CODE

VALUES AND STANDARDS

‘Only if all partners can trust each other, we can jointly provide the best care to patients.’

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Integrity

As pharmaceutical companies, and particularly as developers of innovative medicines, we are important allies of doctors and patients in the fight against diseases. After all, we are the pharmaceutical companies that develop new resources to fight these diseases.

As members of the Association Innovative Medicines, we realise that we are partners in a broader alliance of healthcare professionals, institutions, patient organisations, insurers and government. Only if all partners can trust each other, we can jointly provide the best care to patients.

That trust begins with integrity of conduct. Hence, in this section, we describe the principles of our conduct. These principles are about responsibility, provision of information and fair dealings with healthcare professionals and the public. They are also about the way in which we have organised ourselves to consistently adhere to these principles.

The Platform on Transparency and Ethics has established a list of principles to which we are committed.

In order to specify the core value of integrity, we consider the following:

Our conduct is transparent, responsible and consistent with the interests of patients and public health in general. We are committed to the List of Guiding Principles Promoting Good Governance in the Pharmaceutical Sector of the Platform on Transparency and Ethics.

Explanation:
This Code provides for the standards of the List of Guiding Principles Promoting Good Governance in the Pharmaceutical Sector, dealing with amongst others responsible behavior, transparency of relationships, information, promotion and benefits or inducements.

We provide healthcare professionals with timely, qualitatively good and complete medical information for independent judgement.

Explanation:
The choice to prescribe a medicine should only be made by a qualified healthcare professional based on a professional assessment of the patient’s interests. We will therefore inform healthcare professionals objectively about the medicines we provide and do nothing to induce these persons or institutions to prescribe or dispense these medicine to patients other than for medical reasons. The healthcare professional must be able to make decisions on the basis of sound and complete information (see also Article 91, par. 3 Dutch Medicines Act and Article 5.2.2.4 Code of Conduct for Pharmaceutical Advertising CGR).

Our advertising of our medicines is therefore only aimed at ensuring that healthcare professionals are aware of their existence and have the information necessary to make a balanced decision in prescribing them to patients. The principles that our advertising satisfies are described in the Code of Conduct for Pharmaceutical Advertising (Gedragscode Geneesmiddelenreclame, CGR), with which our members comply.

We promote our interests based on relevant and reliable information

Explanation:
In lobbying activities, we provide fair and reliable information. Our (internal and external) Public Affairs associates are trusted partners in the public debate, who check their information for accuracy before disseminating it.

We do not compromise the professional independence, reliability or integrity of healthcare professionals. We refrain from undesired influencing of healthcare professionals, institutions, patient organisations, patients and other stakeholders in prescribing, dispensing or using medicines. We comply with the Code of Conduct for Pharmaceutical Advertising (CGR).

Explanation:
The standards with regard to responsible relationships and information provision have been further elaborated in the Code of Conduct for Pharmaceutical Advertising (CGR).

We have a scientific department that is under qualified leadership. This department reviews all our promotional materials and medical information to be provided for accuracy.

Explanation:
We guarantee that all of our promotional materials and advertising give a fair representation of the facts and do not make false promises concerning what can be expected of our medicines. Therefore, we have a scientific medical department, which is led by a qualified manager with medical expertise. This department reviews all promotional materials and advertising for appropriate scientific substantiation.

To ensure that all employees comply with existing legislation and self-regulation and with the additional integrity standards (including this Code) of the organisation, we have a compliance programme.

