Starting or Strengthening a Drug Bulletin - A Practical Manual
(2005; 165 pages) View the PDF document
Table of Contents
View the documentPreface
View the documentHow the manual was produced
View the documentAbout ISDB
View the documentExecutive summary
Open this folder and view contents1. Introduction
Open this folder and view contents2. Rational use of medicines
Open this folder and view contents3. What are drug bulletins?
Open this folder and view contents4. Defining aims, target and type of bulletin
Open this folder and view contents5. Planning resources
Open this folder and view contents6. Planning bulletin production: schedules and timing
Open this folder and view contents7. The editorial process
Open this folder and view contents8. Reviewing a new drug: is it a therapeutic advance?
Open this folder and view contentsAnnexe to Chapter 8: Evaluating harm
Open this folder and view contents9. Design and production
Open this folder and view contents10. Dissemination
Close this folder11. Organizational and legal issues
View the document11.1 Introduction
View the document11.2 Why does a drug bulletin need a structure?
Open this folder and view contents11.3 Different kind of structures
View the document11.4 How to deal with legal action
Open this folder and view contents11.5 Copyright
View the document11.6 Further reading
Open this folder and view contents12. Evaluating quality and usefulness
Open this folder and view contents13. Partnership and collaboration
Open this folder and view contents14. Keeping records and creating a memory
Open this folder and view contentsAppendix: Electronic sources of information
 

11.4 How to deal with legal action

The first rule in dealing with legal action is to avoid it. A bulletin should make sure that the information published is correct, carefully worded, based on reliable sources and that the conclusions can be defended. Appropriate editorial processes, quality control and peer review procedures help to ensure the accuracy of the information that is published (see Chapters 7 and 9). Some bulletins routinely ask a legal adviser to check the content before publication.

Even if the published information is accurate a bulletin may still encounter pressure from others, such as pharmaceutical firms that are not pleased with what is written about their product. These pressures sometimes include legal threats, but in practice legal action from the pharmaceutical industry against ISDB member bulletins has been rare.

Although legal action is rarely taken against a drug bulletin, if a firm objects to an article (or the draft of a proposed article), they may well send a letter signed by their legal department or by an independent lawyer threatening to take legal action if the piece is not amended or withdrawn. As a rule this is little more than sabre-rattling. Ask your own lawyer to look at it, but don’t be afraid of empty threats. It may be sensible to modify words that have given particular offence, but if you have told the truth and told it well there will be very little risk of legal action. In some countries, including the USA, under some circumstances there is no liability for good faith publication of even a defamatory falsehood, although the truth is the “perfect defence” to a lawsuit for defamation (i.e. the legal doctrine that allows a person to sue in court and recover damages from someone making false statements that harm the plaintiff's reputation). Each country may have different legal rules.

Box 11.1 Legal aspects of electronic publication

As more and more human conduct appears online, questions often arise concerning whether and how to apply to the Internet the legal principles developed for the offline world. What rules apply when allegedly defamatory statements are made online? Generally, allegedly libellous (i.e. written) statements made online are usually evaluated by the same standards as statements made offline, with some countries adopting by legislation special rules defining the liability of various online service providers. A legal expert should be consulted.

In case of legal threats or strong objections to the content of your bulletin by a pharmaceutical company, it may be helpful to offer to meet with company representatives at your office. This may help to settle the criticism. Some bulletins offer the pharmaceutical industry an opportunity to comment on the text before publication. This can be done as part of the review process. It may however lead to unnecessary delays in publication and extra work for the editors when a company is dissatisfied with the content of an article. If you publish letters to the editor in your bulletin, this may be a better place to deal with criticism and comments from companies.

Box 11.2 Disclaimers

Some publications contain a ‘disclaimer’ in every issue in order to avert legal action. The following text is from Meyler’s Side Effects of Drugs:

“No responsibility is assumed by the Publisher for any injury and/or damage to persons or property as a matter of product liability, negligence or otherwise, or from any use or operation of any methods, products, instructions or ideas contained in the material herein. Because of the rapid advances in the medical sciences, the Publisher recommends that independent verification of diagnoses and drug dosages should be made.”

The legal value of a disclaimer is dubious. A law court may well feel that it is rather like a company trying to escape from giving a guarantee, but having a disclaimer may keep the publisher happy.

Many drug bulletins receive letters from companies (or from opinion leaders defending companies that pay them) complaining about the content of an article. Most bulletins deal with such complaints by responding to the company or the opinion leader directly. Take time to respond to threatening letters, and make sure you have had a chance to calm down before drafting a reply. Certain bulletins deal with complaints by publishing the complaint and a reply in their ‘letters to the editor’ section and/or on their web site to make the whole exchange visible. There are important advantages to publishing the letter and the editor’s response in the bulletin. The bulletin shows that it takes criticism seriously and it will be more difficult for the company to publicise their criticism - for example, through sales representatives - without taking the response of the bulletin into account.

Should your bulletin come under pressure do not hesitate to ask for help from other bulletins. It may help to contact ISDB or individual drug bulletins in other countries to ask for support, for example, by confirming certain scientific statements in case of a disagreement on the content of an article. The simple fact that it is becoming known internationally that a third party is pressuring your bulletin may ward off the pressure as verified on several occasions by member bulletins.

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