Våra åtaganden


Våra åtaganden är en samling interna regler och riktlinjer som bildar den övergripande struktur som skall vägleda Orexo i såväl beslutstagande som i den dagliga verksamheten. Tillsammans lägger de grunden för vårt förhållande till patienter, samhälle, aktieägare, samarbetspartners och övriga intressenter - inte minst våra medarbetare.

Orexo wants to be recognized for the value our pharmaceutical products brings to the patients and being trusted for the way we work and operate in delivering benefits to patients, society, partners and other stakeholders.

Orexo’s long term success is ensured by its employees’ and management’s engagement and strong commitment to quality as a given in every aspects of the daily work, keeping the patients of the pharmaceutical product in mind.

To assure patient safety and availability of high quality pharmaceutical products, fulfilling the medical needs and expectations of the patients, Orexo’s senior management is committed to maintain an effective corporate Quality Management System in compliance with applicable laws, regulations and internationally recognized standards.

Orexo’s senior management ensures the effective corporate Quality Management System through:

• Maintenance of processes and organization that clearly define individual and collective roles, responsibilities, authorities and inter-relationships of the organizational units and processes.

• Demonstrating visible support to the corporate Quality Management System, ensuring its implementation throughout their organizations.

• Communicate objectives, in which quality and compliance aspects are integrated, and provide adequate resources and competences to deliver these objectives.

• Periodically review the suitability and effectiveness of the Quality Management System and advocating its continual improvement.

 

Introduction to the Code

Orexo’s ambition is to be recognized for the added value our products bring to our patients and we want to be a trusted partner for the way we work and operate delivering benefits for patients, society, shareholders and other stakeholders. The Code is a critical document to set Business Compliance and Ethical standards for Orexo. The Code applies to all directors, officers, employees, consultants and temporary staff at Orexo AB and its subsidiaries (collectively referred to as “Employees”).

In the Code, Orexo embrace and support the Ten Principles of the UN Global Compact on Human Rights, Labor, Environment and Anti-corruption.

Application of the code

  • Management have the responsibility to ensure the Code, relevant supporting policies, standards, processes and procedures for Orexo are aligned with the laws and regulations in the countries in which Orexo operates and to provide assurance, support and guidance on compliance therewith.
  • Every Employee is required to understand and comply with the Code, all applicable supporting policies, standards, processes and procedures effective in the countries where the Employee is working or operating on behalf of Orexo.
  • Every Employee is expected to exercise good judgment and common sense in their doings to secure compliance with the Code, all applicable supporting policies, standards, processes and procedures, and must report any known, suspected or identified breaches thereof.
  • Failure to comply with the Code, relevant supporting policies, standards, processes and procedures or the laws and regulations of the countries where we operate will be investigated and appropriate actions taken, like additional training, disciplinary action including termination of employment or assignment.
  • In case of conflicts between internationally recognized standards and local legislation, Orexo shall manage such conflicts case by case, taking into account the risks and benefits for stakeholders and the general public.

Raise questions or report Non-Compliance

  • Every Employee are encouraged to ask questions if they are unsure of any content specified in the Code. Questions should be raised to the immediate manager – if so desired the Employee may pose questions directly to the HR or Compliance Officer.
  • Every Employee has a duty to report any suspected non-compliance or violation without delay to the immediate manager – if this is deemed inappropriate the Employee may report directly to the HR or Compliance Officer. 
  • Anyone who reports a possible non-compliance issue in good faith will be supported by management and will not be subject to retaliation or any threat of retaliation. Retaliation or threat of retaliation will be considered as a violation of this Code in itself.
  • Reporting of concern may also be made on the web or by letter, telephone or e-mail to:

Orexo AB

CEO´s Office, Attn: Compliance Officer
Box 303
751 05 UPPSALA
Sweden

E-mail: [email protected]

Orexo US, Inc.               

Tel: +1‐844-251-4251
Web: www.orexo.ethicspoint.com

Human Rights

Orexo recognize every individual’s human rights and is committed to meet its responsibilities to respect internationally recognized Human Rights standards, as described in the International Bill of Human Rights and according to the fundamental rights set out in the International Labour Organization’s Fundamental Principles and Rights at Work.

Orexo respect the personal integrity and values the personal data entrusted and is committed to collect, use, retain and disclosing personal data in a fair, transparent and secure way and according to applicable laws and regulations.

Orexo prioritize Human Rights within the supply of goods and services. Through the Supplier Code of Conduct, Orexo’s standards and expectations are declared for business partners and risk management is integral in due diligence activities when interacting with other businesses.

Labor and employment

Orexo is committed to a safe and healthy workplace for all our Employees and visitors. Every Employee is expected to identify and understand the risks associated with their work, manage risks responsibly and only perform work for which adequate training has been provided. Orexo condemn any form of harassment or discrimination including such characteristics protected by applicable laws and regulations.

Orexo will comply with local employment standards and regulations applicable in the various countries where Orexo has Employees. Orexo respects the principles and standards regarding child labor, forced labor, freedom of association and minimum wages laid out in the UN Declaration of Human Rights as well as by the International Labour Organization.

