Draft bill amending the Danish Medicines Act and a new Danish Access to Public Administration Files Act
The Danish Government has issued a new 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, firstname.lastname@example.org or Annika Valla Broman, Attorney-at-Law, email@example.com.