"The Chinese Government's vision and commitment to significantly improve the welfare of the Chinese people are articulated in the healthcare reform policy and the recently issued National 12th 5-Year Plan." "Concurrently, it is imperative that all stakeholders, including the pharmaceutical industry itself, reinforce the Government's commitment by adhering to the highest standards of professional and ethical conduct." Chairman's Message - (R&D-Based Pharmaceutical Association Committee, 2012 RDPAC Code of Practice)
The R&D-Based Pharmaceutical Association Committee ("RDPAC") of the China Association of Enterprises with Foreign Investment ("CAEFI") has revised and promulgated the RDPAC Code of Practice 2012 ("2012 Version") after a review of patient and stakeholder feedback. The 2012 Version came into effect on July 1, 2012, immediately replacing the FRPIA Code of Pharmaceutical Marketing Practice (2nd Edition, 2002), and the RDPAC Code of Practice on the Promotion of Pharmaceutical Products (2006) and (2010). Compared to the Code of Practice on the Promotion of Pharmaceutical Products (2010 Revision) ("2010 Version"), RDPAC has noted that the 2012 Version is a significant step forward which clarifies what is and is not acceptable, as articulated in twelve articles.
All Versions of the Code of Practice on the Promotion of Pharmaceutical Products are stipulated by the RDPAC of the CAEFI, which apply to all RDPAC member companies. As there is currently no specific law or regulation regarding the promotion of pharmaceutical products, all Versions of the Code of Practice on the Promotion of Pharmaceutical Products can be applied as a standard of moral behavior in the pharmaceutical sector. All Versions, however, are only binding on RDPAC member companies. To date, RDPAC has 39 member companies, consisting primarily of large foreign invested pharmaceutical enterprises, e.g. Pfizer, Bayer, GlaxoSmithKline, Novartis and Takeda, etc.
The 2012 Version has made some obvious revisions from the 2010 Version. For ease of reference, only significant changes to the 2010 Version as reflected in the 2012 Version are outlined here.
First, the 2012 Version has narrowed the scope of the definition of "member company". The 2012 Version defines "member company" as any R&D-based pharmaceutical company lawfully established or incorporated outside of China with substantial investment or operational interests in China that became a member of RDPAC, including foreign-invested enterprises or other legal entities registered in China by the overseas R&D-based pharmaceutical company. The 2012 Version is stricter than the 2010 Version, which merely defined "member company" as "a member of the RDPAC registered in accordance with official procedures".
Second, the 2012 Version has changed the scope of its application by 1) expanding the applicable scope under the Code of Practice, in particular including all member companies and their employees, including subcontractors that carry out tasks on behalf of the company, such as consultants, contracted sales representatives or PR agents; 2) changing the scope of the exclusions to the Code of Practice, namely, stipulating that the Code of Practice does not apply to the "Promotion of Medical Devices", but applies to the "the Conduct of Clinical Trials"; and 3) narrowing the scope of the person to whom a sample can be provided from "healthcare professionals" to "healthcare professionals authorized to prescribe that product". Under this more narrow scope, not all healthcare professional are entitled to obtain samples from member companies.
Third, the 2012 Version adds certain provisions regarding special use of pharmaceuticals. For instance, generally the communication of relevant information shall not be dispensed before the relevant pharmaceutical is released for sale. However, the 2012 Version provides an exception to this rule by not prohibiting such pre-approval promotion on the condition of compassionate use through charity programs, given that they comply with all applicable laws, regulations and administrative rules. However, member companies should ensure that communications for a compassionate use program are not, in effect, advertisements for an unlicensed drug or unlicensed use of a drug. This is the first time compassionate use is stipulated in the Code of Practice.
Fourth, the 2012 Version has grouped certain relevant information into special sections. For example, with regard to clinical trials, the 2012 Version has summarized and combined the 2010 Version content regarding clinical evaluation and other relevant information into a new and separate provision under "Article 9 Clinical Research and Transparency". It has further stipulated that conduct of clinical trials shall be governed by the 2012 Version and the publication of the information regarding the clinical trials shall be in accordance with the Joint Position on the Disclosure of Clinical Trial Information via Clinical Trial Registries and Databases (2009) and the Joint Position on the Publication of Clinical Trial Results in the Scientific Literature (2010) issued by the IFPMA, the European Federation of Pharmaceutical Industries and Associations (EFPIA), the Japanese Pharmaceutical Manufacturers Association (JPMA) and the Pharmaceutical Research and Manufacturers of America (PhRMA). This is the first time the Code of Practice has required the publication of the data and results of the clinical trials. The 2012 Version has also deleted the rules regarding medical representatives; the reason may be that the relevant laws and regulations for medical representatives are currently being drafted and under discussion.
The 2012 Version changed a numbers of details of how member companies and healthcare professionals are to communicate, including:
- Generally prohibiting the organization or sponsorship of exchange-related activities/events outside China and the provision or payment of entertainment.
No company may organize or sponsor an activity for healthcare professionals that takes place outside of their home country unless it is appropriate and justified from a logistical or security point of view (e.g., international scientific meetings and symposia that involve participants from many countries are justified and permitted). In addition, companies are not allowed to provide entertainment, leisure and social activities to healthcare professionals and other stakeholders, such as providing concert tickets, purchasing of other entertainment tickets or paying for entertainment in any form. However, refreshments and/or meals incidental to the primary purpose of the event, background music or local performances at the venue where the event is taking place, may be permitted if they are not paid for by a pharmaceutical company.
- Specifying service charges and conditions, and easing limits on the scope of hospitality.
The conditions of how member companies shall pay healthcare professionals are set out in the form of a "service fee". For example, a member company shall sign a written agreement regarding the services with the healthcare professionals; there must be a legitimate need for the services; healthcare professionals shall bear necessary qualifications; the number of professionals must be reasonable; and an inducement is prohibited and the service fee shall be reasonable and fair. Rules regarding accommodations and catering in the 2010 Version have been deleted; instead a general regulation is set out in that the hospitality provided must not exceed what participants would normally be prepared to pay for themselves.
- Additional conditions for the engagement of certain activities.
The conditions for the provision of promotional aids by member companies to healthcare professionals are now set out in three conditions, namely, "minimal value", "minimal quantity" and "relevant to the healthcare practice" compared to the use of two conditions ("minimal quantity" and "relevant to the healthcare practice") as were set out in the 2010 Version. Moreover, in the 2010 Version, any sponsorship provided to individual healthcare professionals must not be conditioned upon an obligation to "prescribe", "recommend" or "promote" any pharmaceutical products. The 2012 Version adds three more to the list, namely that the "purchase", "supply", and "administer[ing of]" any pharmaceutical products shall also not be considered as conditions to sponsorship.
In conclusion, the 2012 Version has further clarified promotional activities of pharmaceuticals, and has deleted some provisions while adding provisions that are more consistent and in compliance with current developments in the industry. It also provides a direction for the development of the promotion of pharmaceuticals in relation to healthcare professionals and other medical personnel. Subject to the self-governing of the industry, the 2012 Version will provide stricter moral restrictions and a more definite industry direction for the promotion of pharmaceutical products of member companies.