Public Policy

Public policy is used by the government to create order or to look into the issues that are affecting the citizens of the United States. They are carried out through following guidelines that are indicated in the constitution. A policy is not a tangible thing but rather, public policy is used to describe a set of laws, regulations, and mandates. They are made through a political process. This legal process helps the government be able to create laws that serve a great purpose to citizens. (John, 2013). In healthcare with stem cell research public policies are implemented to achieve specific health care goals, build consensus and inform people (Who,int.2019).

A policy established and carried out by the government goes through several stages from inception to conclusion. These are agenda building, formulation, adoption, implementation, evaluation, and termination (Birkland, 2014).

Before a policy can be created, a problem must exist that is called to the attention of the government. Specific events can place a problem on the agenda. The next stage, Policy formulation means coming up with an approach to solving a problem. Congress, the executive branch, the courts, and interest groups may be involved. Contradictory proposals are often made. The president may have one approach to stem cell research funding, and the opposition-party members of Congress may have another. Policy formulation has a tangible outcome: A bill goes before Congress or a regulatory agency drafts proposed rules. The process continues with adoption. A policy is adopted when Congress passes legislation, the regulations become final, or the Supreme Court renders a decision in a case (Birkland, 2014).

The implementation or carrying out of policy is most often accomplished by institutions other than those that formulated and adopted it. A statute usually provides just a broad outline of a policy. Successful implementation depends on the complexity of the policy, coordination between those putting the policy into effect, and compliance (Birkland, 2014).

Evaluation means determining how well a policy is working, and that is not always an easy task. History has shown that once implemented, policies are difficult to terminate. When they are terminated, it is usually because the policy became obsolete, clearly did not work, or lost its support among the interest groups and elected officials that placed it on the agenda in the first place (Birkland, 2014).

Another component of policy formation is the role of interest groups. According to Hill and Varone (2014), interest groups can influence the process in ways such as lobbying government. This is where these interest groups can hire representatives to advocate for interests that the group has. They also engage themselves in election activities where they influence people to support and vote for individuals that are concerned with their interests. Citizens influence the process by focusing on issues that affect the public at large. They mainly focus on environmental and social issues. Due to their large numbers, they are able to hire lobbyists. They use tactics such as litigation and electioneering. Another tactic is the ability to mobilize citizens towards their cause and this is possible due to their large numbers (Hill & Varone, 2014).

Stem cells have been used in medicine since the 1950’s when bone marrow transplants were first used to treat leukemia. Congressional involvement in stem cell policy started as early as 1974. The first major amendment related to the use of federal funds for research involving embryonic stem (ES) cells occurred in 1996.

In 1996, Congress banned federal funding for research on embryos through the Dickey-Wicker Amendment, named after Reps. The amendment prohibited the use of federal funds for the creation of a human embryo or embryos for research purposes, or research in which a human embryo or embryos are destroyed, discarded or knowingly subjected to risk of injury or death greater than that allowed for research on fetuses in utero. In August of 2000, The National Institute of Health interpreted the amendment and released guidelines and stipulations in order to conduct research.

In 2001, President George W. Bush prohibits the federal funding of any research using ES cell lines derived after August 9, 2001, but his policy does not affect research in the private sector or research conducted with state funding. The President claims that more than 60 stem cell lines are still available for funding. Research on adult stem cells is not affected by this executive order.

In 2005 H.R. 810, to expand federal funding for stem cell research passed both the House and the Senate in the 109th Congress, attracting bipartisan support. However, the bill is quickly vetoed by President Bush. The House votes 235-193 in favor of the bill, but the two-thirds majority needed to override the veto is not reached.

In 2007, the 110th Congress, the Senate passes their version of The Stem Cell Research Enhancement Act (S. 5) with strong bipartisan support, 63-34. The House also passes the Senate’s version of the bill 247-176. Again, the bill is vetoed by President Bush, and again Congress cannot override the veto.

On March 9, 2009, President Barack Obama issued an Executive Order lifting restrictions on the federal funding of human embryonic stem cell research that had been in place since The Obama Executive Order directed the National Institutes of Health to issue Guidelines to permit such funding. The NIH finalized its stem cell Guidelines on July 7, 2009.

Shortly after the NIH Guidelines were in place, James L. Sherley, M.D., Ph.D., (Boston Biomedical Research Institute) and Theresa Deisher, Ph.D., (Ave Maria Biotechnology Company) filed suit (Sherley v. Sebelius) in federal court challenging the Guidelines and the federal funding of hESC research. The plaintiffs alleged that the Guidelines violate the so-called Dickey-Wicker provision that has appeared in every Labor-HHS appropriations bill since 1996. That provision prohibits federal funding for research in which embryos are created for research purposes, or in which human embryos are destroyed, discarded or subject to risk.

