Interactions With Government


Governments play a critical role for the healthcare industry, specifically with the development of reimbursement frameworks and product access regimes across CSL's entire value chain. CSL recognises the importance of participating in political and public policy matters that directly impact business operations. Public policy initiatives are primarily focused in Australia, Asia, Europe and North America where appointed senior personnel are responsible for engaging with governments and other key stakeholders on public policy matters.

In Australia:
  • CSL provided both a written submission and participated in verbal consultation with the Victorian Government in support of the development of a plan for Medical Technologies and Pharmaceuticals, one of ‘Victoria's Future Industries'. CSL made several recommendations noting that Victoria is a world leader in medical research and biotechnology and that the Parkville precinct, in particular, is a world-class biotech hub.
  • We contributed to the Australian Government House of Representatives Standing Committee on Economics' inquiry into tax deductibility. CSL submitted that removing the existing tax deductibility on interest incurred by businesses would impact growth and productivity by increasing the cost of debt-financed investment and thus reducing the incentive for investment by Australian companies.
  • CSL continued to actively support the Australian Government's establishment of a new Medical Research Future Fund. It is intended that this fund will eventually have a capital value of A$20 billion with the annual interest disbursed as grants. CSL contributed to consultation on the fund's strategy and priorities and submitted its overarching strategy should be to ‘maximise the social and economic benefits of Australian medical research'.
  • We made a written submission and gave verbal evidence to the inquiry by the Australian Parliament's Joint Select Committee on Trade and Investment Growth on Australia's Future in Research and Innovation. CSL recommended that government track the value-chain and international movement of Australian intellectual property and initiate some innovative reforms designed to position the nation as a global competitor and keep intellectual property onshore for as long as possible.
  • We provided both written evidence and participated in a verbal consultation with Australia's Chief Scientist in relation to the ongoing review of the existing research and development (R&D) tax incentive. CSL submitted that reducing or restricting the incentive may result in a reduction of onshore R&D.
In Europe:
  • As a member of the Plasma Protein Therapeutics Association (PPTA Europe), CSL contributed to a constant dialogue with the European Commission for consideration of whether and how modifications to the European Blood Directive should be enacted.
  • Our 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, mainly due to budgetary constraints of member states. We submitted 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 continues to engage with payers, politicians and stakeholders to advance new pathways and healthcare infrastructure for better diagnosis and treatment of rare diseases across Europe. We are working closely with Germany's Federal Joint Committee (G-BA) and Federal Ministry of Health to develop concepts to increase diagnosis and treatment for patients with rare diseases. CSL is also working across various rare disease conditions to help define productive pathways and patient-tailored value-added arrangements that can provide better care for patients, adequate reimbursement for treating healthcare providers and by better demonstrating the value generated to those who provide funding for the treatments.
  • EURORDIS, the European rare disease patient umbrella organisation, and partners brought together industry, patient leaders, academics, regulators and payers in a multi-stakeholder symposium to discuss the current state of play and how to shape a more effective way to address value determination, appraisal, pricing and reimbursement of orphan medicines. This symposium was aimed at improving patients’ access to rare disease therapies throughout Europe and was connected to the annual international Rare Disease Day 2016. CSL Behring supports the development of the effort and program and served on the program committee with stakeholders.
  • CSL Behring was nominated to the leadership group for a key project with the European Working Group (EWG) on Health Technology Assessments (HTA) for Orphan Medicinal Products – OMP (Value Assessment and Funding Processes in Rare Diseases). The overarching objective is to shape the development of OMP systems in European markets to ensure optimal and sustainable patient access to orphan products. Principles for assessing the worth and value for money of orphan medicinal products in the EU have been drafted and shared in a public consultation.
  • CSL Behring is also working with stakeholders on a concept of having patients with Alpha-1 be recognised and diagnosed under the broader chronic obstructive pulmonary disease management program and the German Ministry of Health has signalled conceptual support.
  • CSL Behring is working in cooperation with politicians and governmental authorities in different European countries on developing healthcare management tools for patients with rare diseases. In Germany, in cooperation with the Federal Joint Committee (G-BA – the highest decision-making body of the joint selfgovernment of physicians, dentists, hospitals and health insurance funds in Germany) and health insurance companies, we are developing a healthcare economic concept of a high cost treatment budget which can secure the financing of diagnostic and treatment of rare diseases.
