Assignment:
Ethics and Corporate Responsibility in the Workplace and the World
PharmaCARE (We CARE about YOUR health®) is one of the world's most successful pharmaceutical companies, enjoying a reputation as a caring, ethical and well-run company that produced high-quality products that saved millions of lives and enhanced the quality of life for millions of others. The company offers free and discounted drugs to low-income consumers, has a foundation that sponsors healthcare educational programs and scholarships, and its CEO serves on the PhRMA board. PharmaCARE recently launched a new initiative, We CARE about YOUR world®, pledging its commitment to the environment through recycling, packaging changes and other green initiatives, despite the fact that the company's lobbying efforts and PAC have successfully defeated environmental laws and regulations, including extension of the Superfund tax, which was created by Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA).
Based in New Jersey, PharmaCARE maintains a large manufacturing facility in the African nation of Colberia, where the company has found several "healers" eager to freely share information about indigenous cures and an abundance of Colberians willing to work for $1.00 a day, harvesting plants by walking five (5) miles into and out of the jungle carrying baskets that, when full, weigh up to fifty (50) pounds. Due to the low standard of living in Colberia, much of the population lives in primitive huts with no electricity or running water.
PharmaCARE's executives, however, live in a luxury compound, complete with a swimming pool, tennis courts, and a golf course. PharmaCARE's extensive activities in Colberia have destroyed habitat and endangered native species. Two (2) years ago, after PharmaCARE's research indicated that one of its top-selling diabetes drugs might slow the progression of Alzheimer's disease, its pharmacists began reformulating that drug to maximize the effect. In order to avoid FDA scrutiny, PharmaCARE established a wholly-owned subsidiary, CompCARE, to operate as a compounding pharmacy to sell the new formulation to individuals on a prescription basis. CompCARE set up shop in a suburban office park near its parent's headquarters, and to conserve money and time, did a quick, low-cost renovation and designated Allen Jones to run the operation's "clean room."
CompCARE benefited from PharmaCARE's reputation, databases, networks, and sales and marketing expertise, and within six (6) months had the medical community buzzing about AD23. Demand soared, particularly among Medicare, Medicaid, and VA patients. Seeing the opportunity to realize even more profit, CompCARE began advertising its services and the availability of AD23 to consumers and marketing the drug directly to hospitals, clinics, and physician offices, even though compounding pharmacies are not supposed to sell drugs in bulk for general use. To get around this technicality, CompCARE encouraged doctors to fax in lists of bogus patient names.
Introduction
The company offers free and discounted drugs to low-income consumers, has a foundation that sponsors healthcare educational programs and scholarships, and its CEO serves on the PhRMA board. Pharma CARE recently launched a new initiative, We CARE about YOUR world®, pledging its commitment to the environment through recycling, packaging changes and other green initiatives, despite the fact that the company's lobbying efforts and PAC have successfully defeated environmental laws and regulations, including extension of the Superfund tax, which was created by Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA). Based in New Jersey, PharmaCARE maintains a large manufacturing facility in the African nation of Colberia, where the company has found several "healers" eager to freely share information about indigenous cures and an abundance of Colberians willing to work for $1.00 a day, harvesting plants by walking five.
A new U.S. law requires pharmaceuticals to be tracked and secured across the healthcare supply chain. Pharmaceutical supply chain leaders must re-evaluate their current and future track-and-trace strategies now. The ethics committee of clinical research or Institutional Review Board (IRB) is defined as an independent body (a review board or a committee, institutional, regional, national, or supranational), constituted of medical/scientific professionals and nonmedical/nonscientific members, whose responsibility it is to ensure the protection of the rights, safety, and well-being of human subjects involved in a trial and to provide public assurance of that protection, by, among other things, reviewing and approving/providing favorable opinion on the trial protocol, the suitability of the investigator(s), facilities, and the methods and material to be used in obtaining and documenting informed consent of the trial subjects. (Perez, 2010)
The legal status, composition, function, operations, and regulatory requirements pertaining to IECs / IRBs may differ among countries, but should allow the IECs / IRBs to act in agreement with good clinical practice (GCP).
