2017/18 Public Policy Initiatives
- CSL has continued its engagement with the Australian Federal Government and the medical research sector in relation to the research and development (R&D) tax incentive. Significant changes were announced in the Federal Budget in May 2018 and although there were substantial savings measures, advocacy by the biotech sector resulted in several concessions acknowledging the particular financial challenges of the biotech sector. CSL provided a written submission to consultation on the draft legislation.
- CSL responded to the establishment of a federal government inquiry into “Impediments to Business Investment” by initiating a policy coalition with Cochlear, the Australian-based hearing implant manufacturer. Together, as Australia’s two most successful innovation-focused, advanced-manufacturing companies, we engaged in written and verbal advocacy focused on enhancing Australia’s international competitiveness and maximising the social and economic benefits flowing from innovation. We argued that the Australian Government should conceptualise and plan for a competitive Australia, counted within the top tier of innovation nations, known and respected for its welcoming business environment and excellence in science, research and commercialisation. Our key points were that Australia needs an internationally competitive business environment, including the taxation and regulatory regimes; that constant policy change, or change without consultation, undermines business confidence; that a globally mobile workforce is necessary to support Australian companies with a global export focus; and that it makes sense to support areas of competitive advantage, including supporting research hubs and initiatives to keep Australian intellectual property onshore for longer.
- In Victoria, CSL made a submission to the government’s Victorian Jobs Partnership initiative. We argued that Victoria needs a globally competitive and consistent business environment to sustain and attract future investment. We suggested that Victoria should nurture and enhance health precincts, maintain and enhance research infrastructure and that co-investment and local procurement can help support Victorian jobs.
- CSL has also actively engaged in various other policy issues directly and through our major industry associations, AusBiotech and Medicines Australia.
- CSL Behring’s public policy efforts, in concert with European trade associations, were targeted at maintaining a supportive environment for innovation in rare disease therapies and orphan drugs. There are growing challenges in securing patient access to new orphan drugs, largely due to budgetary constraints of member states. We advocated that new policy initiatives should aim to establish Health Technology Assessments (HTA) and value assessment approaches that would streamline and accelerate patient access across different countries and have measures appropriate for these critical rare disease therapies.
- CSL Behring conducted the first “Rapporteur Dialogue” in the German Parliament (June 2018) with the rapporteurs for pharmaceuticals and/or blood and blood products in the political parties of the German Bundestag and the new Head of the Department for Pharmaceuticals, Medical Devices and Biotechnology of the Ministry of Health. The dialogue addressed the uniqueness of plasma protein therapies and potential differentiation in rebate contracts and discount agreements.
- As member of PPTA and EuropaBio, CSL Behring contributed to the European Commission consultation on EU blood legislation in August 2017, with input to comprehensive trade association and company responses to reinforce our policy positions for the plasma sector. Key advocacy issues relate to the differentiation between blood for transfusion and plasma for manufacturing, impact of self-sufficiency, donor compensation and developing an environment to foster plasmapheresis to obtain plasma in Europe. Advocacy is through direct advocacy with key European stakeholders such as members of the European Parliament and representatives of the European Commission as well as with national competent authorities. CSL Behring likewise contributed to PPTA’s interaction with WHO and the Council of Europe (Committee on Bioethics) with regard to initiatives on donor compensation ethics.
- As a member of the industry trade association European Confederation of Pharmaceutical Entrepreneurs (EUCOPE), CSL Behring collaborated with the “Multi-Stakeholder Working Group for the Value Assessment and Funding Process in Rare Diseases” (ORPH-VAL), consisting of patient representatives, physicians, academics, HTA practitioners, politicians and pharmaceutical industry representatives. CSL Behring’s Health Policy and External Affairs (HPEA) team has been continuously driving national level assessment of the recommendations developed by ORPH-VAL, including leadership in preparation of panels with payers from key European countries at international conferences.
- To mark the first European Alpha-1 Awareness Day in April 2018, CSL Behring organised an EU roundtable discussion in Brussels with 30 specialists and patient representatives. Participants exchanged information on best practices in early testing and care of alpha-1 antitrypsin deficiency, access to available treatments and how to increase awareness and education of the disease amongst general practitioners and specialists.
