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.â€
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.â€
In April of 2007 the Director of the Enterprise and Industry Directorate General of the European Commission released its report for consultation on "current practice with regard to provision of information to patients on medicinal products." The report focuses on information publicly available on the internet from regulatory bodies or official sources in member states -- mostly of information on package leaflets, databases of approved drugs and regulatory reports, and other sources of information from regulatory bodies on approved drugs.
The report concludes, "Member States may not be in a position to fully address patients' needs in terms of the substance of information and the access via different means. In turn, the pharmaceutical industry possesses the key information on their medicines but this information can currently not be made available to patients and healthcare professionals through Europe."
The idea of a public-private partnership stems from the recent second progress report of the European Commission's High Level Pharmaceutical Forum that proposes "to organise a platform to bring together relevant stakeholders to explore ways to exchange good practices and on ways to overcome barriers to accessing information." Although the Commission does not support direct to consumer advertising, they are clearly suggesting that reliable information could come jointly from both industry and regulatory bodies.
Indeed, efforts that include industry (and their proven ability to communicate health care information to patients – aka consumers – in partnership with governments (with their ability to use the bully pulpit on behalf of the public health) is a potent alliance and the right way to proceed.
But not everyone agrees.
Here’s what the British Medical Journal has to say in a recent editorial:
“We think that a partnership between drug companies and drug regulatory authorities in the area of information … would be confusing. Therefore, we propose two areas of real partnership with the drug industry that would reinforce public trust in the system.
The first would entail a real commitment to waive confidentiality and give full access to data on the effectiveness and safety of drugs. Giving full access to all clinical trial protocols (not just those that are registered for publication purposes) and to the periodic safety update reports available to regulatory agencies would enhance transparency.â€
Does the BMJ really think that practicing physicians have the time or inclination to plow through thousands of pages of clinical trial data? And, anyway, isn’t that besides the point?
If “more information†is good for physicians – why isn’t it equally good for patients?
Or does the BMJ believe that only medical professionals should have access to information?
The BMJ editorial concludes by saying that"
“The most sensible way to protect public health would be to identify sources of unbiased and systematically reviewed information and maintain the current European legislation on drug promotion, while reinforcing the role of the European Medicines Evaluation Agency.â€
Here’s a link to the complete BMJ editorial:
http://www.ifpma.org/PressReviewEmail/PressReviewDetail.aspx?nID=8133&SD=LoB8AhN%2fJP9w%3d%3d
Is more government control and a continued policy of information denied to patients the BMJ’s idea of progress?
“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.â€
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.â€
In April of 2007 the Director of the Enterprise and Industry Directorate General of the European Commission released its report for consultation on "current practice with regard to provision of information to patients on medicinal products." The report focuses on information publicly available on the internet from regulatory bodies or official sources in member states -- mostly of information on package leaflets, databases of approved drugs and regulatory reports, and other sources of information from regulatory bodies on approved drugs.
The report concludes, "Member States may not be in a position to fully address patients' needs in terms of the substance of information and the access via different means. In turn, the pharmaceutical industry possesses the key information on their medicines but this information can currently not be made available to patients and healthcare professionals through Europe."
The idea of a public-private partnership stems from the recent second progress report of the European Commission's High Level Pharmaceutical Forum that proposes "to organise a platform to bring together relevant stakeholders to explore ways to exchange good practices and on ways to overcome barriers to accessing information." Although the Commission does not support direct to consumer advertising, they are clearly suggesting that reliable information could come jointly from both industry and regulatory bodies.
Indeed, efforts that include industry (and their proven ability to communicate health care information to patients – aka consumers – in partnership with governments (with their ability to use the bully pulpit on behalf of the public health) is a potent alliance and the right way to proceed.
But not everyone agrees.
Here’s what the British Medical Journal has to say in a recent editorial:
“We think that a partnership between drug companies and drug regulatory authorities in the area of information … would be confusing. Therefore, we propose two areas of real partnership with the drug industry that would reinforce public trust in the system.
The first would entail a real commitment to waive confidentiality and give full access to data on the effectiveness and safety of drugs. Giving full access to all clinical trial protocols (not just those that are registered for publication purposes) and to the periodic safety update reports available to regulatory agencies would enhance transparency.â€
Does the BMJ really think that practicing physicians have the time or inclination to plow through thousands of pages of clinical trial data? And, anyway, isn’t that besides the point?
If “more information†is good for physicians – why isn’t it equally good for patients?
Or does the BMJ believe that only medical professionals should have access to information?
The BMJ editorial concludes by saying that"
“The most sensible way to protect public health would be to identify sources of unbiased and systematically reviewed information and maintain the current European legislation on drug promotion, while reinforcing the role of the European Medicines Evaluation Agency.â€
Here’s a link to the complete BMJ editorial:
http://www.ifpma.org/PressReviewEmail/PressReviewDetail.aspx?nID=8133&SD=LoB8AhN%2fJP9w%3d%3d
Is more government control and a continued policy of information denied to patients the BMJ’s idea of progress?
