What responsibility means to us...

We work in a business where patients’ lives are at stake, so we seek to apply the highest ethical standards in all we do. This is core to our ‘Brave’ values and culture. It means ensuring that we have the right policies and procedures in place, and also making sure that our managers understand how to foster an ethical, responsible culture. Our Code of ethics, adopted by our Board of Directors, summarizes the standards and expectations that guide our actions. This code is compulsory reading for all employees, and we expect full compliance with its principles and spirit. Our code is based on the following:

• Respect the rule of law of the country within which we operate;
• Promise only what we expect to deliver, make only commitments we intend to keep, not knowingly mislead others and not participate in or condone corrupt or unacceptable business practices;
• Help provide education for patient advocacy groups and health professionals about the diseases in which we specialize;
• Respect the privacy rights of our customers, whether patients or health professionals;
• Provide products consistently that are safe for their intended use; and
• Not give or receive bribes in order to retain or bestow business or financial advantages.
• We encourage our employees to speak up if they have concerns about unethical workplace behavior or violations of policies and procedures, and operate a 24 hour a day, 7 day a week global helpline.

Ethical Marketing, Selling & Professional Support

Shire is a company that focuses its scientific and commercial efforts toward the specialty physicians . By design, our model allows the efficient use of resources to bring value to physicians, patients and caregivers through distinctive medicines and effective education programs. We organize our work around select therapeutic areas and identify, develop and register promising drug compounds to treat disease.

We focus on meeting the needs of the specialist physician and strive to develop strong, open and transparent relationships with them, patient groups and key opinion leaders through the provision of data and information on the therapeutic areas in which we specialize. In our business dealings.

Our Sales, Marketing and Medical Science Liaison (MSL) professionals are given thorough training on their respective functional local regulations and Shire’s standards. We strive to uphold the most stringent adherence to commercial and medical regulatory requirements and obey industry promotional and non promotional guidelines for each country in which we operate.

In Europe we comply with the European Federation of Pharmaceutical Industries and Associations (EFPIA) code of practice and have a rigorous internal approval system including Medical and Regulatory department approval to ensure compliance. In the U.S. we have a robust process in place to assure compliance with the Food and Drug Administration (FDA) regulations regarding promotional activities and have adopted policies and programs consistent with those recommended by the Office of Inspector General Compliance Program Guidance for Pharmaceutical Manufacturers and the Pharmaceutical Research and Manufacturers of America. For other areas we use the core policies and adapt when necessary to include those local code provisions that are stricter than perhaps these core policies are. Otherwise all other codes are country specific.

• Continued to promote high standards of ethics and integrity, including:

• Our compliance team have been working with country General Managers to provide training to assist in carrying out their responsibilities as leaders in maintaining Shire’s standards of ethics and integrity.
• As we enter new markets and as new business models are developed care is taken to ensure that the Shire standards of ethics and integrity are an integral part of our development plans.

• Continued to update our policies and procedures on ethical conduct and training employees and partners to ensure compliance across the world:

• Speciality Pharmaceuticals (SP) global promotional guidelines were launched this year to set a global standard for the communication of information. This has resulted in a new Standard Operation Procedure (SOP) in SP for the approval of materials to ensure those guidelines are met.  The Policy / SOP Core team reviewed a substantial number of the existing policies that set Global standards across functions when dealing with Healthcare Professionals (HCPs) (The remainder will be completed in 2013). They also completed local adaptations of global polices in countries/ regions such as Russia, Turkey, Latin America and Japan.
• An updated anti-bribery and corruption (ABC) policy was approved by the Board in Feb 2012 and rolled out via online training to all at Shire, together with training on privacy and data protection, Fair Market value tool training and other regular training such as adverse event reporting.
• A   program of face to face training on Anti-Bribery and Corruption, “Do you know your ABC” was rolled out across the businesses to colleagues and distributors.
• Training on data privacy and protection was expanded to include agencies and distributors.

• Implemented the Corporate Executive Board’s (CEB) Business with Integrity Survey to better understand employees’ views on our ethical culture, and assessed and appropriately acted upon the findings

• This was conducted up to 31 March 2012 with 58.9% of employees completing it. The results showed that the main areas for improvement were increasing awareness and clarity of expectations and action steps have been developed to address these.
• Regular presentations of the results have been done and will continue into 2013. The compliance team have worked with functions to devise appropriate functional action plans.

• Further audited Shire’s local operating companies and business partners, helping to ensure that Shire’s policies are adhered to.
• Put in place processes to ensure that in 2013 Shire is evaluating transparency reporting requirements on areas such as payments to HCPs both in the US and throughout the globe.

• Introduce an updated Code of Ethics to all colleagues and ensure all employees are trained in its implications
• Respect our customers and the patients we serve by respecting their privacy.  Ensure that we incorporate privacy by design into all of our processes that collect personal, sensitive, or confidential data to protect it from loss or misuse.
• Continue to actively promote high standards of ethics and integrity through leadership, communications and training
• Continue to update our policies and procedures on ethical conduct and training employees and partners to ensure compliance across the world
• Implement the agreed action plan from the 2012 Business with Integrity Survey to ensure we act on the feedback from the survey in such a way to enhance our ethical culture