- In May 2018, CSL Behring served as theme leader for a two-day track on “Economical Perspectives in Rare Diseases” at the European Conference on Rare Diseases & Orphan Products (ECRD) in Vienna entitled “Rare Diseases 360° – collaborative strategies to leave no-one behind”. CSL Behring likewise joined a panel on “Global Access to Timely Accurate Diagnosis and Optimized Care” to outline our patient commitment and well-established collaborations in concert with the haemophilia community. ECRD is the largest multi-stakeholder-gathering in Europe for the rare disease community, taking place every two years, and organised by Rare Diseases Europe (EURORDIS), Orphanet and Drug Information Association (DIA).
- As an active member in Vaccines Europe, Seqirus participated in priority setting for the European Commission’s on Joint Action on Vaccination (JAV) s as well as the development and launch of an evidence-based influenza vaccine manifesto to raise awareness about the social and economic burden of influenza in European countries. JAV seeks to develop a framework for cooperation and strategies to address issues related to vaccination and preparedness.
- Seqirus is also part of a public private partnership that was successful in obtaining funding from the Innovative Medicines Institute to develop a sustainable study platform for the conduct of vaccine brand-specific effectiveness studies. The partnership, called the Development of Robust and Innovative Vaccine Effectiveness (DRIVE), brings together the influenza vaccine industry and public health institutes and government agencies from across Europe to enhance the understanding of influenza vaccine effectiveness studies, inform public policy and meet new regulatory requirements.
In North America
- CSL Behring actively engaged with the US Congress as it developed major tax reform. We supported efforts to adjust marginal tax levels and policy to further support investment in innovation and growth. The Orphan Drug Tax Credit was maintained, albeit at a reduced level, despite calls by some to eliminate it. Some proposals that could have been harmful to maintaining efficient international supply chains were modified. CSL Behring worked with affected parties, including patient groups and specialty pharmacies, to successfully advocate that an administration payment for subcutaneous therapy be moved forward to help assure full access to these important therapies.
- CSL Behring submitted written comments on President Trump’s administration’s drug pricing policy blueprint and request for information, emphasising the need to assure patient protections and access to care as revisions to federal and state reimbursement are considered.
- CSL Behring is working to protect patient access to therapies by championing legislative efforts to mitigate step therapy proposals and by opposing policies that shift undue burden of cost onto patients through restrictions placed on the use of manufacturer assistance programs.
- We continue to work to improve state regulatory environments in support of plasma collection, reducing redundancies with federal law, thus maintaining high donor and patient safety standards while improving efficiencies in centre operations.
- CSL Behring continues to support patient advocacy organizations through the Local Empowerment for Advocacy Development (LEAD) grants. In 2017/18, eight grants were awarded totalling US$74,000. Funded projects are focused on patient group programs to protect access and educate policymakers on the unique needs of patients with rare diseases. This is in addition to other significant core grants to such organisations.
- CSL Behring has led efforts in multiple states to preserve appropriate reimbursement for blood clotting factors to ensure patients have access, most notably in California.
- Seqirus continued its leadership of The Alliance for Biosecurity this year, taking on the role of Chair after co-chairing since 2016. The Alliance is a coalition of biopharmaceutical companies and academic partners that promotes strong public-private partnerships to ensure medical countermeasures are available to protect US public health and enhance national health security.
- During the period, the Biotechnology Innovation Organization (BIO) invited Seqirus to co-chair the Biodefense Policy Action Committee (BDPAC) for a 2-year term. BIO is the world's largest trade association representing biotechnology companies, academic institutions and state biotechnology centers across the United States and in more than 30 other nations.
- As an active member in BIO, Seqirus supported a state-level immunization confidence campaign to challenge proposed regulation/legislation that hinder access to vaccines. This project is focused on five key states where vaccine hesitancy has increased and offers support and research to provide accurate and truthful information about vaccines.
- Seqirus was also been active in advocating for the FDA to allow the inclusion of real-world evidence into vaccine labels as well as supporting policy work associated with enhanced influenza vaccines for older adults through grants to Families Fighting Flu, National Foundation for Infectious Diseases and the Alliance for Aging.
- Seqirus was active in its first full year as a member of the International Federation of Pharmaceutical Manufacturers Association (IFPMA), raising the awareness of influenza as an important policy issue. Seqirus also heightened collaboration with WHO and other industry partners involved in the IFPMA Influenza Vaccines Supply Taskforce to advance progress in pandemic influenza preparedness.
- Seqirus also supported the efforts of The Partnership for Influenza Vaccine Introduction (PIVI) a key program of The Task Force for Global Health to create sustainable, routine, seasonal influenza vaccination programs in low- and middle-income countries, and became a member of the Global Health Security Agenda (GHSA) Private sector Roundtable (PSRT) which aims to mobilize industry to help strengthen systems for health security.