Explanation:
We are professional organisations with good internal processes that ensure that our employees are aware of existing legislation and self-regulation and other integrity standards (such as this Code) and adhere to it in our activities. We therefore have a healthcare compliance programme that meets the following characteristics:

a. It has the unconditional support of management, as evidenced in the description of the compliance governance and roles within the organisation;
b. It provides clarity to employees as to which practices are or are not permitted, how to monitor these and the sanctions imposed for violations;
c. A (risk) analysis is conducted periodically to identify integrity risks in the organisation;
d. Based on this analysis, an audit will be conducted within the organisation to ensure compliance with the integrity rules;
e. Employees are trained periodically in applying the relevant laws and the additional integrity rules (such as this Code) of the organisation;
f. Each employee signs an integrity declaration in which he/she commits to the integrity standards of the organisation.
g. A reporting protocol enables employees to report violations of integrity standards without personal consequences after which these are followed up.
h. Periodically, management checks whether the compliance programme is still up to date.

Transparency

Openness is an important condition for trust. With regard to our societal mandate as pharmaceutical companies, open and clear communication is needed on how the (societal) interests of those involved are taken into account.

We may be expected to be transparent about our studies conducted during the (further) development of medicinal products, as well as their results and our financial relationships with healthcare professionals and patient organisations.

Furthermore, we play a role in predictability of the availability and affordability of medicines in the Dutch market, as well as the expected healthcare outcomes. A core value for us is to contribute to this transparency and predictability.

In the interpretation of the core value transparency, we consider the following:

We are open about all information that impinges on patient safety, such as new information about side effects.

Explanation:
As pharmaceutical companies, we are responsible for monitoring the safety and quality of our medicines. We research and test our medicines for side effects. Medications that we are already marketing are closely monitored, and all reports of suspected adverse reactions are registered.
Reports of suspected adverse reactions or product complaints are closely investigated and promptly communicated to the authorities. Should information need to be provided to the public on the safety and quality of medicinal products, we shall do this in consultation with the authorities.

In their communications, our employees immediately disclose that they work for a pharmaceutical company.

Explanation:
Our employees and contractors are required to be recognised as such when meeting with other stakeholders. For example, in professional contacts through social media, employees should disclose that they work for, or act on behalf of, a pharmaceutical company.

We register our clinical studies initiated in the Netherlands in public trial registers.

Explanation:
Before we start a clinical study for a new medicine in the Netherlands, we register this in the Netherlands Trial Register and for international studies, in another public trial register. This register is completely public and searchable. It contains all clinical studies that will be or are being conducted in the Netherlands or that involve Dutch researchers. See also Article ‘Good clinical studies’.

If we collaborate with third parties in clinical research and provide remuneration for this, we prepare a contract with them in advance, taking into account the model agreement of the Dutch Clinical Research Foundation.

Explanation:
In many cases, we work with researchers from universities or other research institutions. In order to properly arrange in advance how this research is to be done and what happens to the results, we always prepare an agreement in which this is jointly established. For this, we take the model agreement of the Dutch Clinical Research Foundation into account. This foundation is a partnership of university medical centres, research organisations, pharmaceutical companies, medical ethics committees, patient organisations and the government.

We publish the results of the pharmaceutical research we are conducting or initiated for, regardless of the results.

Explanation:
Scientific research benefits from openness and publicly available outcomes. This allows researchers to build on each other’s results and align their research. It is important that not only positive results be shared but also the results of research that did not have a successful outcome, for example because it has not been able to confirm the action of a remedy. We are committed to disclosing the results of a study at all times, regardless of the outcome. This applies both to research we have conducted ourselves and to research that we have initiated and paid for, directly or indirectly. We record the research results in the available databases.

We report financial relationships with healthcare professionals, healthcare institutions and patient organisations in the Healthcare Transparency Register.

Explanation:
To provide insight into the reimbursements paid (according to the criteria of the Code of Conduct for Pharmaceutical Advertising), our members use the Healthcare Transparency Register. This central registry is publicly accessible. An overview of financial reimbursements among pharmaceutical companies, healthcare professionals, institutions and patient organisations is published annually. This data is rendered publicly accessible through the Healthcare Transparency Register.

We publish annually how much we have spent on research and development of (new) medicines in the Netherlands.

