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Decisions and practices no. 3

05 November 2008

Author names are comprised by the rules on access to documents
Large fine for advertising for not authorised medicinal products
Illegal use of information from the Medicine Profile
No right of cancellation for faulty price notifications


Author names are comprised by the rules on access to documents

Information about the names of the authors of a periodic safety update report (PSUR) submitted to the Danish Medicines Agency by a company is not exempt from the rules on access to documents. This applies even if the PSUR concerns a potentially controversial medicinal product.

In connection with the processing of an application to the Danish Medicines Agency about access to the PSUR for the medicinal product Equasym® under the Access to Public Administration Files Act, doubt arose as to whether the names of the authors of the PSURs and the names of the persons who had performed the medical and regulatory reviews could be disclosed.

The UCB Nordic, which holds the marketing authorisation of Equasym®, believed that the names of the authors and others ought to be deleted before the PSURs were released. One of the company’s arguments was that Equasym® is used for hyperactive children (ADHD). This particular application of the medicinal product has caused debate in the media, and it has given rise to significant emotional reactions from the public.

UCB Nordic believed that any information on names was exempt from the rules on access to documents under section 12(1)(i) or (ii), or section 13(1)(vi) of the Danish Access to Public Administration Files Act.

Exemptions from the right of access to documents
The general rule is that anyone can obtain access to documents submitted to or drawn up by a Danish public authority as part of the administrative processing of a case, cf. section 4(1) of the Access to Public Administration Files Act.
However, certain types of information are exempt from the rules on access to documents. Some of the information exempt from the rules is information about the situation of private individuals, including their financial situation, cf. section 12(1)(i), and information about trade secrets etc. of considerable financial significance to the person whom the information concerns, cf. section 12(1)(ii).
Moreover, the right of access to documents can be restricted if it is required in order to safeguard private or public interests and secrecy is required due to the special character of the matter, cf. section 13(1)(vi).

The Danish Medicines Agency decided to grant access to documents
Notwithstanding the special circumstances pointed out by UCB Nordic, the Danish Medicines Agency assessed 

  • that the fact that the authors etc. had contributed to the PSURs could not be considered as private affairs safeguarded under section 12(1)(i) of the Access to Public Administration Files Act,
  • that the disclosure of names does not carry any obvious risks of the UCB Nordic suffering financially or otherwise, cf. section 12(1)(ii), and
  • that no private or public interests were at stake to an extent that could substantiate the use of the provision in section 13(1)(vi) of the Access to Public Administration Files Act.

The Danish Medicines Agency therefore decided to disclose the names as part of the access to documents.

Complaint about the decision
The UCB Nordic filed a complaint with the Danish Ministry of Health and Prevention about the Danish Medicines Agency’s decision.
In its assessment of the complaint, the Ministry especially emphasised

  • that the fact that a person is employed at a specific company within a given work area is not sensitive information that can be exempted from the rules on access to documents under section 12(1)(i) of the Access to Public Administration Files Act, and
  • that the risk that authors etc. of a PSUR may be contacted by third parties, and should therefore not wish to continue their work activities, does not entail a risk to the company which is so obvious that the names can be exempted from the rules on access to documents under section 12(1)(ii) of the Access to Public Administration Files Act.

The Ministry therefore upheld the Danish Medicines Agency’s decision.

The Danish Act on Processing of Personal Data
The case also comprised an element that was to be considered under the Danish legislation on personal data, as the name information concerned is considered personal information pursuant to the Act on Processing of Personal Data.

Pursuant to section 6(1)(iii) of the Act on Processing of Personal Data, an authority is entitled to process, hereunder pass on, personal information, if this processing is required in order for the authority to meet a judicial obligation resting with the entity responsible for the data (the authority). Under section 6(1)(vi) of the Act, the processing of personal information may also take place if this processing is required for the purposes of the execution of a task that falls within the obligations and responsibilities of a public authority.

In its decision, the Ministry of Health and Prevention stated that the Danish Medicines Agency was entitled to process (disclose) the names of the authors etc. since it was required in order for the Agency to meet a judicial obligation to grant access to documents under the Access to Public Administration Files Act. Moreover, the disclosure was required due to the execution of the Danish Medicines Agency’s tasks as an authority under the Access to Public Administration Files Act.

