The Janssen Way and Legitimate Interest

What is the “Janssen Way"?

At Janssen, our core responsibility is to develop innovative treatments for unmet medical needs and delivering great outcomes to patients and society. To strengthen our efforts, we collaborate with many other groups and organisations who share the same goal. With our pharmaceutical expertise, we play a vital role in advancing medicine, through research and development of new treatments, as well as ongoing education and continued safety monitoring. Collaboration, mutual trust and respect are essential for bringing value to both patients and society.

At Janssen, we work in trusted partnerships with patient organisations, and healthcare professionals to help transform lives and reinvent healthcare. Since the 13th of January 2020, Janssen Sciences Ireland UC have introduced a 'legitimate interest' model to disclose any payments made to healthcare professionals (HCPs), and healthcare organisations (HCOs) with whom we work.

Legitimate Interest

Our collaboration with Healthcare Professionals (HCPs) – The Janssen Way

The way we collaborate with HCPs is governed first by law and further by industry standards set out by the Irish Pharmaceutical Healthcare Association (IPHA) code of practice. In addition, Janssen has its own ethical business principles for our collaboration with HCPs, “The Janssen Way”. Integrity in working with the medical community and HCPs

• The integrity of the decision of a HCP to prescribe or recommend a medicine is one of the pillars of the healthcare system. We recognise that interactions between pharmaceutical companies and HCPs can create the potential for conflicts of interest and we take care to ensure their professional integrity is never compromised.
• Our internal principles are strict and govern our interactions with HCPs and Healthcare organisations (HCOs), in line with all existing regulations and our ethical approach. Our internal processes, underpinned by the values enshrined in our company Credo include comprehensive training for all employees, standardised systems for the review and approval of transactions, ongoing monitoring and audits.

Collaboration between partners in healthcare involving Transfer of Value (ToV)

Janssen is publicly disclosing any Transfers of Value (ToV) Janssen has made to HCPs and HCOs as required by the IPHA Code.

The ToV’s to be disclosed can be categorised into three key areas:

1. Supporting educational programmes
2. Fee for services (FFS)
3. Research & Development ToV related to the planning and conducting of studies.

1. Supporting educational programmes

Janssen sponsors and supports where possible Continuous Professional Development (CPD) programmes (i.e. congresses, educational meetings, etc.) in order to further educate HCPs about new treatment approaches, and in doing so, enhance their knowledge for the benefit of their patients.

We aim to provide fair and balanced education programmes that follow guidelines defined by accrediting bodies in Europe; these are based on the medical community’s educational needs and are carried out by independent expert committees.

At Janssen, our support of educational programmes is regulated and transparent:

• Making financial contributions in the form of grants and sponsorships to support educational activities and congresses organised by respected medical societies and other scientific third parties on local, European and international basis.
• Developing medical educational programmes, which are organised with independent experts according to strict Janssen guidelines.
• Supporting individual doctors to attend congresses and educational meetings based on their educational needs or active involvement.

Logistical arrangements for these activities follow Irish Pharmaceutical Healthcare Association (IPHA) guidelines, are always modest and strictly limited to the HCPs and to the main purpose of the event.

2. Fee-for-service (FFS)

• HCPs and HCOs provide Janssen with independent and expert knowledge derived from their clinical and management experience and Janssen compensates them fairly for the services provided.

• Janssen pays fair market value based on the time required by a HCP to deliver a service (hourly rates are defined independently on a country basis). Janssen respects the autonomy of HCPs and will ensure its activities observe all ethical business practice standards to avoid conflicts of interest.

3. R&D ToV related to the planning and conducting of studies

• Clinical trials are a key requirement in the development of medicines, which require the involvement of clinicians and their patients.

• We compensate relevant clinicians and hospitals fairly for their time, expertise and resources required to undertake this necessary research.

• Transparency in clinical trial data: As a company, we believe that greater clinical trial data-sharing for the advancement of science and medicine is the right thing to do. This is demonstrated by our agreement with Yale University Open Data Access Project (YODA) to enable access to our clinical trial data. It is the first time any company has collaborated with a completely independent academic third party to review and make final decisions regarding every request for clinical data. For further information, please visit http://yoda.yale.edu/johnson-johnson.

CP-229344 | April 2021