Event
On 28 November 2013, U.S. President Barack Obama signed H.R. 3204 - the Drug Quality and Security Act (DQSA) - into law. The law calls for the U.S. Food and Drug Administration (FDA) to set standards for tracking and tracing pharmaceuticals, and phases in requirements for specified trading partners across the U.S. healthcare supply chain. It requires manufacturers of pharmaceuticals sold in the U.S. to:
· Begin capturing and reporting product transaction histories by 1 January 2015.
· Implement systems to report suspect or illegitimate products by 1 January 2015.
· Serialize individual products by 2017.
Cost analysis of clinical trial review by ethics committees
Institutional review boards (IRB) independent ethics committees (IEC), or ethics review boards (ERB)) are formal groups of professionals designated to review and monitor research involving human subjects. The IRB provides critical review and oversight for research and has the authority to approve, require modifications or disapprove research. The main function of the IRB is to assess the scientific, ethical, and regulatory aspects of a trial, in order to protect the rights and safety of study participants.
The structure and PharmaCARE of the independent ethics committees (IEC) or Institutional Review Boards (IRB) varies from one country to another but nearly all require payment to be made to review the clinical trial protocol and any amendments that are required to be made to the protocol.
Analysis
This law is a positive step for securing the U.S. pharmaceutical supply chain and has encouraging implications for the industry globally. The DQSA removes uncertainty around governance, enabling manufacturers to move forward with investments and serialization deployments with increased confidence. Pharmaceutical manufacturers can begin to make decisions to ensure traceable electronic records of custody for their manufactured products. This tracking will protect their revenue streams against the risk of counterfeited products.
The law provides the FDA with the authority to oversee all nodes of U.S. pharmaceutical supply chains for the first time. It sets out staggered compliance timelines for manufacturers, repackagers, third-party logistics providers, wholesalers, distributors and pharmacies. The law will offer the potential for a more network-centric approach to track and trace, and more flexibility in compliance.
The law will require the phased implementation of standardized numerical identifiers on a 2D data matrix bar code. This requirement is consistent with identifier trends in Europe, China and many other countries. The law proposes guidance on standards for the interoperable exchange of transactional data as well as governance for potential waivers and enhanced packaging security measures.
The DQSA may also help shape global standards, bringing further direction to a diverse patchwork of national and geographic regulations. In particular, China and Europe have proactively centered deployment models around track and trace, and verification, respectively. Due to the high maturity of deployments in these regions, they are likely to influence emerging global standards and best practice adoption.
Fees for assessment of clinical trial applications by research ethics committees in the principal Asian countries
India
The DGCI provides approval in 12 weeks from the date of submission. After the dossier is submitted to the regulatory authorities, parallel submission is made to the respective ethics committees of the potential sites, which are individual research centers. Many hospitals (including government and private facilities) also have Scientific Review Committees (SRC) to review the scientific rationale of the study for better safety and the well being of trial patients. Once the study is approved by the SRC the study is then submitted to the ethics committee for their review and approval.
There are now more than 300 institutions in India with Ethics committees, which follow the ICH-GCP, and Schedule Y of the Drugs and Cosmetic Act of 1945. The composition of Indian IRBs is also similar to those in other markets. The typical number of members is around five to seven people, with a maximum range of 12 to 15. Members typically include individuals from the local medical and nonmedical community. The average ethics committee approval time line is 4 to 6 weeks depending upon the meeting schedule and workload. (Eldabi, 2011) The average IRB/ethic committee fee for reviewing the documentation in India is INRs 30,000 ($640).