Environmental Care

Orexo is committed to continuously reducing the environmental impact of its operations by identifying improvements in all parts of the product life cycles and support waste and emission reduction and energy-saving initiatives. Orexo works jointly with business partners, stakeholders and authorities to foster a greater environmental responsibility and as a minimum adhere to local and international laws and regulations.

Prevention of corruption and conflict of interest

Orexo and its Employees shall adhere to the highest standards of moral and ethical conduct, to respect local and international recognized laws and regulations and not engage in any form of corrupt practices, including but not limited to extortion, fraud, or bribery.

No Employee may accept, offer or pay bribes or directly or indirectly accept gifts, hospitality, fringes or compensation in any form from a third party which may be unlawful or which could in any way affect his/her professional judgment in performing any duty or service for Orexo.

Employees may not engage in any activity that directly or indirectly compromises his or her independence or judgement, causing the interests of the employee or another person to inappropriately influence a decision, duty or service for Orexo or a third party.

Orexo does not allow direct or indirect engagement in, contributions or support to public policy or political activities, including governmental entity, political organization, party or candidate and policy advocacy organizations, on behalf of Orexo, except where ethically sound, permitted by law and where acceptable as part of local custom and practice, and approved under established company procedures.

It is particularly important to observe this with respect to national, local and international government officials, healthcare professionals and organizations, patients, suppliers and non-governmental organizations.

Research and Product Development

Orexo is engaged in developing innovative solutions for new pharmaceutical products and will apply high ethical standards in all research and product development activities globally complying with all applicable laws and regulations, the Declaration of Helsinki, and recognized international standards keeping the safety and wellbeing of the patients of the pharmaceutical product in mind.

Animal testing should only be performed after consideration to replace animals, to reduce the numbers of animals used, or to refine procedures to minimize distress. Alternatives should be used wherever these are scientifically valid and acceptable to regulators.

Patient Safety and Benefits

Orexo is committed to continue to monitor the safety and efficacy of our products on the market to identify any change to their benefit-risk balance, keeping the appropriate regulatory authorities informed hereof and co-operate with them in taking any necessary actions.

Orexo is committed to ensure that every stage of the manufacture and supply of the pharmaceutical products are conducted so as to ensure that they fulfil their quality requirements, are fit for their intended use and secure their availability to the patients.

Orexo is committed to applying the highest ethical standards when providing information about our products and such information shall be supported by scientific evidence, be accurate and not misleading and provide a fair balance about product benefits and risks.

Orexo also recognize and put efforts into preventing and combat the growing problem of counterfeit and illegally traded pharmaceutical products, which can adversely affect the health and wellbeing of millions of people worldwide.

 

INTRODUCTION TO THE SUPPLIER CODE OF CONDUCT

Orexo’s ambition is to be recognized for the added value our products bring to our patients and we want to be a trusted partner for the way we work and operate delivering benefits for patients, society, shareholders and other stakeholders.

In the effort to fulfil these ambitions, Orexo support the UN Global Compact and embrace the Ten Principles on Human Rights, Labour, Environment and Anti-corruption.

This Supplier Code of Conduct sets out Orexo’s ethical business expectations of our suppliers and business partners providing goods or services in areas of specific relevance to our business operation and interactions with third parties.

APPLICATION OF THE CODE

  • The expectations in this Suppliers Code of Conduct apply to Orexo’s suppliers and business partners, including the supplier’s or business partner’s sub-contractors, temporary staff and consultants (hereafter collectively referred to as a supplier) of goods or services for Orexo.
  • However, Orexo strongly encourage our suppliers and other business partners to expand their ethical business efforts, as described in this code, into the business processes and decisions in the supplier’s upstream supply chain management and procurement activities.
  • Orexo is committed to implement these Principles and strongly encourages our supply partners to adhere to them.
  • Orexo believes that society and business are best served by responsible business behaviors and practices. Fundamental to this belief is the understanding that a business must, at a minimum, operate in full compliance with all applicable laws, rules and regulations.
  • Orexo is aware of differences in culture and the challenges associated with interpreting and applying these Principles globally. While Orexo believe that what is expected is universal, it is understood that the methods for meeting these expectations may be different and must be consistent with the laws, values and cultural expectations of the different societies of the World.
  • Orexo believes the Principles are best implemented through a continual improvement approach that advances supplier performance over time.

ETHICS

Suppliers shall conduct their business in an ethical manner and act with integrity.

Business Integrity and Fair Competition

All corruption, extortion and embezzlement are prohibited. Suppliers shall not pay or accept bribes or participate in other illegal inducements in business or government relationships. Suppliers shall conduct their business consistent with fair and vigorous competition and in compliance with all applicable anti-trust laws. Suppliers shall employ fair business practices including accurate and truthful advertising.

Identification of Concerns

All employees should be encouraged to report concerns or illegal activities in the workplace without threat of reprisal, intimidation or harassment. Suppliers shall investigate and take corrective action if needed.

Research and Development

Research and development activities shall adopting high quality science and delivered consistent with all applicable laws and regulations, the Declaration of Helsinki, and recognised international standards to the proposed work in all countries in which they are conducted, keeping the safety and wellbeing of the patients and public health in mind.

