Eli Lilly and Company » Positions on Key Issues

Skip to: Affordability and Access, Health Care Reform, Integrated Health Care Systems, Comparative Effectiveness, Follow-On Biologics, Intellectual Property, Importation, Medicare Part D

Government actions can have an impact on the availability of medicines to patients and Lilly's ability to invest in innovation. Through our policy and lobbying activities, we focus on a number of key issues of concern to Lilly and our industry, including:

Affordability and Access

Lilly produces medicines to meet patients' health care needs, and we believe that it is critical for patients to have access to our products, which save and improve lives. Access to medicines is a function not only of price but of health care coverage, particularly in the United States. For this reason, Lilly supports finding ways to increase the availability of affordable health insurance for all.
Lilly recognizes the importance of containing rising health care costs triggered by aging populations, increased public expectations of the health care industry, and in some countries, the need to meet budgetary restrictions and/or reduce budget deficits. We believe that innovative pharmaceuticals are part of the solution to - not the cause of - this problem. Governmental efforts to reduce drug access and prescribing are not effective and ultimately hurt patients. Simply put, they shift costs to other components of the health care system. Pharmaceuticals, when properly integrated with other methods of treatment, lead to lower overall health care costs.
The research-based biopharmaceutical industry is uniquely qualified to discover, develop, and produce lifesaving innovative medicines for patients who need them. Measures to artificially control industry growth and drug prices are counterproductive to that effort. Government-mandated restrictions reduce the return on investment needed by biopharmaceutical firms to engage in the costly research and development of new cost-effective products. The competitive market forces that exist in the biopharmaceutical industry are the best insurance against excessive drug prices and a key driver of continued discovery and development of innovative drugs that help patients. We believe that integrated, private-sector coverage for drugs is the best way to ensure access by all patients to the miracles of modern medicines.

U.S. Health Care Reform

Lilly supports access to affordable, private health care coverage for all Americans.
With a diverse population of more than 300 million people, all with individual needs, there is no single solution for health care reform in the United States.
Effective health care policy is contingent on a balance between access, quality, and cost.
Lilly supports health care reform packages that extend health care access to those who currently lack it while preserving or improving access for those who have it today. This includes improving outreach to enroll individuals in public programs for which they are eligible.
Lilly prefers free-market solutions over government-managed systems. Giving Americans the same tax benefits whether they purchase health care coverage individually or through their employer, enacting medical liability reforms, and expanding Health Savings Accounts (HSAs) and other consumer-directed coverage models, would encourage participation in the health care system.
Lilly supports patient-centered practices that enable individuals, along with their physicians and health care providers, to make informed choices regarding their health care. Health insurance benefit designs should foster the physician-patient relationship and recognize the essential role of prescription medicines and other innovations in providing cost-effective health care.
Lilly does not support single-payer systems. These government systems have been given numerous chances to work in other nations, and evidence suggests they are far from ideal. Single-payer systems restrict access, ration care, eliminate competition, and hinder quality improvements by limiting innovation.
The government's role should be primarily one of financial and administrative support for the health care infrastructure, e.g., subsidizing and facilitating standards for rapidly implementating of medical information technology, setting quality standards, and supporting a safety net.
Lilly Principles for U.S. Health Care Reform include:
- Principle 1: Lilly supports reforms that protect and encourage patient choice in the management of their health and the health of their families.
- Principle 2: Lilly supports health care reforms that enable patients as responsible participants in their health, while requiring accountability to patients by all participants in the health care arena – including insurers, health care providers (HCPs), payers, regulators, and innovators.
- Principle 3: Lilly supports health care reforms that protect and promote free-market competition by rewarding providers and innovators based on quality and value provided to the patient.
- Principle 4: Lilly supports reforms to U.S. health care that improve the quality and efficiency of health care delivery, thus reducing waste and system costs.

Integrated Health Care Systems

In keeping with our commitment to provide customers with effective results and lower costs, Lilly encourages the transition from the current component-based health care system to a comprehensive integrated health care delivery system. The traditional approach of trying to control costs of each treatment element ignores the fact that limitations on one element may lead to increased patient morbidity or mortality, resulting in an increase in total health care costs.
For example, while a new drug may cost more than an older one, the benefits of the new therapy may far outweigh this increased expense by eliminating other expenses, such as hospitalization. We believe that the best approach to treatment is to consider the whole patient and to use whatever combination of interventions and therapies is most likely to produce optimal clinical and economic results. No element of the health care delivery process can work alone.

