European Law Report - Pharmaceutical reform
The European Commission has published a "communication" containing a pharmaceutical package which sets out the proposed action the EU will be taking by means of legislative measures to introduce reform in the pharmaceutical sector. The reform is aimed...
The European Commission has published a "communication" containing a pharmaceutical package which sets out the proposed action the EU will be taking by means of legislative measures to introduce reform in the pharmaceutical sector.
The reform is aimed at tackling the growing issues of counterfeiting and illegal distribution of medicines in the EU, and to better protect patients by strengthening the EU's system for safety monitoring on medicines.
Citizens will benefit from the actions outlined in many ways. They will be better protected against important health threats such as counterfeit medicines or unsafe products. A medicinal product will have safety features like a barcode to guarantee traceability, an authenticity feature to ensure that what the consumers are getting is what they asked for, and a tamper-proof seal on the package to guarantee that the product has not been opened.
These protective measures, however, are not intended to impede the practice of repackaging, which allows parallel trade in medicines in the EU. Parallel traders normally purchase medicines in low-priced countries of the EU and sell them, after repackaging them, at a discount in other countries where the prices are higher. Yet, each actor in the supply chain of pharmaceuticals, including parallel traders, must have a manufacturing authorisation to allow them to repackage medicines legally.
Another important aspect of the pharmaceutical reform package is the proposal concerning prescription-only medicinal products. Current EU legislation bans direct-to-consumer advertising for prescription medicines. The pharmaceutical industry has long lobbied for change in this respect. Advertising rules for prescription medicines could be relaxed as a result of the proposed rules, which will allow pharmaceutical companies to make information on their prescription medicines available directly to the public.
This is one of the most controversial initiatives, even though the new rules will maintain the general ban on direct advertising, since the new measures will allow industry to provide information to the public through the media. Yet, only certain types of information on prescription-only drugs will be allowed, and only specified communication channels will be permitted, such as health-related publications and registered websites.
Moreover, the information conveyed must fulfill common quality criteria by being objective, evidence-based, up-to-date, reliable, factually correct, sourced, dated and understandable to the public.
The communication still has some way to go before adoption, and it remains to be seen whether certain controversial aspects of it will withstand the test of time.
• Dr Grech is an associate with Guido de Marco & Associates and heads its European law division.
The reform is aimed at tackling the growing issues of counterfeiting and illegal distribution of medicines in the EU, and to better protect patients by strengthening the EU's system for safety monitoring on medicines.
Citizens will benefit from the actions outlined in many ways. They will be better protected against important health threats such as counterfeit medicines or unsafe products. A medicinal product will have safety features like a barcode to guarantee traceability, an authenticity feature to ensure that what the consumers are getting is what they asked for, and a tamper-proof seal on the package to guarantee that the product has not been opened.
These protective measures, however, are not intended to impede the practice of repackaging, which allows parallel trade in medicines in the EU. Parallel traders normally purchase medicines in low-priced countries of the EU and sell them, after repackaging them, at a discount in other countries where the prices are higher. Yet, each actor in the supply chain of pharmaceuticals, including parallel traders, must have a manufacturing authorisation to allow them to repackage medicines legally.
Another important aspect of the pharmaceutical reform package is the proposal concerning prescription-only medicinal products. Current EU legislation bans direct-to-consumer advertising for prescription medicines. The pharmaceutical industry has long lobbied for change in this respect. Advertising rules for prescription medicines could be relaxed as a result of the proposed rules, which will allow pharmaceutical companies to make information on their prescription medicines available directly to the public.
This is one of the most controversial initiatives, even though the new rules will maintain the general ban on direct advertising, since the new measures will allow industry to provide information to the public through the media. Yet, only certain types of information on prescription-only drugs will be allowed, and only specified communication channels will be permitted, such as health-related publications and registered websites.
Moreover, the information conveyed must fulfill common quality criteria by being objective, evidence-based, up-to-date, reliable, factually correct, sourced, dated and understandable to the public.
The communication still has some way to go before adoption, and it remains to be seen whether certain controversial aspects of it will withstand the test of time.
• Dr Grech is an associate with Guido de Marco & Associates and heads its European law division.