Animal testing should only be performed after consideration to replace animals, to reduce the numbers of animals used, or to refine procedures to minimize distress. Alternatives should be used wherever these are scientifically valid and acceptable to regulators.

Information and Data Privacy

Suppliers shall protect and properly use confidential information and personal data to ensure that company, employees, and patient privacy rights are protected.

Suppliers recognizes Orexo’s commitment to work only with suppliers who operate its business in compliance with all applicable laws and regulations for the protection of personal data and individual’s right to privacy, including the General Data Protection Regulation of the European Union (GDPR) and the Health Insurance Portability and Accountability Act (HIPAA) in the United States.

LABOR

Suppliers shall be committed to uphold the human rights of employees and to treat them with dignity and respect and adhere to the Labor principles in the UN Declaration of Human Rights and the International Labour Organization Declaration on Fundamental Principles and Rights at Work.

Suppliers are expected to at least uphold the freedom of association and the effective recognition of the right to collective bargaining, the elimination of all forms of forced or compulsory labour, the effective abolition of child labor and the elimination of discrimination in respect of employment and occupation. Suppliers shall pay employees according to applicable wage laws, including minimum wages, overtime hours and mandated benefits and communicate with the employees the basis on which they are being compensated in a timely manner.

HEALTH AND SAFETY

Suppliers shall provide a safe and healthy working environment, including for any company provided living quarters.

Employee Protection

Suppliers shall protect employees from over exposure to chemical, biological, physical hazards and physically demanding tasks in the work place and in any company provided living quarters.

Process Safety

Suppliers shall have programs in place to prevent or mitigate harmful or catastrophic releases of chemicals.

Emergency Preparedness and Response

Suppliers shall identify and assess emergency situations in the workplace and any company provided living quarters, and to minimize their impact by implementing emergency plans and response procedures.

Hazard Information

Safety information relating to hazardous materials and equipment - including pharmaceutical compounds and pharmaceutical intermediate materials - shall be available to educate, train, and protect employees from hazards.

ENVIRONMENT

Suppliers shall operate in an environmentally responsible and efficient manner to minimize adverse impacts on the environment. Suppliers are encouraged to support a precautionary approach to environmental challenges, conserve natural resources, to avoid the use of hazardous materials where possible and to engage in activities that reuse, recycle and save energy.

Environmental Authorizations

Suppliers shall comply with all applicable environmental regulations. All required environmental permits, licenses, information registrations and restrictions shall be obtained and their operational and reporting requirements followed.

Waste and Emissions

Suppliers shall have systems in place to ensure the safe handling, movement, storage, recycling, reuse, or management of waste, air emissions and wastewater discharges. Any waste, wastewater or emissions with the potential to adversely impact public health and environment shall be appropriately managed, controlled and treated prior to release into the environment.

Spills and Releases

Suppliers shall have systems in place to prevent and mitigate accidental spills and releases to the Environment.

PRODUCT SECURITY AND SUPPLY CHAIN INTEGRITY

Suppliers are expected to tackle the threat of counterfeit and illegally traded medicines, as it applies to their business operation, and shall not be involved in any activity related to counterfeit or illegally traded medicines. Counterfeit medicines are those that are deliberately and fraudulently mislabeled with respect to identity and/or source. Illegally traded medicines include illegally diverted, fraudulently traded, tampered with and/or stolen medicines.

Supply Chain Integrity

Suppliers shall have systems in place and take the necessary steps to ensure the integrity, security and authenticity of the medicines through the end to end supply chain and to prevent illegally traded medicines.

Traceability, Diversion Prevention and Prevention of Counterfeit Medicines

Suppliers shall establish procedures and records to ensure traceability of medicines, and its active ingredients, as well as any waste, surplus, returned or discarded medicines, and its active ingredients, and including printed packaging materials and decommissioned machinery that introduces threats with respect to counterfeit and illegally traded medicines.

Identification of Concerns and Response

Suppliers shall inform Orexo in a timely manner in the event of any incident related to illegally traded or counterfeit medicines. Suppliers are expected to provide support in any subsequent investigation of such events or incidents.

MANAGEMENT SYSTEMS

Suppliers shall use management systems to facilitate continual improvement and compliance with the expectations of these principles.

Commitment and Accountability

Suppliers shall demonstrate commitment to the concepts described in this document by allocating appropriate resources, authorities and responsibilities.

Legal and Customer Requirements

Suppliers shall identify and comply with applicable laws, regulations, standards and relevant customer requirements.

Risk Management

Suppliers shall have mechanisms to determine and manage risks in all areas addressed by this document.

Documentation

Suppliers shall maintain documentation necessary to demonstrate conformance with these expectations and compliance with applicable regulations.

Training and Competency

Suppliers shall have a training program that achieves an appropriate level of knowledge, skills and abilities in management and employees to address these expectations.

Continual Improvement

Suppliers are expected to continually improve by setting performance objectives, executing implementation plans and taking necessary corrective actions for deficiencies identified by internal or external assessments, inspections, and management Reviews.