Draft bill amending the Danish Medicines Act and a new Danish Access to Public Administration Files Act

The Danish Medicines Act

The Danish Ministry of the Interior and Health has issued a draft bill amending the Danish Medicines Act.

The draft bill mainly focuses on the illegal distribution of drugs and strengthening of the control efforts. The fol­lowing amendments are proposed:

• the Danish Medicines Agency will have legal pow­ers to seize and confiscate illegally im­ported and illegally distributed drugs
• the Danish Medicines Agency will have ex­panded access to inspect companies that ille­gally distribute pharmaceutical products
• it will be illegal for an internet provider to trans­mit access to a website selling illegal drugs. As a consequence of this prohibition the Danish Medicines Agency will have legal powers to re­quest the internet provider to block up the ac­cess to websites selling illegal drugs
• it will be legal for the holder of the marketing au­thorisation to buy illegal drugs with the in­tent to examine whether the illegal drug is a counterfeit version of the drug covered by the marketing authorisation

The draft bill also includes a proposal to increase digital communication between the Danish Medicines Agency and the pharmaceutical companies. Finally, it is pro­posed to extend the category of health care personnel who may receive advertisements for prescription drugs. It is suggested that midwives, medical laboratory tech­nologists, clinical dieticians and radiographers should be included as health care personnel.

If the bill is passed, it will come into force from 1 July 2011.

The Danish Access to Public Administration Files Act

The Danish Ministry of Justice has submitted a bill for a new Danish Access to Public Administration Files Act in the Danish Parliament.

The purpose of the bill is to improve the existing Access to Public Administration Files Act in relation to transpar­ency and democratic control. The main proposals in the bill are:

• the scope of the Act will be expanded meaning that the interest organisations Local Govern­ment Denmark (KL) and Danish Regions (Dan­ske Regioner) will be comprised by the Act as well as companies where the Danish Govern­ment owns more than 75% of the shares and companies acting on behalf of the Government, the Danish Regions and the Danish Municipali­ties
• it will no longer be a requirement that the party requesting right of access to a case has specific knowledge about the case or the documents in the case. The requesting party must, however, be able to identify the theme of the case or documents comprised by the request for access to the documents or the case. It is further pro­posed that even though the identification re­quirement is met, the public authority is not obliged to grant access if handling the request will require excessive resources
• the new Act will impose certain restrictions on the right of access. If adopted there will no longer be right of access to calendars (e.g. a minister's calendar), documents exchanged be­tween authorities in relation to ministerial ser­vices and documents prepared and exchanged between the ministers and members of the Par­liament in connection with legislative activity or other similar political processes

If the bill is passed, it will come into force from 1 January 2012.

Both bills are being discussed in the Danish Parliament at the moment. We will inform of any material changes to the bills and inform of the bills when passed.   

If you have any questions to the bills, please contact Mikkel Vittrup, Attorney-at-Law, mvi@plesner.com or Annika Valla Broman, Attorney-at-Law, avb@plesner.com.