Explanation:
We report how much we paid in total for pharmaceutical research in the Netherlands. In this way, it is clear which pharmaceutical companies invest in finding new medicines or improving methods of treatment, and the extent of such investment The structure of this reporting has been prepared by the European Federation of Pharmaceutical Industries and Associations and has been documented in the EFPIA HCP/HCO Disclosure Code. This data is accessible via the Dutch Association Innovative Medicines website.

We are committed to harmonising the different registers that track the outcome of treatments.

Explanation:
After the introduction of a medicinal product, it still is important to record the results of the treatments. This contributes to deeper insight that is important in the further development of, and information concerning, the medicine. Central registers documenting the effects of medicines help in this. Currently, several registers are kept side by side. One central register or an automated link between these decentralised registers is missing at the moment. As an Association, we are committed to achieve this in collaboration with other stakeholders.

We support the government and other parties in making good predictions of pharmaceutical expenses.

Explanation:
Both for government and for insurance and healthcare organisations, it is important to be able to make a good prediction of pharmaceutical costs. It is important for the government to know how many patients use each medicinal product. It is also relevant to know for which new medicines and indications market expansion may be expected. We are well positioned to collect this information. As an Association, we work closely with the government and involved parties to increase insight into pharmaceutical expenditure.

We work with healthcare organisations, healthcare professionals, and healthcare insurers to ensure a fair and transparent purchasing process when purchasing medicines.

Explanation:
An open and honest purchasing process is in the best interests of the purchasing healthcare institutions and the insurers as well as the pharmaceutical companies themselves. A good process defines the conditions of purchase in advance. As an Association, we strive to improve the purchasing process by formulating together with healthcare insurers, healthcare institutions and other purchasing parties the basic principles for a prudent and clear purchasing procedure, thus ensuring a fair and transparent process.

Social responsibility

We wish to be honest and reliable partners for those with whom we deal directly and wish to have a role in society as a whole. This means, among other things, defending the interests of patients, contributing to the improvement of the environment, providing resources for social projects, and providing a safe and pleasant working environment for employees.

Corporate social responsibility is a broad concept which is interpreted in different ways. International standards exist (incorporated in the ISO 26000) which describe what should be understood under good governance, respect for human rights, provision of good working conditions, environmental responsibility, fair business practices, consumer interests and involvement in the development of the community.

As internationally operating pharmaceutical companies, we embrace and implement these international standards.

In order to implement the core value of Social Responsibility, we consider the following:

We have established and published a mission and policy vision with regard to social responsibility.

Explanation:
We have described our social responsibility as part of our company’s mission. We publish this mission and vision so that these are clear to everyone.

We are in constant dialogue with stakeholders on the interpretation of our social policies and the implementation of social activities.

Explanation:
Social accountability begins with knowing the stakeholders and conducting dialogue with them. This allows them to communicate their wishes and expectations to us, and we understand what is happening in society and how it values the role of the pharmaceutical companies.
In this, we focus on external stakeholders, such as our patients, scientific institutions, governments, suppliers and society as a whole, but also on internal stakeholders, such as employees and directors.

In the development of our policies and in the day-to-day implementation of these, we consider the interests of others who rely on us.

Explanation:
We know and recognise our role in society and behave accordingly. When making important decisions which impact internal or external stakeholders, we weigh their wishes and expectations and can explain how final decisions have been made.

We give account of the results of our corporate policies in our annual report or in specific social reports.

Explanation:
We periodically report on how our company’s actions affect people, the environment and the economy. In this way, it is clear how we have specifically interpreted our vision regarding social responsibility.

Our policy is aimed at a sustainable availability of medicines and to avoid shortages of medicines.

Explanation:
Many patients’ lives or quality of life are dependent on the medicines we produce. Ensuring that these medications are adequately available for patients is therefore crucial. That is why we work closely with distributors, pharmacies and healthcare institutions.
We monitor production and stocks constantly and accurately. If we foresee shortages due to manufacturing issues, we report this ahead of time to the Medicine Shortages and Defects Notification Centre. We also look at how to prevent future shortages.

