The research-based pharmaceutical industry is the primary source of information about its own products and recognizes its responsibility for ensuring product information is accurate and does not mislead. Advertising and promotion are an essential for informing healthcare professionals about new medicines and new uses for existing medicines. Self-regulation, via the IRPMA Code of Practice sets standards for the ethical promotion of medicines.
This self-regulation is setting highest standards for the ethical promotion of medicines, in accordance with Taiwanese regulations and internationally defined standards of good practice. As part of its commitment to health, the industry has an obligation and responsibility to provide accurate information about its products to healthcare providers, in order to establish a clear understanding of the appropriate uses of each prescription medicine. According to our self-regulating regulations, all marketing practices must be consistent with high ethical standards and information should be designed to help healthcare providers to improve the services provided to patients. Information provided must be objective, truthful and in good taste.
IRPMA Guiding Principles on Ethical Conduct and Promotion
The International Research-based Pharmaceutical Manufacturers Association (IRPMA) member companies engage in medical and biopharmaceutical research in order to benefit patients and support high-quality patient care. Pharmaceutical companies, represented by IRPMA, promote, sell and distribute their products in an ethical manner and in accordance with all the rules and regulations for medicines and healthcare.
The following Guiding Principles set out basic standards to inform the 2012 IRPMA Code of Practice which applies to the conduct of IRPMA Member Companies and their agents. This helps ensure that their interactions with stakeholders are appropriate.
- The healthcare and well-being of patients are the first priority for pharmaceutical companies.
- Pharmaceutical companies will conform to high standards of quality, safety and efficacy as determined by regulatory authorities.
- Pharmaceutical companies’ interactions with stakeholders must at all times be ethical, appropriate and professional. Nothing should be offered or provided by a company in a manner or on conditions that would have an inappropriate influence.
- Pharmaceutical companies are responsible for providing accurate, balanced, and scientifically valid data on products.
- Promotion must be ethical, accurate, balanced and must not be misleading. Information in promotional materials must support proper assessment of the risks and benefits of the product and its appropriate use.
- Pharmaceutical companies will respect the privacy and personal information of patients.
- All clinical trials and scientific research sponsored or supported by companies will be conducted with the intent to develop knowledge that will benefit patients and advance science and medicine. Pharmaceutical companies are committed to the transparency of industry sponsored clinical trials in patients.
- Pharmaceutical companies should adhere to both the spirit and the letter of applicable industry codes. To achieve this, pharmaceutical companies will ensure that all relevant personnel are appropriately trained.
- The ethical promotion of prescription medicines is vital to the pharmaceutical industry’s mission of helping patients by discovering, developing and promoting new medicines. Ethical promotion helps to ensure that healthcare professionals globally have access to information they need, that patients have access to the medicines they need and that medicines are prescribed and used in a manner that provides the maximum healthcare benefit to patients.
- The IRPMA is a non-profit, non-governmental organization comprising European, American, Japanese, and Taiwanese research-based pharmaceutical companies. Member companies and distributors, commissioned agents or representatives acting on behalf of any IRPMA member company, are committed to the ethical standards set out in this Code.
- The IRPMA Code of Practice (the “IRPMA Code”) based on the IFPMA Code of Practice 2012 version includes standards for the ethical promotion of pharmaceutical products to healthcare professionals, and helps ensure that member companies’ interactions with healthcare professionals and other stakeholders, such as medical institutions and patient organizations, are appropriate and perceived as such.
- The IRPMA Code is consistent with local laws and regulations.
- IRPMA member companies are accountable for addressing and correcting infringements under relevant codes. They should also ensure that internal structures and procedures (including adequate training of employees) are created to ensure responsible and ethical promotional activities. Companies not in membership with IRPMA may elect to be subject to the IRPMA Code and its complaints handling processes.
- The IRPMA is open to receive genuine complaints from any source on any aspect of the IRPMA Code, in accordance with its operating procedures. Where it is determined that there has been a breach of the IRPMA Code, the objective is to correct the matter as rapidly as possible.
- Effective 1st September 2012, the IRPMA Code of Practice (Updated 2012) replaces the 2007 IRPMA Code of Marketing Practices. Member companies of IRPMA must incorporate this Code into existing internal codes no later than 1st September 2012.