One of our most important responsibilities is to ensure that the people affected by the conditions we treat are given the support they need, and the conditions themselves are properly understood and adequately funded.
This means we actively engage with policymakers, as well as other companies and non-governmental organizations, to advocate for a policy and regulatory environment that supports innovation and value that will benefit patients, healthcare systems and society. This includes working to improve access to medicines, awareness and understanding of the sometimes complex or misunderstood conditions our products treat, and supporting investment in and advancement of new medical breakthroughs. We also engage in discussions pertaining to pricing and reimbursement, patient data and information, and diagnosis and detection.
Our dedicated global public policy team operates in Brussels, London and Washington, DC.
Reflecting on 2012
We continued to work with patient organizations and other partners to make the case to policymakers for more funding for rare disease treatments. In 2012, we:
- Took an early leadership role in discussions between the FDA and advocacy organizations on the FDA Safety and Innovation Act (FDASIA) 2012 legislation, surrounding provisions for the development of therapies for rare diseases. This focused on delivering:
- Priority review vouchers for rare pediatric diseases
- Fast track approval/novel approaches to surrogate endpoints
- Breakthrough therapies
- Co-led projects of the European orphan drug industry task force of European Biopharmaceutical Enterprises and EuropaBio aimed at forging EU stakeholder understanding of the value and specificity of the rare disease business models. Joined the International Rare Disease Research Consortium (IRDiRC) co-founded by the European Commission and US National Institutes of Health alongside other major research funding agencies, and Shire’s Phil Vickers was appointed to the IRDiRC Executive Committee.
- Worked closely with 2020Health, an independent healthcare think tank, to support the research and production of a report looking at access to orphan medicines. Entitled ‘Orphan Medicines: special treatment required?’, the report was authored by an independent health economist. The report analyses the complex framework that influences patients’ access to orphan drugs and seeks to make suggestions for better decision making and how to improve access for all to orphan drugs.
- Continued raising awareness of ADHD as a serious medical condition impacting patients and society, and the need for early diagnosis and long-term management of this chronic disorder:
- Organised a European Expert Roundtable on the impact, cost and long- term outcomes of ADHD in Brussels on 27 November 2012, with over 20 leading experts from patient advocacy groups, academia, mental health and education policy stakeholders in attendance. Recommendations from this expert roundtable will be published as part of a multi-disciplinary European White Paper, which should be released in the spring of 2013.
- Continued to support the work of the Better Futures Group, a multidisciplinary group of experts in ADHD. Among other activities this year, the Better Futures Group held a parliamentary roundtable dinner hosted by Lord Bradley to raise awareness in parliament of ADHD and discuss the opportunities presented to provide better futures for children with ADHD in the forthcoming Children and Families Bill.
- Raise understanding among policymakers of the opportunities for patients that Regenerative Medicine provides:
- As the House of Lords Science and Technology Committee launched its inquiry into regenerative medicine, we submitted evidence of our positive experience of working with the MHRA in this area
- Joined the newly formed Alliance for Advanced Therapies (AAT) in Europe.
- Work with legislators, policymakers and regulators, to continue to make the case for greater and faster patient access to medicines:
- Provided input to the Agency for Healthcare Research and Quality technical report on enzyme replacement therapies for lysosomal storage disorders.
- The Health and Sport Committee at the Scottish Parliament held an inquiry into access to medicines in Scotland and Individual Patient Treatment Requests and Shire submitted evidence to the Committee and held a number of stakeholder meetings to help them understand the challenges faced by companies trying to make medicines for rare and very rare conditions available to Scottish patients.
Communicated the importance to policymakers of a well functioning system that encourages innovation:
- Created policy papers on the topics of intellectual property, innovation and access to medicines.
- Produced two policy position papers on Ecosystem of Innovation and Access to Medicines
- Arranged stakeholder meetings so that companies can support investment in and advancement of new medical breakthroughs.
- Shire CEO visited Washington, DC to meet with policymakers, patient and advocacy groups and thought-leaders to better understand their needs and inform on what Shire is doing to make a positive difference.
- Took up a seat on the Ministerial Industry Strategy Group in the UK – a high level forum which fosters dialogue between Government, civil service, NHS and industry. Shire increased up its participation in leading pharmaceutical & biotechnology industry associations in Europe. We joined the European trade association EFPIA and the UK trade association ABPI during the second half of 2012. Shire representatives were appointed to the Board of Directors of EuropaBio and the Board of Management of ABPI.
Commitments for 2013
- Engage with policymakers to support improved patient access to medicines
- Encourage policies that recognize patient and societal benefits of innovation
- Advocate greater understanding among policymakers of the societal value of orphan drugs
- Raise awareness and understanding among policymakers of ADHD and other behavioral health conditions as serious medical conditions that require/ warrant early diagnosis and management because of their impact on patients and society.
- Advance recognition among policymakers of opportunities for patients provided by regenerative medicine
"Our public policy priorities reflect our fundamental purpose: to enable access for patients with life altering conditions to lead better lives."
Sponsor of Public Policy
Vice President, Global Government Relations and Public Policy
Leading the way in Washington
People who work in biopharmaceuticals might think that the policy environment in which the company operates doesn’t change,” says Ted Buckley, who directs Shire’s U.S. Government Relations and Public Policy Team. “But the fact is that we’re working every day to help policymakers understand just what is at stake and what patients need. This is an exciting, fluid field. Laws and regulations can change as understanding does.”
Shaping European Policy with Patients in Mind
Shire recently joined the European Federation of Pharmaceutical Industries and Associations (EFPIA). This means we can play a bigger role in shaping European healthcare policy with patients in mind as well as defending against cuts to public healthcare budgets. We will also benefit from EFPIA’s market and policy intelligence, meetings and influence in Brussels and across the region. This will help us better understand and influence policy and regulations at the European Union and country levels, and support the Federation’s focus on growth, competitiveness and trade.