Policy Overview and Policy Positions
Biogen participates in public policy discussions to benefit our patients and foster innovation and growth in the industry.
We have positions on a number of key issues, including:
ENSURING PATIENT ACCESS
Sufficient protections should be in place to establish healthcare systems that ensure timely patient access to the most appropriate healthcare providers, services and treatments. Provider networks, within both private and public health plans, should allow patients to receive coordinated care not only from their primary providers, but also from specialists and subspecialists who may be necessary to best treat their condition. Patients should be able to choose the healthcare providers with whom they have the most confidence and trust. Additionally, comprehensive formulary coverage will ensure that the decision as to which medicine to use is best made by the patient and their physician. As scientific progress leads us down the path toward more innovative, effective and personalized treatments, it is increasingly important that patients gain the most value from these advancements.
Intellectual property (IP), including patents and regulatory data protection, is the lifeblood of the biotechnology industry. It takes an average of 10 years and more than $1 billion to bring a new therapy to market. Additionally, only 20 percent of products that start the clinical trial process in humans eventually become therapies for patients. Lengthy and high-risk product development periods require strong IP protections to attract the investment the industry needs to fund research and development of lifesaving therapies.
Biogen supports a predictable legal framework that ensures strong IP protections. Fair and effective incentives are necessary for continued biomedical innovation and ongoing investment in research to fund new treatments and cures for patients facing the most challenging diseases.
CLINICAL TRIALS DATA TRANSPARENCY
Biogen is committed to advancing public health through responsible sharing of clinical trial data in a manner that is consistent with the following imperatives:
- Safeguarding the privacy of patients,
- Preserving scientific rigor and trust in regulatory systems, and
- Maintaining incentives for investments in biomedical research.
Biogen publishes its clinical research, collaborates with academic researchers and shares clinical trial information on public websites, such as clinicaltrials.gov, at the time of patient recruitment, after marketing authorization and when investigational research programs have been discontinued. Biogen adheres to the Principles for Responsible Clinical Trial Data Sharing, jointly adopted by our trade associations, Pharmaceutical Research and Manufacturers of America (PhRMA) and European Federation of Pharmaceutical Industries and Associations (EFPIA). In line with the principles, Biogen is committed to:
(i) Enhancing data sharing with researchers,
(ii) Enhancing public access to clinical study information,
(iii) Sharing results with patients who participate in clinical trials,
(iv) Certifying procedures for sharing clinical trial information, and
(v) Reaffirming commitments to publish clinical trial results.
REAUTHORIZATION OF THE PRESCRIPTION DRUG USER FEE ACT
The Prescription Drug User Fee Act (PDUFA), enacted in 1992, authorizes the U.S. Food and Drug Administration (FDA) to collect user fees from companies that develop prescription drugs. These fees are then used to fund the review and approval of new drugs by the FDA. PDUFA, which has been renewed every five years since it was first enacted, is up for reauthorization in 2017.
PDUFA has played an important role in expediting the approval of safe and effective medicines. As PDUFA comes up for reauthorization, we support regulatory reforms, including those that target clinical trials and regulatory science, to reduce development and approval timelines and accelerate the availability of treatments for patients with unmet medical needs.
Biosimilars, which are subsequent versions of innovative biological products, have an important role to play in providing high-quality therapies to patients at a lower cost. While innovation continues to be a key driver of health care, access to high-quality therapies at lower costs is also important. As an industry, we have a responsibility to address both innovation and access. To that end, we support the creation of a well-functioning market for biosimilars while protecting patient safety, ensuring product efficacy and promoting the continued innovation of the biotech industry.
CORPORATE TAX REFORM IN THE U.S.
Reforming the corporate tax code is needed to stimulate the U.S. economy and make U.S. companies more globally competitive. An important tax reform to spur domestic job and economic growth would be the creation of an appropriately designed innovation box. An innovation box regime would incentivize U.S. and foreign companies to locate their intellectual property (IP) and corresponding economic activities — such as research and manufacturing — in the U.S. by reducing the corporate tax rate on income earned from the qualifying IP. In order to lead the world in scientific discovery and innovative industries, public policies that support those goals, such as a well-designed innovation box regime, must be part of a reformed U.S. corporate tax system.
Biogen recognizes that traditional pharmacy compounding can play a useful role in personalizing a treatment for an individual patient or patient subpopulations. As such, pharmacy compounding operations should be small-scale in nature and limited to those cases in which the pharmacy receives valid prescriptions for the individual patient(s) in question. Large-scale compounders of prescription drugs should be required to comply with good manufacturing practices outlined by regulators in order to ensure that products meet all necessary quality and safety standards. When an approved compliant version of a drug is available, patient safety should not be placed in jeopardy by allowing compounding pharmacies to produce an unauthorized version of the drug that may present safety, efficacy and manufacturing risks.
For more information on our public policy activities, please see our 2014 Corporate Citizenship Report.