Johnson & Johnson (J&J) companies are known worldwide for the values that are observed in the development of innovative, and often life-saving medicines for patients. Our Credo, the J&J Policy on Business Conduct and the J&J Health Care Business Integrity Guide emphasize our commitment that our patients come first, and that everything we do is consistent with the laws and regulations in the different countries/markets in which we operate.
In their work, researchers respect the J&J Code for the Conduct of Research & Development, in which ethical considerations on strategy, planning and processes are the central focus. More specifically, this relates to:
- thorough knowledge of the bio-ethical principles in Research & Development (R&D);
- consistent responses to ethical dilemmas and challenges;
- a clear R&D policy;
- defense of the bio-ethical code within R&D;
- necessary transparency for all parties involved in R&D;
- guarantee that we can keep up with the increasing government inspections.
Janssen launched the Discovery Data Integrity (DDI) project as a means of supporting the integrity and the traceability of the Research & Development (R&D) research data. No statutory quality standards currently exist for these types of early data. Janssen purposefully aims to set the bar high, so that only the best products can pass from the research environment to the development phase.
The first step in this project was an analysis (baseline) of the quality level of the current research data as well as the completion of a required training course for all researchers. Excellent practices as well as opportunities for improvement were identified.
After this initial step, global project teams were set up to address the most important points of interest. Sustainable solutions were then considered, taking into account the solutions' workability and their time impact on the researchers being kept to a minimum.
As a result, the company is implementing an interactive campaign emphasizing the crucial importance of high-quality research data. Janssen is also making global agreements to safeguard and report data as transparently and securely as possible and is taking measures to support researchers with the best possible systems and complementary expertise.
The Global Quality Organization provides continuing support for the research itself and regularly performs random checks of research data. This is done to ensure that quality is measured on a continuing basis and to then adjust if necessary. After comparing the first set of randomly checked data with the baseline, it is clear that noticeable progress has already been made. With the DDI program, Janssen is developing maximum efficiency and a flexible research environment, which is sure to produce reliable, high-quality research data.
In clinical research, the efficacy and safety of a medicine is studied in humans before the medicine is brought onto the market. The clinical research into medicines must be in compliance with all existing guidelines and legislation. The government will not accept any evidence resulting from research that has not been conducted according to such guidelines and legislation. In this case, the drug will not be admitted onto the market or be registered.
These guidelines imply that research into medicines must be carried out according to Good Clinical Practice (GCP). In this way the interests of the test subject are defended (including safety and stress). This also ensures that the research provides reliable data. Several bodies, which vary from country to country, carry out inspections to ensure that the research is indeed conducted according to the legal regulations and directives. Inspections can also be carried out while the research is in progress, the so-called audits.
An audit is an inspection by an official body (either announced or unexpected) that is not involved in the research. This may, for example, be the Federal Agency for Medicines and Health Products (FAMHP) in Belgium, the Quality Assurance department of the company that has commissioned the study, or officials from the U.S. where the parent company J&J is established. An audit can take place in any research center, but also at the office where the data is collected and analyzed.
The purpose of an audit is to check whether the research is being conducted according to the protocol and the (legal) regulations. This ensures that the clinical research is objective and reliable, and that the test persons are protected. The auditor observes how the data is recorded, analyzed and reported.
For a long time now, one of Janssen's priorities has been to utilize the highest of standards in its contacts with care providers and governments. Our Credo and the J&J Policy on Business Conduct form the basis of this tradition. For seventy years now, this ethical company code has been a fundamental part of the way in which this company does business. The company wants to be able, at any moment, to guarantee that it deserves the trust of the patients, therefore it adheres to a Health Care Business Integrity (HCBI) policy. This policy sets out clear standards and regulations with which all Janssen employees who come into contact with care providers and governments must adhere.
The policy bundles all of the regulations related to the support of the research, advisory services for doctors, medical training, doctor's visits, company visits, communication, gifts, research conferences and scientific events—not only to be able to continue striving for transparency but also to comply with all kinds of statutory rules and regulations.
The Health Care Business Integrity (HCBI) Guide focuses on:
- the legal promotion of regulated products;
- compliance with the healthcare provision and anti-corruption legislation, regulations and industrial codes;
- no influencing of medical and governmental decisions on the basis of incorrect, incomplete or unclear information.
All employees who come into contact with professional care providers in the healthcare sector and with government employees receive specific training for these activities.