preparation of leaflets and other material
2. Advisory board includes participation in groups of experts, steering committees and roundtable meetings
3. Adviser is an advisory function and also consultancy tasks
4. Chairperson of meetings involves the planning of conferences and other meetings which you help plan
5. Panellist in debates not open to the public
6. Member of boards of directors/fiduciary position
7. Shares/securities of more than DKK 200,000 at the time of acquisition

The list is not exhaustive, and in case of doubt as to which category fits your tasks, select 'Øvrigt' ('Other'). 

Types of professional relationships requiring prior notification to the Danish Medicines Agency.

1. Notification must be given of professional information if such contribution is made for the purpose of press coverage or survey participation. Other types of professional information require prior permission. See 'Types of professional relationships requiring prior permission' above.
2. Research includes participation in clinical trials, tests and investigations of medical devices as well as non-intervention trials. 
   
   Notification must be given of your research if:
   
   - you are a primary investigator or have similar responsibilities
   
   - you are a sub-investigator and personally remunerated by the company.
3. Educational activities
4. Presentations
5. Panellist in debates open to the public
6. Ownership/shares of up to DKK 200,000 at the time of purchase in a pharmaceutical or medical device company There is no lower notification threshold.

Generally, the Danish Medicines Agency does not assess your notification of a relationship.

We publish the information you submit and use the exact wording of your notification.

Read here about the rules applying to doctors, nurses, dentists, proprietary pharmacists and prescribing pharmacists participating in panel debates involving the industry. The rules are relevant to healthcare professionals participating in panel debates at the democratic festival on Bornholm this summer. 

If you are a healthcare professional and participate in a public panel debate arranged by a pharmaceutical or medical device company, or if you receive payments from a company for your participation in a debate, you must notify the Danish Medicines Agency of your professional relationship before you participate in the debate.

Doctors, dentists and nurses undertaking clinical duties in Denmark as well as proprietary pharmacists are covered by the notification duty if they have professional relationships with pharmaceutical and medical device companies as well as companies manufacturing, importing or distributing products without an intended medical purpose. Midwives and prescribing pharmacists are only covered when having professional relationships with pharmaceutical companies.

Panel debates open to the public

Participation in panel debates open to the public and arranged by pharmaceutical companies, medical device companies or companies manufacturing, importing or distributing products without an intended medical purpose or stores specialised in the sale of medical devices (by doctors) about general health issues only requires prior notification to the Danish Medicines Agency. This also applies if the company co-arranges a panel debate – for example with the media, a patient association or other organisation or if the company has asked an agency or a consultancy firm to arrange the panel debate. 

You also have to notify the Danish Medicines Agency of your professional relationship if the panel debate is arranged by the media, a patient association or other organisation or via an agency/consultancy firm, and the event is supported financially by a pharmaceutical company, a medical device company or a company manufacturing, importing or distributing products without an intended medical purpose or a store specialised in the sale of medical devices (by doctors), and you as a healthcare professional receive payments from this company.

You can use the form in the blue box above, to notify us about a professional relationship. In the form, select the relationship type 'Paneldebat med offentlig adgang' ('Panel debate open to the public').

Participation in panel debates not open to the public requires prior permission

Participation in panel debates not open to the public requires prior permission from the Danish Medicines Agency. 

You may use the above form to apply for our permission to establish a relationship. Select the relationship type 'Paneldebat uden offentlig adgang' ('Panel debate not open to the public'), and describe your relationship.

Do you need to take any further action?

If you participate in a debate financially supported but not arranged or co-arranged by a pharmaceutical company, medical device company or company manufacturing, importing or distributing products without an intended medical purpose or a store specialised in the sale of medical devices (by doctors), you do not have to notify us of your relationship with the company, unless you are remunerated for your participation, and the remuneration is taken from the support provided by the company.

The company must inform you of your obligations

When contractually agreeing to establish a professional relationship with a doctor, nurse, dentist, proprietary pharmacist or prescribing pharmacists and midwives (only pharmaceutical companies), pharmaceutical companies, medical device companies or companies manufacturing, importing or distributing products without an intended medical purpose or a store specialised in the sale of medical devices (by doctors) must inform healthcare professionals of their obligations to the Danish Medicines Agency. Companies must inform healthcare professionals of their notification and application duties and of the Danish Medicines Agency's publication of information on the professional relationship on a

Our lists of companies having professional relationships with healthcare professionals will show whether a company is covered by the rules or not.  If appearing on one or more of the four lists of companies, a company must inform you of the rules. 

The examples below are all based on the assumption that you are a healthcare professional within one of the professions midwife, doctor, nurse or dentist and that you either treat patients, have a managerial position influencing the choices made by others in relation to patient treatment, are a prescribing pharmacist and work in a prescription-handling unit or are a proprietary pharmacist.

• I'm giving a presentation or attending a meeting, but I'm not being paid for it by the company; should I notify the Agency of this?

Yes, if you perform a task for a company, you must always notify us of it or apply for permission to perform such task, even if you won't be paid for it. 

