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Controversy, Drug-patient Info in Europe
  Patient info: EU curbs on drugmakers must remain - consumerists
10 December 2007
With the European Commission due to publish its long-awaited report on the provision of medicines information to patients before the end of the month, consumer activists have urged it to resist what they call "significant pressure" to let pharmaceutical manufacturers address patients directly.
"The inherent conflict of interest of pharmaceutical companies in providing information directly to patients is so obvious that we can not imagine that any policy would allow it in Europe," said Monique Goyens, director general of the European Consumers Organisation (BEUC), an umbrella group which represents 41 consumer associations. "Patients deserve information which is unbiased and of the highest possible quality, and other more reliable and independent sources, [such as the European Medicines Agency], must be promoted," she added.
Ms Goyens was speaking at a half-day conference of European legislators, industry, patient groups and other stakeholders held at the European Parliament to discuss the issue and co-hosted by the three European Parliament representatives in the EU High-Level Pharmaceutical Forum - Francoise Grossetete, Dagmar Roth-Behrendt and Jorgo Chatzimarkakis.
Brian Ager, director general of the European Federation of Pharmaceutical Industries and Associations, told delegates there was an urgent need for reform in the European Union to reduce current inequalities among different population groups and between member states in accessing high-quality information. "We firmly believe that this can only be achieved through patient information partnerships, as they already exist in few member states, involving all stakeholders who commit themselves to provide quality information of the highest standard," he said.
Hubertus Cranz, director general of the Association of the European Self-Medication Industry called for legislation to allow the addition of non-promotional information on the medicine package, so that companies could for example list website addresses providing valuable additional information on particular conditions, such as smoking cessation. Mr Cranz also noted the importance of health professionals in providing information on non-prescription medicines and the need to improve doctors' and pharmacists' training so that their support potential for consumers is fully developed.
Information or advertising?
However, Jim Murray, an advisor to BEUC, said that recent efforts to lift some of the current restrictions on information provision by drugmakers were too narrow, not based on any overall or coherent policy and would not lead to better health outcomes; in fact worse ones were more probable and with increased costs, he said. If the restrictions were lifted, it would be impossible to make an effective distinction between information and advertising, he claimed, and forecast that the results would be: a bias towards high-margin medicines and the "medicalisation" of certain conditions; a bias against non-drug therapies and improving lifestyles; increased pressure on the doctor/patient relationship and on health care budgets - "as information is pumped out about medicines that are being assessed for reimbursement or that are subject to emerging doubts in the pharmacovigilance process;" and a move toward direct reporting to the companies of adverse effects.
Mr Murray also said that the pressure for lifting the restrictions had come from drugmakers, including the US industry, plus the European Publishers Council and Gunter Verheugen, vice-president of the European Commission and Commissioner in charge of Enterprise and Industry, who has referred to the right of pharmaceutical companies to provide information about their products. Mr Murray said that BEUC does not believe that the current restrictions are an abuse of those rights, but added: "if they feel otherwise, the companies have the means to seek a remedy in the courts."
Following the adoption of its report on the provision of information to patients by the end of 2007, the Commission is expected to announce its proposals for legislative change in fourth-quarter 2008. By Lynne Taylor
EC completes public consultation on information provision
11 July 2007
The ongoing effort to improve a patient's efundamental right to know' reached another milestone recently after the European Commission completed the public consultation on its report on the provision of medicinal product information to patients. In response to the consultation, the European Patients' Forum has called for pharmaceutical companies to be allowed to act as a validated non-promotional source of product information to patients.
Patient organisations have been fighting for harmonised pan-European proposals setting out an information strategy to ensure good-quality, objective, reliable and non-promotional information on medicinal products. Of particular relevance to the pharmaceutical industry is the issue of an existing legislative framework that does not permit pharmaceutical companies to respond to enquiries from patients about their medicines.
The legal situation governing information for patients has not changed fundamentally over the last 15 years. Three years ago, however, the amended pharmaceutical Directive 2004/27/EC tackled this inertia by stating: "Within three years of entry into force of Directive, the Commission shall, following consultation with patients' and consumers' organisations, Member States and other interested parties, present to the European Parliament and the Council a report on current practice with regard to information provision - particularly on the Internet - and its risks and benefits for patients."
A draft report on current practices in the provision of information on medicinal products to patients went out for consultation in April.
Since 2004, several Commission initiatives and public debates have focused on the need to address the lack of a Community framework for patient information, so as to respond better to the needs of patients and the overall interests of public health. The European Patients' Forum (EPF) was consulted extensively on the draft report and has called for a number of amendments to the proposals.