China
Before a clinical trial can proceed in China it must be approved by a hospital's ethics committee. Typically each site which is approved to conduct a clinical trial in China has an ethics committee. Each one has its own timelines and despite the formalities, the process has been described locally as little more than a rubber-stamping exercise. The ethics committee setup in China tends to not follow the pattern of those in Western countries. At present, many of those who serve on ethics committees at Chinese hospitals are medical doctors from the same hospital. (Simonet, 2010)
Today the Internet features a vast number of interconnected systems with disparately managed digital identities. However, it has become clear to most individuals, governments and enterprises that the current condition has led to some inconvenience for consumers, who must manage an ever-growing number of credentials and passwords. Identity proofing and authentication security efforts are implemented inconsistently, are always under attack, and are not enough by themselves to reduce online fraud. (IDC, 2011)
Variable legacy technology environments and identity assurance requirements, lack of trust among potentially participating entities, liability concerns and competing standards have all contributed to this increasingly visible set of problems related to using digital identities for online interactions.
Pharmaceutical manufacturers and downstream trading partners:
- Start or continue initiatives for serialization. Phase deployments well in advance of U.S. and other global initiatives with earlier compliance timelines (such as China).
- Shift the focus of compliance efforts from item-level serialization to lot-level transaction capture and reporting with a target of January 2015.
- Develop an architecture design for track and trace that accommodates the production and tracking of serialized and nonserialized products simultaneously.
- Define a migration path to move to either point-of-dispense authentication or full track and trace built on item-level serialization.
- Favor providers with experience in e-pedigree management and compliance reporting, preferably in a cloud-based environment or similar capability to support interoperability networks.
- Consider enterprise solutions based on emerging global standards. Do not overstandardize at the expense of performance or compliance.
- Think beyond compliance. Collaborate with partners to enforce the business case and strategy for track-and-trace capabilities by enhancing existing architecture and processes.
Key Findings
The strategy identifies current issues that hinder an efficient, trusted, interoperable identity environment. It recommends actions to change current policies, and regulations, practices and technical approaches to bring about a desired future state. However, even if the government succeeds in doing its part, the changes will not be enough.
The business value of an improved identity ecosystem is overstated, and the strategy does not have a timeline for execution, nor does it sufficiently address the different businesses and risk profiles inherent to specific communities of interest that are major root causes for the current situation and major impediments to improvements. (IDC, 2011)
Recommendations
Relying parties that protect sensitive data and conduct transactions will need to continue to ensure that the appropriate controls are in place, and they should not expect a generally available identity ecosystem to support these requirements for five or more years.
Relying parties should expect to continue paying directly for identity assurance services, rather than getting these services from public identity providers that serve consumers directly.
Potential identity providers should pursue business opportunities with individual government and enterprise relying parties or well-organized communities of interest, rather than expecting consumers to drive demand.
Identity is just one piece of the security puzzle
The strategy recognizes that "trusted identities are one part of layered security and that online security will not be achieved through the establishment of an identity ecosystem alone." Numerous other information security efforts affect the security of online transactions. ... The identity ecosystem must be developed in parallel with national efforts to improve platform, network, and software security."(B2B, 2011)
The document leaves the treatment of these other security requirements mostly out of scope and references other government security initiatives. Indeed, overall improvements to identity assurance are needed, but they are just one aspect of securing online transactions. We know that attackers have been able to circumvent identity assurance practices - particularly identity proofing and authentication. Thus, even if the strategy vision is fulfilled, relying parties -especially those parties holding sensitive data and conducting financial transactions - will need to continue to use other security controls to reduce thefts.
Another significant factor in adoption is related action by the U.S. Food and Drug Administration (FDA) to establish a rule (which Congress had directed it to do in 2007 legislation) that most medical devices distributed in the U.S. carry a unique device identifier (UDI). The FDA cited its benefits in improving the quality of information in medical device adverse event reports and improving patient safety by helping the FDA identify product problems more quickly and more effectively target recalls.