Karsten Jørgensen


Large fine for advertising for not authorised medicinal products

A company that advertised for not authorised medicinal products in a coupon book has been fined DKK 150,000. This judgment has been appealed to the Danish High Court. The publisher of a coupon book has agreed to pay a fine of DKK 75,000.

In August 2006, the company M advertised for several natural remedies in a coupon book, i.e. a collection of advertisements from different companies.
The Danish Medicines Agency classified these products as medicinal products and notified M that a medicinal product must be authorised before it may be sold in Denmark. Moreover, the Danish Medicines Agency notified M that under section 64 of the Danish Medicines Act, it is illegal to advertise for medicinal products that are not sold legally in Denmark.

In November 2006 and January 2007, M placed new advertisements for not authorised natural remedies in the same coupon book. This caused the Danish Medicines Agency to report the matter to the police.

A fine of DKK 150,000
On 29 May 2008, the Frederiksberg District Court (Retten på Frederiksberg) delivered a judgment in the case: M was sentenced to a fine of DKK 150,000 and was moreover ordered to pay the costs of the proceedings. The Court emphasised that M in August 2006 was notified that advertising for not authorised natural remedies constitutes a violation of the Danish Medicines Act. The subsequent advertising in November 2006 and January 2007 therefore constituted a deliberate breach of the rules.
M has appealed the judgment to the Danish High Court (Landsretten).

The publisher is also fined
The Danish Medicines Agency also reported the publisher of the coupon book, A, to the police as A was notified about the illegal advertisements in November 2006. Nevertheless, A chose to issue yet another coupon book with illegal advertisements in January 2007.
Faced with a fine notice from the police, A pleaded guilty of violation of the Danish Medicines Act and accepted to pay a fine of DKK 75,000. This part of the case was therefore closed before the case came to court.

Karsten Jørgensen


Illegal use of information from the Medicine Profile

Doctors are not entitled to use the Medicine Profile to gather information about patients’ affiliation etc. in connection with dissolution of a practice with two or more partners.

Within a few hours, a doctor looked at the personal medicine profiles of as many as 83 patients. In all 83 instances the doctor’s searches gave him access to information about the individual medicine user’s address, general practitioner and purchase of prescription-only medicinal products.
Based on the unusually large number of searches within a short period of time the doctor’s access to the Medicine Profile was blocked.

Dissolution of practice
The doctor subsequently contacted the Danish Medicines Agency in order to gain access to the Medicine Profile again.
He stated that in connection with the dissolution of a practice where he was partner he had used the Medicine Profile to investigate the patients’ current affiliation to ensure that no records of relevance to the patients’ current general practitioner were lost. He had not, however, looked at the patients’ medicine consumption.

Conditions for legal use of the Medicine Profile
Under section 4(1) of the executive order on the Danish Medicines Agency’s register of Personal Electronic Medicine Profiles (the Medicine Profile), two conditions must be met before a doctor is entitled to search for information about a medicine user:

  • First of all, the doctor must be treating the patient.
  • Second of all, the information must be relevant to the treatment.

These conditions were not met as the doctor had not looked up information in the Medicine Profile as a necessary part in the process of treating the patients. On the contrary: He did not treat the patients at all. 
The doctor’s use of the Medicine Profile was therefore illegal.

Reported to the police
According to the present information, the doctor had – per se – looked up information in the Medicine Profile with good intentions, i.e. he intended to hand over the record information to each patient’s current general practitioner.
However, due to the very sensitive personal information contained in the Medicine Profile, it is crucial that all doctors limit their use of the Medicine Profile to the purposes stipulated by Danish legislation. The Danish Medicines Agency has therefore reported the doctor to the police.

Karsten Jørgensen


No right of cancellation for faulty price notifications

A pharmaceutical company cannot regret its notification of price or supply estimates after expiry of the notification deadline, even if the company has made a mistake in its notification.