Rui Santos Ivo, the European Commissioner responsible for the report, is now collating the responses to the consultation. The draft report looked at existing mechanisms and technologies in the EU for the provision of information to patients in terms of patients' needs, the role of the internet and the parts played by different stakeholders, he explained. The draft report identifies a number of issues stemming from the existing legal framework and different practices in the Member States.
"We have just started analysing the different contributions received," he said. "The document also intends to set the basis for the Commission to consider a strategy on information to patients by recognising important developments in society concerning the patient's role, rights and responsibilities, and also that access to reliable and good quality information is essential. It highlights the importance of action at EU level in order to overcome issues such as inequalities in access and EU quality standards for information."
Provision of info by pharmas
Clearly recognising that patient organisations are key drivers for health democracy at EU level, the EPF argues that today's patient is changing from the passive recipient or bystander to an informed and political actor.
"All patients have a fundamental and legitimate human right to access quality information about their health, medical conditions and the availability of treatments, including knowledge of the best available management of their disease," the EFP stated. "This right implies that the same information that is available to doctors should also be available to patients."
Among its concerns, the EPF drew attention to current legislation governing the provision of information to patients by pharmaceutical companies. "EPF and our patient allies resist strongly direct-to-consumer advertising on prescription medicines (DTCA)," it stressed. Nonetheless, the EPF believes there is increased consensus on the dividing line between access to quality information and DTCA.
"Pharmaceutical companies should be able to be a source of validated non-promotional information alongside other sources, on their products. However, it is crucial to ensure that when patients seek information from pharmaceutical companies, they get full information, including, for example, negative side-effects," the EFP commented.
The redrafted report incorporating comments from patient representatives will be presented to the European Parliament and Council later this year. By Peter Mansell
Draft report on patient information mulls wider role for industry
25 April 2007
Regulatory authorities in the EU member states "may not be in a position to fully address patients' needs in terms of the substance of information [on medicines] 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 throughout the EU".
This paradox, noted in the conclusions to a draft report from the European Commission on current practices in the provision of information on medicinal products to patients, sums up the arguments for a more active industry role in a rapidly proliferating field where official, regulated or validated sources of information collide with the relative free-for-all of the internet. If the Commission's tone is noncommital, it reflects the political sensitivities of a discussion that consumer groups claim is a prelude to the back-door introduction of direct-to-consumer advertising of prescription drugs.
The Commission itself insists this is not the case, nor is there anything in the document put out for consultation until 30 June that suggests otherwise. The balance of benefits and risks in providing drug information to patients "indicates the need for clear rules that apply to information, ensuring its objectivity and avoiding any promotional character", comments the Commission's Directorate General for Enterprise and Industry. The moot point, though, is when that information shades into advertising. Consumer groups such as Health Action International argue that industry's commercial imperatives make it incapable of supplying anything other than promotional information.
What the draft report does say is that the pharmaceutical industry "has the potential to be an important source of information to respond to the growing demand for more and better information from patients" - provided there are "adequate rules to ensure reliability, objectivity and quality of information". Industry believes it should have the same right as non-industry bodies to provide quality information on its own products, the Commission points out.
Pharmaceutical companies also share the view of many patient organisations that what matters is the availability and quality of the information, rather than its source, the report adds. A number of these organisations also acknowledge the role of industry as a legitimate source of information on its own products, specifically through epull' mechanisms "whereby the patient is actively seeking out information and needs to know where and how to access it". There is little support, however, for information provision that is not in response to patient demand, the Commission says.
The draft report ticks all the now familiar boxes about the hunger for health information, patient empowerment and the shift towards epartnership' between more informed patients and healthcare professionals. But it also makes clear that the problem is not so much lack of information on medicines, or of efforts to provide it by regulatory authorities (some of them in public-private partnerships with industry), the Commission or the European Medicines Agency; rather, it is disparities of access, the varying reliability of the information provided and the lack of harmonisation in a field that to date has not been subject to specific EU legislation.
The wide diversity of approaches to information provision taken by the member states in the absence of a clear EU mandate has "created obstacles and uncertainties from a Community perspective", the Commission comments. These include unequal access to information, determined mainly by member-state policy but also by ancillary factors such as technological skills, language, income and age; the lack of EU quality standards on information to patients, raising the risk of negative health consequences due to wrong, misleading or confusing information; and the risk that lack of information will lead to uninformed choices such as late diagnosis.