Comparative Effectiveness

The Medicare Modernization Act of 2003 (MMA) commissioned the Agency for Healthcare Research and Quality (AHRQ) to conduct comparative clinical effectiveness (CCE) reviews.
Lilly believes that patients, physicians, and other stakeholders in the health care system should have access to objective, scientifically-based, and relevant information on the comparative clinical effectiveness of different diagnostics, therapies, procedures, health care delivery processes, and health policies in specific patients and populations. The evidence should be based on sound comparative research that is interpreted objectively, considering the inherent limitations of such studies and the need to recognize the potential differences across populations.
In addition, Lilly believes there is an opportunity to evaluate health benefit design through comparative research, as benefit design plays a significant role in the health care delivery process (e.g. the impact of a tiered benefit structure on patient access and overall health outcomes).
An inclusive and vibrant CCE research community, including academic centers, private health plans, pharmaceutical and device companies, hospitals and other providers, and other qualified research bodies, can create improved standards of care and better quality outcomes for patients.
CCE research must not be used merely as a policy instrument for cost control that limits access to appropriate individual needs-based care for patients.

Follow-On Biologics

There is a spectrum of complexity among biologic molecules and their manufacturing processes that determines whether, and to what degree, abbreviated approval requirements for Follow-On Biologics (FOBs) are scientifically feasible.
Lilly believes any legislation that would create a new regulatory pathway to authorize FOBs should protect patient safety and product integrity, respect proprietary information, and contain intellectual property provisions that help ensure the research and development of innovative, lifesaving biologic products.
FOB approval standards, including clinical trials and manufacturing requirements, must be sufficiently rigorous for both pioneer and follow-on versions of biologic products to assure that the patient will receive a safe, pure, and potent product.
The important differences between a pioneer biologic and a FOB should be transparent so that health care providers and their patients can make the decision as to which medicine is best for them.

Intellectual Property

Lilly supports strong and effective protection of intellectual property rights, including patent protection for pharmaceutical products. The pharmaceutical industry is dependent upon this protection, which grants the inventor of a new product an exclusive, yet limited, period to develop and market the product. Without this protection, pharmaceutical research companies would not be able to recoup the approximately $800 million to $1.3 billion that they invest, on average, to discover and develop each new drug. Lack of strong intellectual property rights would have a chilling effect on the industry's ability to bring new lifesaving drugs to patients around the world.
Lilly recognizes the importance of international efforts that seek to improve and harmonize intellectual property protection throughout the world. We continue to support international trade agreements that facilitate the implementation of effective patent protection for pharmaceutical products in important markets that formerly provided inadequate protection. Lilly also recognizes the significant contributions that U.S. trade laws and the World Trade Organization (WTO) rules have made in the area of intellectual property protection. We support their continued use to encourage developing countries to provide effective patent protection for pharmaceutical products. Adherence to WTO standards of intellectual property protection stimulates economic growth (through increased investment and retention of local talent) and ensures the availability of innovative medicines.

Importation

Legalizing the importation of prescription drugs will not result in significant savings for government or private payers or consumers.

Over the last few years a number of bills have been proposed that would legalize the commercial and personal importation of unapproved prescription drugs from foreign countries as a way to obtain cheaper medications. However, legalizing the importation of prescription drugs will not result in significant savings for government or private payers or consumers. European countries have seen very little cost savings with legalized importation, and the U.K. (one of the largest importers) has seen less than 2 percent savings.
Legalizing the importation of prescription drugs will also import foreign price controls and have a negative effect on the development of new medicines.
Most importantly, Lilly understands that the importation of prescription drugs will put U.S. patients at risk of receiving counterfeit or otherwise adulterated products.

Medicare Part D – Non-Interference

The non-interference provision of the Medicare Prescription Drug, Improvement, and Modernization Act bars the Secretary of Health and Human Services from interfering with the negotiations between drug manufacturers, pharmacies, and sponsors of prescription drug plans, or from requiring a particular formulary or price structure for covered drugs.
Many leaders in business and government understand that this provision is central to allowing the private sector to effectively contain costs, while others have attacked the provision and believe that the government should use its buying power to attempt to control spending. A number of bills have been introduced since the Medicare Modernization Act was passed in December 2003 that would repeal or amend this provision.