The Global Harmonization Task Force, a voluntary group of representatives from national medical device regulatory authorities and the regulated industry, supports these interests by encouraging international harmonization in the regulation of medical devices. Although this future use is not included in our assessment of GS1 Healthcare position and adoption speed, the UDI is dependent on something like the GDSN operating, and UDI code would be according to ISO 15459 (issuing agencies GS1, Health Industry Business Communications Council and the International Council for Commonality in Blood Banking Automation). Interested parties should keep abreast of the pending/overdue final rule from the FDA on the UDI and review of approximately 300 comments received. Note that GS1 Healthcare is part of the World Health Pharma CARE International Medical Products Anti-Counterfeiting Taskforce (IMPACT).
An important endorsement occurred in April 2013 when the Healthcare Transformation Group (made up of Geisinger Health System, Intermountain Healthcare, Kaiser Permanente, Mayo Clinic and Mercy, which has been acting in support of GS1 standards for some time) announced the establishment of an R&D team of physicians and clinical researchers to advance the adoption of GS1 standards and jointly accelerate the health systems work to implement a UDI system. Their work includes establishing a standard language and network of datasets and an expansion of an FDAUDI demonstration project currently underway.
Clinical technology has long played a role in reducing the cost of a clinical study, but clinical study complexity and regulatory risk management have outpaced innovations. Study complexity has been driven by the number of data points captured, recruiting challenges, redundancy of data collection and sharing efforts, and so on. Regulatory risks are driven by safety concerns, validation, data sourcing and concerns about the risk of innovating.
But clinical technology is maturing, making greater use of analytics, and a new focus on business process improvement is taking root. New business models will focus on the services and outcomes needed, not the technology; sponsor efforts will focus on major decision points, not operational activities; and planning/analytics improvements will substitute insight for operational costs. Adaptive trials, remote and risk-based monitoring, targeted recruiting, standard investigator portals and source data capture will become process realities. As supporting technology and its related standards mature, are delivered on the cloud, and become focused by study type (such as Phase 3 or Phase 4 oncology) and connected to electronic health record (EHR) systems, their ability to support these new business models multiply.
Key Findings:
As the number of information sources proliferates around the globe, the challenge of understanding customer needs, identifying safety concerns and connecting with "real" consumers of their products is becoming increasingly complex. Undaunted by the complexity, many life science companies are pursuing strategies to buy channel-based specialty tools that focus on a single data source, such as monitoring social media or identifying safety concerns from nontraditional sources that elicit complaints. As companies do this, they realize that their solutions lack durability and adaptability as technology and information sources change. Global listening tools will emerge that will fill the need to track many sources on a global basis, leverage the efficiency of the cloud's shared infrastructure model, provide the platform for analytics support and create the agility to change.
Market Implications:
As the market for monitoring the "world of big data" matures and shifts from a specialty model to a more comprehensive sourcing and services model, sourcing of needs will shift from a fad basis to a durable basis, with services being a major component. Technology providers that come and go as information sources come and go will experience consolidation. The beneficiaries will be the more traditional content providers and integrators, with broad views of business needs and scale, that provide continuity to their customers. Expect the capabilities to evolve from accessing data to sophisticated monitoring and screening technology that can understand SMS text, Web sources, video, audio and traditional structured data.
References:
· Victor W. Perez (2010), The rhetoric of science and statistics in claims of an autism epidemic, in Ananya Mukherjea (ed.) Understanding Emerging Epidemics: Social and Political Approaches (Advances in Medical Sociology, Volume 11), Emerald Group Publishing Limited, pp.203-221
· Kirandeep Chahal, Tillal Eldabi, (2011) "Hybrid simulation and modes of governance in UK healthcare", Transforming Government: People, Process and Policy, Vol. 5 Iss: 2, pp.143 - 154
· Daniel Simonet, (2010) "Healthcare reforms and cost reduction strategies in Europe: The cases of Germany, UK, Switzerland, Italy and France", International Journal of Health Care Quality Assurance, Vol. 23 Iss: 5, pp.470 - 488