Compliance and Quality: All Shire sponsored trials are conducted under GCP (Good Clinical Practice) standards and adhere to the ethical principles set out in the Declaration of Helsinki.
Site Monitoring’ SOPs are being upgraded. SOPs for ongoing safety data review at the subject and study level are being introduced.
Safety: High standards of safety monitoring and reporting are applied for the protection of subjects and patients enrolled in clinical Shire sponsored studies and patients using Shire’s marketed products.
New SOPs on protocols and on Safety Review Teams are being implemented: Monthly review of post-marketing data for safety signal detection purposes has been fully implemented. Standard data displays for periodic reviews of integrated data from clinical trials on a product level are being developed to enhance proactive safety monitoring.
Patient Information: Patients and subjects are informed about the principles and potential risks of clinical trials.
A new informed consent procedure is in place and global consent templates have been enhanced.
Risk Management: Effective risk management practices during the post-marketing period assess risks to patients and seek to minimize risks, utilizing high quality educational and outreach programs aimed at patients and healthcare providers.
The new SOP on Safety Review Teams becomes effective in August 2007; it integrates the risk management planning process into the activities of the team. Risk management plans for various products have been implemented.
Medical Information: A clearly identifiable resource is available to manage all medical, pharmaceutical and technical enquiries relating to Shire’s products to support their safe and effective use.
A competency-based training program for call center personnel has been developed and implemented. Guidelines to harmonize response preparation and provision across regions are under development.
Animal Testing: Minimize animal use and ensure high standards of animal care.
Internal justification processes showing careful consideration of the necessity of animal use are in place. External vendors performing studies on Shire’s behalf comply with ethical review and animal welfare requirements.
Ensure Shire becomes involved in appropriate activities and initiatives that assist development of the communities where the company has operations.
Shire is a member of the UK’s Percent Club for companies which donate at least 1 per cent of their pre-tax profits to charitable causes. Shire featured in the UK’s Guardian Giving List which lists FTSE 100 companies by the percentage of pre-tax profits contributed to charitable causes. This was based on our donations reported in 2006.
Shire’s principal sites have their own plan of community activities; the highlights of which are reported on the company’s intranet and included in the annual CR report.
Collect and disseminate information about Shire’s financial support for community initiatives.
Information collection and reporting is ongoing.
Improve employee awareness about the company's community activities and encourage involvement and participation.
Shire’s Community Policy is posted on the company’s intranet and main Shire website. Further community activities publicity is to be generated in global company newsletters and through the employee communications strategies.
Enhance Shire’s reputation and image by developing and maintaining a consistent level of sustainable relationships in our community activities where Shire employees live and work, and where Shire has a significant presence
Summary of organizations and activities across Shire sites
Ensure data on Shire’s community investments accurately reflects the Company’s widespread activities.
Create and ensure population of a data collection tool on community investments. Collate information on the company’s charitable actions and community initiatives annually
Enhance employees’ opportunities to participate in community initiatives
Increase awareness of employee involvement (volunteerings scheme) and fund-raising ‘matching’ policy
Gain employee feedback on effectiveness and relevance of Shire’s community activities.
Develop and complete an employee survey by site to assess perspective of Shire’s community giving and support.
Enhance employee awareness about the company’s activities and share best practice
Publicize Shire’s community activities within the company communications
Complete development and implementation of a Global Environmental Health and Safety ("EHS") Management System that will result in the provision of a safe and healthy workplace for all Shire employees.
In 2006, Shire formalized, implemented and communicated its EHS platform document and major EHS standards. Shire EHS Department conducted second party assessments of its operations at its sites to ensure procedures and rules were consistent and compliant with Shire’s global standards and local laws, regulations and rules.All Shire sites achieved recordable rates below the pharmaceutical average of 3.0. In 2007, we will strengthen our systems to sustain our performance at an injury /illness recordable rate (as defined by the safety and health authorities in each country) below 3.0 for each of our locations.
Establish a culture and supporting systems that integrate EHS into different functions, meetings, process planning, supplier selection, engineering design, etc.
In 2006, EHS presence was established in important decision-making processes. New Hazard Review software was utilized to facilitate the review process. EHS integration was accomplished in formal review committees including New Product Review Teams, Process Improvement Teams, and Supplier Review Boards. In 2007, we will monitor and document EHS input into these processes.
Continuous improvement in the safety and health of employees through sustaining a global EHS Training Program for all employees.