We ensure an inspiring, motivating and safe working environment for our employees and our partners.

Explanation:
We ensure inspiring and innovative work. Pharmaceutical companies are practising good employer practice. Importantly, there is attention for personal development (training) and a safe working environment (preventing discrimination, bullying, sexual harassment, etc.). The establishment of an internal code, diversity policy, whistle-blower scheme, confidential adviser, or internal complaint system contributes to a responsible working environment.

We are committed to increasing the sustainability of the pharmaceutical sector. This is achieved by resource-efficient and circular use of raw materials, contributing to clean water, a healthy living environment and CO2 reduction.

Explanation:
In the sector’s packaging sustainability plan, we have formulated concrete objectives for 2022 with regard to prevention of wastage of medicines and for sustainable and circular sourcing of packaging. In addition, we are working together in the chain to prevent medicinal residues from reaching groundwater and surface water and how to reduce the risks of environmental damage with quality of healthcare being paramount. We are committed to contributing to these themes at a European/international level.

We safeguard a careful processing of sensitive personal data.

Explanation:
We collect, manage, protect and destroy personal data in accordance with applicable legislation (General Data Protection Regulation (GDPR)). We work with sensitive personal data (of patients, consumers, healthcare professionals) only in relation to the development and use of medicines and if necessary in connection with reported adverse events, medical or product complaints or requests for further information by those concerned.

We support projects with the goal improvement in the innovation of medicines or science and thereby in the quality of healthcare.

Explanation:
We support quality-improvement and innovative projects. In doing so, we ensure that this support does not lead to an obligation to prescribe, dispense or use particular medicines (in accordance with Article 6.5.3 CGR).

We participate in social projects and support good causes.

Explanation:
As pharmaceutical companies, we support numerous NGOs and other good causes whose activities are related to our core business, worldwide. In example in which we participate is the project caregiver-friendly organisation.

Quality

As pharmaceutical companies we aim at achieving a high quality of our products and services. Pharmaceutical research and development is subject to strict quality standards and requirements. The requirements set our products, production and services is guaranteed by quality systems. Once a medicine is marketed, we closely monitor its safety.

We continuously monitor the various aspects of quality provided and allocate sufficient resources to improve the product and the process. In addition, we work with supply-chain partners to counteract counterfeit medicines.

In order to contribute to the quality core value, we consider the following:

We set high requirements with respect to the quality of our products and services, and ensure that our employees are well informed about these.

Explanation:
The quality requirements with which our products and services have to comply are governed by legislation, international standards of practice, regulations and other arrangements. Achieving these requirements is documented in quality manuals and is controlled by internal and external audits.

We focus on the quality of our products and services in the best interests of the patient.

Explanation:
The safety and effectiveness of patients’ medicines are paramount for us. The proper deployment and use of medicines contribute to the optimal value of patient care. We strive for the right resource at the right time for the right patient. We endorse the principles of value-based healthcare (result–focussed care for the patient).

We involve patients and patient organisations in improving the quality of products and services.

Explanation:
Patients have and keep control over their own health. We provide education about diseases and the optimal treatment of these. In addition to providing information and education on disease states, medicines and use and treatment, we inventory what patients want and expect. Taking into account the integrity standards, we involve patients (organisations) in development, use and education.

We contribute to keeping professional organisations’ treatment guidelines up-to-date through the provision and availability of scientific data.

Explanation:
Professional organisations’ treatment guidelines continuously evolve through research and renewed knowledge and insights. In collaboration with professional organisations of physicians, pharmacists, healthcare professionals and patient organisations, we provide scientific data for updating treatment guidelines.

Our pharmaceutical research is based on international standards.

