Information about prescription drugs
On Oct. 11, 2011, the European Commission published revised proposals to amend Regulation (EC) No. 726/2004 and to amend Directive 2001/83/EC. The content of these proposals is to clarify the form in which companies may inform the public about prescription-only medicines.
The growing interest of patients in their treatment and prescribed medicines has been accompanied by a rapid increase in the possibilities of obtaining this information from a wide variety of sources. With so many possible sources of information, it can often be difficult to assess which of these drug information sources are reliable.
Particularly in the case of information sources on the Internet, care should be taken to ensure that the drug information is accurate, unambiguous and up to date.
The proposals presented by the European Commission maintain the current ban on advertising prescription-only medicines.
Regulations:
- Certain information about prescription drugs should be permitted, such as information on the label and package insert, information about prices and clinical trials, and instructions for use.
- Information about prescription drugs will be permitted only through limited communication channels, such as information on registered websites or printed information available to the public upon request. Publication in general print media will not be permitted.
- The information must meet recognized quality criteria. For example, it must be neutral, meet patient needs and expectations, be based on facts, be factually accurate and understandable, and not misleading.
- In principle, information that has not been previously approved must be reviewed by the relevant authorities before it is made available.
These proposals are now being discussed in both the European Parliament and the Council.
Further information:
Proposal to amend Regulation (EC) No. 726/2004.
Proposal to amend Directive 2001/83/EC
