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The German government has initiated legislation--effective August 1--that puts the public interest ahead of the interest of the pharmaceutical industry by shifting the responsibility of proving the cause of an adverse drug effect from patients to drug manufacturers.
Each year it is estimated that 100,000 Americans die each year because of adverse drug reactions—the financial cost is $177 billion annually.
Source: According to the California Pharmacists Association, http://www.msnbc.com/news/691657.asp#BODY
These lethal side-effects are the result of inadequate research, poorly designed drug trials, and a speeded up drug approval process which is good for the drug business, but lethal for public health.
The German Justice Minister and Health Minister who introduced the legislation are quoted in Lancet: “The government’s objective is to strengthen the legal position of patients and to improve the enforcement of their rights.”
The U.S. government—FDA— on the other hand, has been complicit in helping drug manufacturers keep the known (to them) adverse drug effects secret. As a result thousands of preventable deaths occur annually, and victims have no recourse because they can’t prove the drug is the cause.
[See, AHRP most recent Infomail about ADRs, June 21, 2002: “Doctor Sounds Off” in Barron’s. Scott Gottlieb, MD, “The FDA’s reluctance to release data to the public can hurt patients ... and portfolios”
http://online.wsj.com/article_barrons_email/0,,SB1024093105950957600,00.html
Drug manufacturers will now have an incentive to disclose to German physicians and the public the potential side effects in drug package labels—or face an avalanche of lawsuits. Why does the American taxpayer deserve less?
ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)
http://www.researchprotection.org Contact: Vera Hassner Sharav 212-595-8974 e-mail: veracare@rcn.com
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New law in Germany compensates patients for drug side-effects The German government passed new legislation on Aug 1 that will make it easier for patients who have adverse drug reactions (ADRs) to get compensation from pharmaceutical companies.
The new law shifts the responsibility for an ADR back to the drug firms so that to receive compensation, patients no longer have to prove that a drug caused an unexpected side-effect. From now on the drug manufacturer, to avoid paying compensation, must prove that the adverse effect was not produced by its product.
“The government’s objective is to strengthen the legal position of patients and to improve the enforcement of their rights”, said Justice Minister Herta Däubler-Gmelin in the Bundestag, when introducing the new legislation alongside the Health Minister Ulla Schmidt. The new law is part of attempts to reform Germany’s liability and compensation laws. From January, 2003, the compensation limit will be raised from E500 000 to E600 000 for individuals and from E100-120 million for group claims.
To prove liability, patients must identify medical evidence proving that the drug can cause an ADR. To help potential claimants, the new law gives patients the right to make enquiries about adverse effects before starting legal action. The manufacturer and licensing agency will be obliged to respond with complete disclosure. The new law compensates patients for the cost of extra health care as a result of their illness. Another clause establishes the right to additional damages for pain and suffering even where negligence is not established.
Presently, such damages are only paid when the manufacturer is found to be negligent. The change was welcomed by judges’ and lawyers’ associations, but received a lukewarm reception from the drug industry. “We think there should be a mutual right of enquiry so that we could also get information about the claimant—for instance about previous illnesses or other medicines he or she may be taking . . . without this it will be difficult for us to defend ourselves”, said Dirk Bartram, from the German Association of Research-Based Pharmaceutical Companies.
“This legislation change is a step in the right direction”, said Sabine Düver, from the Federal Working Group of Patient Associations. “However the right of enquiry also means an extra burden at the very moment the patient is feeling unwell . . . patients need help and the legislation has nothing to say about this. We think the health insurance companies should support the patient. They are not legally obliged to do so and this should be the next step in patients’ rights legislation”, she added.
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