On the other hand, an increase in the quality and "appropriateness" of information on medicines "would be expected" to contribute to better conditions and more efficient use of resources in the health sector, the Commission maintains. "Better informed patients are expected to adhere better to treatments and to better understand clinical decisions," it adds. "This should lead in the long term to social and economic benefits."
Review obligation
The EU's review of its pharmaceutical legislation introduced an obligation in Directive 2001/83/EC for the Commission to present a report to the European Parliament and Council during 2007 on "current practice with regard to information provision - particularly on the Internet - and its risks and benefits to patients". The Commission was also asked, "if appropriate", to come up with proposals "setting out an information strategy to ensure good-quality, objective, reliable and non-promotional information on medicinal products and other treatments", as well as addressing the question of liability attaching to the information source.
Proposals during the pharmaceutical review to allow selective provision of drug information by industry on demand were thrown out by the European Parliament in 2004. The discussion has continued, though, through the Pharmaceutical Forum, the high-level EU initiative set up by the Commission in June 2005 to take forward outstanding issues from the G10 medicines process.
One of these was information for patients. A technical working group addressing this issue has been set up as part of the Forum, whose membership includes health ministers, members of the European Parliament and representatives of 10 stakeholder organisations spanning industry and public health interests. The Information to Patients Working Group provided input to the Commission's draft report and, following a public consultation, will be making proposals to the next meeting of the Pharmaceutical Forum at the end of June. By Peter Mansell
Drugmakers "OK to give patients non-promotional info"
03 October 2006
Patient access to medicines across the European Union is currently very unequal and, while improving this will require a long-term approach rather than short-term budget fixes, it does not mean new legislation from Brussels, the European Commission has said.
To be able to pay for much-needed drug innovations, EU states need to learn from each other, said EU Industry Commissioner Guenter Verheugen. He added: "the objective is not to spend more, but to spend more intelligently."
The Commissioner was speaking in Brussels at the first meeting of the EU Pharmaceutical Forum, a high-level advisory group set up examine the effects of pharmaceutical innovation on EU national health systems and make recommendations on: drug pricing and reimbursement, the use of Relative Effectiveness Assessment (REA) for new products; and how patients should receive information about the drugs they are prescribed.
"Europe is no longer the pharmacy of the world. We need to look urgently at the structural issues affecting the competitiveness of the industry and respond to these challenges," he said. The only way forward is through close cooperation between all member states, the European Parliament and all other stakeholders, including the industry, he added, and warned: "isolated action by any of us is doomed to fail."
Turning to patient information, the Commissioner described the current situation as unacceptable. "If you can speak English and use a computer, you already have as much information on pharmaceuticals as you could possibly want. What you get, however, are often Internet sites of dubious quality or even sources from outside the EU offering promotional material rather than information," he said.
The pharmaceutical industry should have the right to product non-promotional information for patients about medicines and diseases and to publish it, he told the meeting. This information could be provided on a self-regulatory basis but subject to a "robust" system of control and quality assurance "without creating a big bureaucracy," he suggested.
All 25 EU states are devoting more resources to REA, which helps to identify the most valuable medicines, both in terms of clinical efficacy and cost-effectiveness, and to set a fair price for them, EU Health Commissioner Markos Kyprianou told the Forum. He called for EU-wide procedures to be put in place speedily to share best practices and help improve REA accuracy.
However, before the meeting, one Member of the European Parliament suggested that the member states would block any changes to REA in order to keep costs down. They would also seek to avoid any changes in pricing and information because they want to retain control in these areas, said German MEP Jorgo Chatzimarkakis.
He suggested that a common EU body should be set up to conduct REAs, or for various national bodies to specialize in different drugs; for example; the UK's National Institute for Health and Clinical Excellence could concentrate on the cost-effectiveness of drugs for cardiovascular diseases, while Germany's IQWIG would focus on new diabetes drugs.
Dr Chatzimarkakis also attacked current European pricing policies, stating that in no other market do states decide prices as they do for the pharmaceutical industry. It was "totally illogical" that new medicines are forced on to the market at low prices while blockbuster drugs have high prices, he said, adding: "the system does not work - firms and industry are leaving Europe because of these market barriers."
Also ahead of the meeting, the European Federation of Pharmaceutical Industries and Associations had stressed the need for the Forum to find the right balance between rewarding innovation, providing patient access to medicines and managing costs of social security systems in Europe. After the discussions, a spokesman for the industry group expressed disappointment to PharmaTimes that more progress had not been made.
The next meeting of the Pharmaceutical Forum is scheduled to be held in June 2007.
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