On August 23, 2010, U.S. Federal District Court Judge Royce C. Lamberth issued a temporary restraining order immediately prohibiting the NIH from further funding human embryonic stem cell (hESC) research. Judge Lamberth’s order came following a Federal Appeals Court decision giving Sherley and Deisher standing to bring their suit. Judge Lamberth ruled that the plaintiffs were likely to win their case when it came to trial.

The U.S. Court of Appeals for the D.C. Circuit stayed the preliminary injunction pending appeal and on April 29, 2011, a split three-judge panel lifted the preliminary injunction. The majority opinion concluded that the opponents of hESC “are unlikely to prevail because Dickey-Wicker is ambiguous and the NIH seems reasonably to have concluded that, although Dickey-Wicker bars funding for the destructive act of deriving an ESC from an embryo, it does not prohibit funding a research project in which an ESC will be used.” Federal District Court Judge Royce Lamberth on July 27, 2011, rejected the claims of the plaintiffs and dismissed their suit. Judge Lamberth’s decision closely tracked the decision of the U.S. Court of Appeals panel that ruled on the appeal of his preliminary injunction.On August 23, 2012, in a decision favorable to proponents of ES cell research, the U.S. Court of Appeals for the D.C. Circuit upheld a lower court ruling dismissing a lawsuit that challenged the Obama administration’s expansion of federal funding ES cell research.

The Supreme Court declined to hear the appeal in an announcement on January 7, 2013. The announcement allows the decision of the appeals court to stand.

Many congressional members in the House and Senate seek to codify the stem cell rules established under President Obama’s executive order, preventing future administrations from unilaterally restricting or eliminating federal funding for stem cell research. Bills such as the Stem Cell Research Advancement Act, which would permit funding for research on stem cells derived from embryos produced but ultimately not used for in vitro fertilization, have been regularly introduced in the House and Senate since 2009, but no legislation has been enacted.

In 2013 The Supreme Court announces that it will not hear Sherley v. Sebelius, thereby upholding the previous ruling of the D.C. Circuit Court’s ruling. “This is a major victory for scientifically and ethically responsible innovative research,” Bernard Siegel, spokesperson for the Stem Cell Action Coalition and executive director of the Genetics Policy Institute, says in a statement.

Also in 2013 President Obama signed the 21st century cures act into law. The 21st Century Cures Act includes provisions intended to assure timely regulatory review of regenerative therapies, including cell therapies enabled by stem cell therapy research.

Stem cell research has been particularly important in advancing the field of “regenerative medicine,” which focuses on replacing, engineering or regenerating cells, tissues and organs in order to achieve normal function. Over the past several years, there has been a heightened focus on ensuring the Food and Drug Administration (FDA) is equipped to properly and efficiently review the safety and effectiveness of the treatments arising from this rapidly evolving category of medicine.

Fast forward to 2018 President Trump has also endorsed making life-saving treatments like stem cell therapies more available to more Americans voicing his clear support for “Right to Try” legislation, which would increase the medical options of the critically ill by helping them avoid the unduly burdensome and bureaucratic spider’s web of the FDA.

The language of the Right to Try legislation is simple, straightforward and offers protections for patients and manufacturers. Under the Senate version, an “eligible patient” who has been diagnosed with a terminal illness may be prescribed an experimental drug or biological product to treat their illness, so long as the patient has a qualified physician certify that he or she has exhausted all other treatment options and is unable to participate in a clinical trial. The patient must also provide informed consent to the physician and the physician may not be compensated by the manufacturer of a treatment for certifying the patient. The patient, physician and manufacturer must all agree on the treatment.

In 2018 an overwhelming and increasingly rare bipartisan display (94-1), the Senate has already passed the Right to Try Act. The House version is currently awaiting approval.

References:

1. Who.int. (2019). WHO | Health policy. [online] Available at: https://www.who.int/topics/health_policy/en/ [Accessed 1 Mar. 2019].
2. John, P. (2013). Analyzing public policy. Routledge.
3. Birkland, T. A. (2014). An introduction to the policy process: Theories, concepts, and models of public policy making. Routledge.
4. Hill, M., & Varone, F. (2014). The public policy process. Routledge.
5. University of Wisconsin-Madison. “”Twenty years on, measuring the impact of human stem cells.”” ScienceDaily. ScienceDaily, 1 November 2018. .
6. https://www.researchamerica.org/advocacy-action/issues-researchamerica-advocates/stem-cell-research
7. https://www.aamc.org/advocacy/research/74440/embryonicstemcellresearch.html