A company with a pharmacy-only medicinal product on the Danish market must, under section 77(1) of the Danish Medicines Act, notify the price of the medicinal product – and changes to the price – to the Danish Medicines Agency. Furthermore, the company must notify a supply estimate under the executive order on Medicine Prices and supply conditions (the executive order on medicine prices).

The notification of both price and supply estimate must be in the hands of the Danish Medicines Agency no later than 14 days before the price is to enter into force. The Danish Medicines Agency subsequently communicates the new prices to pharmacies via Medicine Prices.

Price affects demand
Medicinal products marketed in Denmark are divided into reimbursement groups consisting of synonymous medicinal products. Within a reimbursement group pharmacies must always offer the least expensive medicinal product to citizens.
The demand within a reimbursement group is therefore primarily directed at the least expensive medicinal product(s) in the group.

Via the Danish Medicines Agency’s notification system DKMAnet, a company notified a price change of a medicinal product to the Danish Medicines Agency as well as the number of packages that the company expected to be able to deliver to the market for 14 days (supply estimate). After this, the company submitted no changes to the notification prior to the expiry of the notification deadline.

The company’s change of the price of the medicinal product entailed that it would become the least expensive product in its reimbursement group. The company had notified that it expected to be able to supply 432 packages and the Danish Medicines Agency did not believe this to be sufficient to cover the market demand. The average consumption in the previous price periods was approximately 1,800 packages.

Insufficient supply estimate 
Under section 6(1) of the executive order on medicine prices, the Danish Medicines Agency must refrain from publishing the price of a medicinal product in Medicine Prices, if

  • the price of the medicinal product is the least expensive in the reimbursement group, and
  • the Danish Medicines Agency assesses that the pharmaceutical company's supply estimate is insufficient to meet the full demand for seven days counting from the day when the price enters into force.

Subsequently, the Danish Medicines Agency informed the company that the medicinal product would not be included in Medicine Prices in the next price period as the price was the least expensive in the reimbursement group and the supply estimate was insufficient.

Mistake in the price notification
Shortly after the notification deadline expired the company informed the Danish Medicines Agency that it had made a mistake in connection with the price notification. It also informed the Agency of the price which it was supposed to have notified. The desired price was higher than the price notified and it would entail that the medicinal product would no longer be the least expensive product in the reimbursement group, and therefore it would meet the criteria for inclusion in Medicine Prices.

Under section 3(2) of the executive order on medicine prices the notification must take place no later than Monday at 20:00, 14 days before the relevant price period becomes effective. Within the deadline it is possible to change or withdraw any notification as many times as desired.

No changes after the deadline
The Danish Medicines Agency informed the company that it was not possible to change the notification after the deadline as the notification deadline is absolute. Thus, it is not possible to regret a notification after the deadline even though the mistake was accidental.

The executive order on medicine prices does not entitle the Danish Medicines Agency to make an exemption from the notification deadline.
If it were possible to make changes after the expiry of the deadline it would result in an actual extension of the notification deadline. Any such extension would give companies the opportunity to change their notifications after having seen the consequences of the notification.
In the case at hand, the consequence was that the package was deleted from Medicine Prices.

Sameer Kohli


Danish Medicines Act
Section 77(1)(i)
“Anyone who places a pharmacy-restricted medicinal product on the Danish market shall notify the Danish Medicines Agency of the pharmacy cost price and of any changes of such price of the concerned medicinal product made up per package size no later than 14 days prior to the price coming into force.”

Executive order on Medicine Prices and supply conditions

Section 3(1)(ii)
“Pharmaceutical companies must notify the Danish Medicines Agency of the number of packages of the medicinal product concerned, which the pharmaceutical company can supply to pharmacies from the date on which the price or the price change ... is to enter into force (supply estimate) for substitutable pharmacy-only medicinal products eligible for reimbursement...”

Section 3(2)

“Notification under subsection 1 [price and supply estimate] must be in the hands of the Danish Medicines Agency no later than Monday at 20:00, 14 days before the entry into force of the relevant price period.”

Section 3(6)

“It is the responsibility the pharmaceutical companies to ensure that the electronic notification arrives at the Danish Medicines Agency in time, and that the notification has the desired content...”