In 2006, EHS Training matrices were established and training programs were implemented throughout Shire. In 2007, Shire will utilize learning management systems to deliver EHS training to key locations.
Assure Shire, as well as our key suppliers base meets or exceeds all regulatory requirements globally.
EHS Assessments were conducted at all Shire sites and at key supplier locations. Assessments were documented and assessment recommendations were reviewed with sites and suppliers. Contractors and subcontractors attend Shire induction training and EHS reviews before commencing work at Shire locations.
In 2006, there was no environmental, health, or safety impact to the communities in which we conduct our business. In 2007 we will expand our assessments to global suppliers.
Develop and implement with the support of HR-Benefits a Global Health/Wellness program that utilizes existing offerings and adds supplemental programs to strengthen.
In 2006, Safety, Health, and Wellness Fairs were conducted at our Chesterbrook, Florence-US, Owings Mills, and Cambridge, US, and Basingstoke locations. Wellness profiles, tracking key health indicators, were established for employees. Over 1000 employees participated in the safety, health, and wellness program during its first year. In 2007, the program will be expanded to our European and Canadian locations.
Encourage suppliers to embrace Corporate Social Responsibility standards substantially similar to Shire’s own and work with suppliers to share best practice and, if appropriate, help suppliers improve their best practice.
Supplier corporate responsibility audit assessments are on-going. Database of supplier corporate responsibility audits being generated. Supplier mailing of Shire’s expected standards scheduled for later this year (2007).
Shire's Environment, Health and Safety Mission statement and corporate responsibility policy shared with suppliers. A document outlining environmental and social performance expectations is being developed.
Supplier conferences were held in the UK October 11, 2006 and in the US on November 6, 2006. Corporate Responsibility, Ethics, Supplier Diversity and an overview of Shire’s business was communicated to all suppliers in attendance.
Require all contractors and sub-contractors to comply with Occupational Safety & Health Administration ("OSHA") and Shire’s safety standards.
Shire is developing a contractor safety standard that will require all contractors and their sub-contractors to comply with OSHA and Shire’s safety standards. The contractor safety standards also require periodic audits to monitor compliance. Included in the standard, and already implemented, is the requirement that all contractor’s and sub-contractor’s employees must receive safety training prior to starting work. All such employees are to acknowledge in writing that they have attended the training and understand the safety standards.
A contractor safety orientation video has been developed by Shire and has been utilized to facilitate compliance with Shire safety standards. Safety audits are on-going.
Support patient education and disease state awareness in key disease areas in accordance with all applicable laws, rules, regulations, codes and guidelines.
Generation and dissemination of disease stale educational materials is ongoing. Actively engaged with industry bodies such as:
Ensure marketing and selling practices are ethical and in compliance with relevant laws, rules, regulations, codes and guidelines.
During 2006 Shire updated its UK policy relating to review and approval of promotional materials.
Ensure marketing and selling practices are ethical and in compliance with US laws, rules, regulations and guidelines.
Ensure medical, legal and regulatory review of all promotional materials used in the marketing and promotion of Shire’s US products in order to seek full compliance with all applicable laws rules, regulations and guidelines including the OIG (Office of Inspector General) guidelines.
The following US policies have been completed or updated. Training of Marketing and Business Unit personnel was conducted during the year on the use and operation of the new US standard operating procedures.
Support patient education and disease state awareness in key disease areas in accordance with all applicable laws, rules, regulations and guidelines.
Actively engaged with bodies such as NORD (National Association of Rare Diseases), ADDA (Attention Deficit Disorder Association) CHADD (Children & Adults with Attention-Deficit/Hyperactivity Disorder) NASPGHAN (North American Society for Pediatric Gastroenterology, Hepatology and Nutrition), National Kidney Foundation and Epilepsy Association
Patient education materials across all three of Shire’s specialty pharmaceutical Business Units were disseminated in the US by the Shire sales forces throughout 2006, with new materials developed on a quarterly basis.
Use of e-marketing tools in the US, where permitted, including ADHDsupport.com, your ADHD Resource Center, and ManagingUC.com websites throughout 2006.
Launch of shiregrants.com website for managing US Continuing Medical Education (CME) grant requests to ensure that such requests are appropriately separated from the marketing side of the organization.
Provide medications on compassionate basis to those in the US who cannot afford them.
Widespread use of Patient Assistance Programs ("PAP’s") for Fosrenol, Adderall XR, Carbatrol, Daytrana and Pentasa in the US. US PAP for indigent patients initiated for Adderall XR from January 3, 2005
© Shire 2008