In the US:
  • CSL Behring led an industry effort to help convince the state legislatures of Alabama and Nebraska to appropriately reduce the age of plasma donation from 19 to 18 years of age. These two states are now in line with all other states for the minimum age of plasma donation.
  • CSL Behring is a leader in efforts with the US Congress to retain the US Orphan Drug Tax Credit (ODTC). The US Congress is beginning to float concepts for corporate tax reform, including a reduction in the overall US corporate tax rate and they are looking at dropping a number of tax credits. The ODTC is integral to the Orphan Drug Act and important to encouraging the development of therapies for the thousands of untreated rare diseases.
  • Through a collaborative effort with the Hemophilia Council of California, outreach with the California legislature resulted in a cost sharing bill being signed by the Governor capping patient out-of-pocket cost for prescription drugs to US$250 per 30-day supply of therapies, providing greater access and less burden to patients.
  • CSL is actively advocating to the US Congress to exclude therapies solely licensed for the treatment of rare diseases from an annual pharmaceutical fee. Certain plasma therapies are not included in the rare disease exclusion even though they solely treat rare disorders. CSL has partnered with legislative champions in the House and the Senate, in addition to the National Organization for Rare Disorders and several specific patient organisations representing individuals using plasma/recombinant therapies, to correct this situation.
  • In the province of Ontario, Canada, CSL has been engaged in an ongoing effort with the Health Ministry, in tandem with six provincial hospitals, to promote the creation of a pilot project where the ministry would fund nursing services associated with the administration of subcutaneous immunoglobulin. At present, the province covers only intravenous immunoglobulin administration in a hospital setting, but will not cover nursing services for subcutaneous administration. We have argued, and the Health Ministry has agreed, that providing greater access to subcutaneous therapy through nursing services could actually save costs over time. The Health Ministry supports the pilot and are awaiting final word from the health economics agency before moving forward.
  • Seqirus conveys information on new and innovative products and their potential to reduce the burden of disease to policymakers, providers and the public. In the last year, to assist policymakers in their decisions and recommendations, presentations were made to the Vaccines and Related Biological Products Committee (VRBPAC) of the FDA and the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC). On product licensure, numerous additional presentations were made to scientists, key opinion leaders and stakeholder groups such as provider organisations.
  • Seqirus maintains a supportive environment for public health and the uptake and usage of influenza vaccines through the provision of grants to the National Foundation for Infectious Diseases (NFID), the National Adult and Influenza Immunization Summit (NAIIS), and the European Scientific Working Group on Influenza (ESWI). These organisations create, provide and maintain numerous educational and public awareness activities around influenza prevention and treatment for the public, providers and policymakers in the US and Europe. The burden of influenza disease is particularly severe in the over 65 years of age population. To assist public health, raise awareness, and reduce morbidity and mortality, Seqirus additionally provided a grant to NFID to host a scientific roundtable on the burden of influenza disease in the population over 65 years of age, vaccines available for usage, and the need for vaccination to educate providers, and also a grant to the Alliance for Aging Research (AAR) for public education and awareness on immunisations for adults.

POLITICAL CONTRIBUTIONS

CSL's CRBP and Global Statement on Political Contributions define our approach for the financial support of political organisations.

CSL undertakes financial contributions to political parties and candidates as part of engaging in the political process and ensures compliance with specific jurisdictional laws and regulations as relevant. In addition, political contributions are made in accordance with global and local authorisation levels.

Over the reporting period, CSL contributed a total of US$18,804* to political organisations in Australia and the US. The contribution comprised support for candidates in US state-based elections and in Australia, contributions towards attendance at political party conferences, roundtables and/ or fundraising events (such as breakfast briefings/ luncheons or dinners). In all other regions, CSL made no political contributions.

CSL also provides for the administrative costs of a political action committee (PAC), whereby eligible employees in the US voluntarily contribute to the PAC to provide contributions to political candidates who support patient care and policies to enhance biopharmaceutical innovations. The PAC is run by an employee PAC Board and is fully compliant with US election laws and reporting requirements.

Country Contribution
US (US$) 3,000
Australia (A$) 21,699

* When converted to US currency and excludes operations acquired from the Novartis influenza vaccine business.