• I have a company or am employed in a company through which I have been hired by a pharmaceutical or medical device company to act as their consultant; should I notify the Agency of this?

Yes, even if it is the company you own or are employed by that is hired for the task, and the payment is made to the company, you as a healthcare professional will be the one having a professional relationship with the company, and you must therefore notify us of or apply for permission for the relationship.

• When is a task carried out in connection with a meeting or event arranged through a third party a professional relationship and when is it not?

What is a third party?
It could be your workplace, a communications or PR agency, a professional society and many others.

If a pharmaceutical or medical device company financially supports a meeting or event and co-arranges the meeting or event, this is defined as a relationship whether you are personally remunerated or not. 

If a pharmaceutical or medical device company financially supports a meeting or event, but does not co-arrange the meeting or event, and you are personally remunerated through payment from the company, this is defined as a relationship.

If a pharmaceutical or medical device company financially supports a meeting or event, but does not co-arrange the meeting or event, and you are not personally remunerated, this is not defined as a relationship.

Example: My workplace has been granted a sponsorship for an after-work meeting in my department. I am to give a presentation, but I won't be personally remunerated through the sponsorship – the money is solely spent on the renting of premises and food. Should I notify the Agency of this as a relationship? – No, when the company only sponsors and does not co-arrange the event, you do not have to notify us as long as you are not personally remunerated through the sponsorship.

When healthcare professionals hold shares in a pharmaceutical or medical device company, they must:

- Notify the Danish Medicines Agency if the amount at the time of acquisition is below DKK 200,000 – there is no triviality threshold. Submit an application to the Danish Medicines Agency if, at the time of acquisition, the amount exceeds DKK 200,000 – there is no triviality threshold.

• I have shares worth less than DKK 200,000 in a pharmaceutical or medical device company; should I notify the Agency of this?

Yes, no triviality threshold exists for when to notify us of your shares, and the Danish Medicines Agency must be notified of all amounts below DKK 200,000.

• I have shares in an investment fund, pension fund or pool with investment decisions delegated to a third party; should I notify the Agency of this?

No, when investment decisions are delegated to a third party, you do not have to notify the Danish Medicines Agency of it or apply for permission for it.

• I have ETF shares; should I notify the Agency of this or apply for permission for them?

No, when investment decisions are delegated to a third party, you do not have to notify the Danish Medicines Agency of ETF shares or apply for permission for them.

• My cohabitant, spouse or children have shares in a pharmaceutical or medical device company; should I notify the Agency of this or apply for permission for it?

No, you only have to notify us of or apply for permission for shares registered by name to you.

Healthcare professionals and students as well as certain specialists engaged in the buying and selling of medicinal products, medicinal devices and products without an intended medical purpose must notify the Danish Medicines Agency if they receive financial support from a pharmaceutical or medical device company. Financial support is the payment of direct expenses for a professionally relevant activity abroad or an international, professionally relevant congress or conference in Denmark. A direct expense may be a registration fee, transportation, food or accommodation.

Examples of professionally relevant activities

• Conferences or congresses abroad  
• Courses or teaching abroad
• Study trips abroad
• Paid dinner abroad
• International conferences or congresses in Denmark

The examples below are based on the assumption that you are a covered healthcare professional, specialist or student within the professions covered:

• I am to participate on an advisory board abroad and must apply for permission to do so; should I also notify you of financial support?

Yes, if the company pays expenses related to your participation in the advisory board meeting abroad, you must not only apply for permission for the relationship but also notify us of financial support. You may notify us of both things in one form. In the form, you should select:

• ”Udføre en opgave for virksomheden” ('Performing a task for the company') and
• ”Tilhører til faglig aktivitet” ('Attending a professional activity')

In the box ”Udføre en opgave for virksomheden”, select advisory board member.

In the box ”Tilhører til faglig aktivitet”, select 'Other'. In the free-text box, please state that you are to be an advisory board member.

• I am to take part in training at a pharmaceutical or medical device company, and my transportation to the location will be paid for; should I notify the Agency of this?

If it is held abroad, yes. if it is held in Denmark, no.

• On a study trip, I was invited by another company for a sandwich; is this considered financial support?

Yes, if you receive food from a pharmaceutical or medical device company, it is considered financial support – there is no triviality threshold.

• My workplace has decided that I am to attend a congress abroad, and a pharmaceutical or medical device company is paying my expenses; should I notify the Agency of this?

Yes, when pharmaceutical or medical device companies pay the expenses related to your participation in a professionally relevant activity abroad or in an international congress or conference in Denmark, the rules on financial support apply, and the Danish Medicines Agency must be notified.

• I was invited as a fill-in to a congress abroad, taking someone else's place that a company has paid for; should I notify the Agency of this?

Yes, despite the fact that you are invited as a fill-in, it must be transparent that the expenses you incur in connection with your participation in the congress are being paid for.

Publication of professional relationships and financial support

Information about professional relationships or financial support will be published on our website on the start date and be publicly available for two years after the end date.