Peter Pitts
In April of 2006, James Copping (Principal Administrator, European Commission Enterprise & Industry Directorate-General) had this to say about rethinking the EU Commission’s position on information-to-patients:
“From the Commission’s point of view, we want a system where patients can be empowered to take an equal part in health care decisions. To do that, they need more information and we all want to make high-quality information available as soon as possible. We believe that all stakeholders have a role to play to provide this information, but the tricky issue for us is to find the appropriate framework which national regulatory authorities can live with.”
Copping continued as to possible ways to achieve that goal:
“The pharmaceutical industry has a lot to contribute because of their resources, skills and expertise and we have seen in the working group that the industry plays a constructive part. It’s amazing to me that an industry which plays such an important part of our health care is often seen on par with the tobacco or the oil industry. It’s not clear to me why this is the case, but we need to develop good working relationships between all of us. We all agree that we need good quality information, but none of us can do it alone.”
Well, almost two-years to the day, the controversial EU-wide ban on pharmaceutical advertising may soon end – although what this means, precisely, is unclear, as is what kind of information may become available.
The European commission plans to allow drug companies to give "information" about their drugs to the public on TV, the internet and in print.
The consultation document from the enterprise and industry directorate-general says: "It should be possible for the pharmaceutical industry to disseminate information on prescription-only medicines through TV and radio programmes, through printed material actively distributed, through information in printed media or through audiovisual and written material provided to patients by healthcare professionals." The consultation period closed on April 7. An earlier Commission report had found unequal access to health and medicines information throughout the EU, which it said could be harmful to public health.
Leaders of the European pharmaceutical industry have once again stressed that they are not seeking, and have never sought, direct-to-consumer advertising for prescription medicines to be permitted within the European Union. However, according to Arthur Higgins (EFPIA president and chief executive of Bayer HealthCare AG.), “After years of debate, we call on all European institutions to develop a patient-centered EU framework for information provision without further delay.”
EFPIA is also concerned at the EU proposals for a governance system for monitoring the information provided by the industry. The Commission suggests that the structure of enforcement could take place on three different levels – an EU advisory committee, the EU national authorities and national “co-regulatory” bodies – but EFPIA believes that this could potentially lead to a “patchwork” of very different interpretations and implementations in national laws, as it is currently the case, and thus fail to adequately address the European dimension of the current shortcomings.
Instead, the industry proposes an alternative system based on an EU-wide “health information” Code of Conduct, including effective quality assessment procedures for information, ex-post control mechanisms (with involvement of third/independent parties) and robust enforcement procedures in case of breaches including sanctions as well as fines. Such a Code could work alongside and complement the legislative change envisaged by the European Commission later this year.
Posted by Peter Pitts on April 15, 2008 7:18 AM
In April of 2006, James Copping (Principal Administrator, European Commission Enterprise & Industry Directorate-General) had this to say about rethinking the EU Commission’s position on information-to-patients:
“From the Commission’s point of view, we want a system where patients can be empowered to take an equal part in health care decisions. To do that, they need more information and we all want to make high-quality information available as soon as possible. We believe that all stakeholders have a role to play to provide this information, but the tricky issue for us is to find the appropriate framework which national regulatory authorities can live with.”
Copping continued as to possible ways to achieve that goal:
“The pharmaceutical industry has a lot to contribute because of their resources, skills and expertise and we have seen in the working group that the industry plays a constructive part. It’s amazing to me that an industry which plays such an important part of our health care is often seen on par with the tobacco or the oil industry. It’s not clear to me why this is the case, but we need to develop good working relationships between all of us. We all agree that we need good quality information, but none of us can do it alone.”
Well, almost two-years to the day, the controversial EU-wide ban on pharmaceutical advertising may soon end – although what this means, precisely, is unclear, as is what kind of information may become available.
The European commission plans to allow drug companies to give "information" about their drugs to the public on TV, the internet and in print.
The consultation document from the enterprise and industry directorate-general says: "It should be possible for the pharmaceutical industry to disseminate information on prescription-only medicines through TV and radio programmes, through printed material actively distributed, through information in printed media or through audiovisual and written material provided to patients by healthcare professionals." The consultation period closed on April 7. An earlier Commission report had found unequal access to health and medicines information throughout the EU, which it said could be harmful to public health.
Leaders of the European pharmaceutical industry have once again stressed that they are not seeking, and have never sought, direct-to-consumer advertising for prescription medicines to be permitted within the European Union. However, according to Arthur Higgins (EFPIA president and chief executive of Bayer HealthCare AG.), “After years of debate, we call on all European institutions to develop a patient-centered EU framework for information provision without further delay.”
EFPIA is also concerned at the EU proposals for a governance system for monitoring the information provided by the industry. The Commission suggests that the structure of enforcement could take place on three different levels – an EU advisory committee, the EU national authorities and national “co-regulatory” bodies – but EFPIA believes that this could potentially lead to a “patchwork” of very different interpretations and implementations in national laws, as it is currently the case, and thus fail to adequately address the European dimension of the current shortcomings.
Instead, the industry proposes an alternative system based on an EU-wide “health information” Code of Conduct, including effective quality assessment procedures for information, ex-post control mechanisms (with involvement of third/independent parties) and robust enforcement procedures in case of breaches including sanctions as well as fines. Such a Code could work alongside and complement the legislative change envisaged by the European Commission later this year.
Posted by Peter Pitts on April 15, 2008 7:18 AM