Explanation:
Pharmaceutical research is internationally regulated, as in the European Legislation on Clinical Research and the Declaration of Helsinki. We comply with national legislation and regulations. In the design, conduct and reporting of clinical research, we adhere to the rules of Good Clinical Practices and for non-clinical studies, the Good Laboratory Practices. For NWMO studies (research not covered by the Wet Medisch-wetenschappelijk onderzoek met mensen [Medical Research involving Human Subjects Act]), we take the guidelines and agreements of the Dutch Clinical Trial Foundation into account. See also Article ‘Clinical studies’.

We produce our medicines according to Good Manufacturing Practices and under the control of a qualified person who fulfils the legal requirements governing training and work experience.

Explanation:
Medicinal products must be manufactured from raw material to finished product in accordance with the norms of international standards (Good Manufacturing Practices), under the responsibility of a Qualified Person. This forms part of the manufacturing licence and is audited by the authorities. Even if production takes place outside the EU, a screening – based on the same norms and standards – must be carried out by the authorities of one of the member states of the European Union.

We distribute our products according to Good Distribution Practices.

Explanation:
The distribution of medicinal products must, throughout the distribution chain, be in accordance with the Good Distribution Practices. Good Distribution Practices form part of the terms of a manufacturing licence and wholesale licence and ensure, amongst other things, the quality of storage, transport and destruction.

We control the use of our medicines by closely monitoring and following up reports and complaints about them.

Explanation:
We take responsibility for the quality, safety and efficacy of our products. That is why we carefully monitor our products and follow up on reports on the effects of our products in collaboration with the authorities. We follow the Good Pharmacovigilance Practices.

Complaints, suggestions and reports are recorded and resolutely pursued, and a reaction is given.

Explanation:
Complaints from customers and other stakeholders are taken and treated seriously. Complaints are recorded and analysed, and provide input for improvements. Our companies have a procedure to record complaints.

We support programmes for the good use of medicines. We promote compliance and combat counterfeiting.

Explanation:
As an Association, we participate, along with other healthcare parties, in the ZonMw-initiated Good Use of Medicines programme. This initiative encourages the addressing of questions concerning, for example, compliance. This involves research, practical projects, presentations, congresses and bringing together relevant parties. In addition, we contribute to good use of medicines by (further) developing diagnostic methods that support healthcare professionals in the treatment. Furthermore, we participate in the NMVO (Stichting Nederlandse Medicijnen Verificatie Organisatie [Netherlands Medicines Verification Organisation Foundation]), in which, in cooperation with other parties (KNMP, Bogin, BG Pharma), is worked on a comprehensive chain approach that can be used to ensure that patients receive only genuine highquality medicines.

We invest in professional operations and continuously monitor progress and achievement of our goals.

Explanation:
We have translated our objectives into KPIs and standards and our Management Information Systems provides insight into progress and results with regard to these KPIs. This insight enables us to respond adequately to (unexpected and unforeseen) developments and to adapt and improve business operations. In this way, we ensure the continuity of the organisation.

We continue to invest in improving and innovating treatments with our products, processes and services.

Explanation:
Responsibilities for implementing improvements are documented and known to us. Results of improvements are measured and communicated in the organisation.

CODE

VALUES AND STANDARDS

Integrity

Responsible conduct

Responsible information provision

Fair lobby

Responsible relationships

Scientific department

Compliance programme

Transparency

Safety information

Recognisability

Clinical studies

Clinical research collaboration

Publication of research results

Financial relationships

R&D expenditure

Harmonisation of registers

Government spending predictability

Procurement procedures

Social responsibility

Mission and vision

Social dialogue

Social interests

Accountability

Availability of medicines

Working conditions

Environment

Privacy

Support

Participation and charitable causes

Quality

Requirements

Patient central

Patient(organisation) involvement

Treatment guidelines

Good Clinical Practices

Good Manufacturing Practice

Good Distribution Practices

Good Pharmacovigilance Practices

Complaints

Good use

Monitoring results

Improvement