The Healthcare Industry

THE
HEALTHCARE
INDUSTRY
Prepared by:
MA. SOPHIA P. ANDRES, RPh
DEFINITION OF TERMS
Health:
A complete state of physical, mental and social
well-being
Illness:
A person’s own perception of how he or she feels
Disease:
A judgment of one’s state of health by a medical
professional
DEFINITION OF TERMS
Health care:
 Any helpful activity intended to maintain or improve health
 The provision of health care to persons in need is done
through a variety of products (pharmaceuticals, diagnostics,
laboratory devices, surgical instruments, medical
disposables, and so on), and services, which are commonly
classified as preventive, acute, chronic, restorative, and
palliative.
 The settings of health care provision can be diverse and are
categorized in five large segments, namely hospitals,
subacute, long-term, or ambulatory care facilities, as well as
patient homes.
OVERVIEW OF HEALTH CARE
SYSTEM
SYSTEM
 System Components:
 Primary Providers:
 Facilities and individuals directly involved in treating people in need, that is,
hospitals, other healthcare facilities, and physicians.
 Recipients of their services are not only patients, but also “healthy patients,” such
as people receiving immunizations, regular check-ups, women in delivery, etc.
 Secondary Providers:
 Organizations or individuals providing resources needed for integrated health care.
 Examples:
 Reimbursement funds provide treatment funds coming from the state’s financial
chest
 Insurance companies cover expenses via proactive patient contributions
 Employers contribute resources for keeping their labor forces healthy
SYSTEM
INTERCOMPONENT
RELATIONSHIPS
HEALTH CARE REFORM
Health Care Reform:
 A governmental policy that affects health care delivery in a given
place.
 It typically attempts to:
 Broaden the population that receives health care coverage through either
public sector insurance programs or private sector insurance companies
 Expand the array of health care providers consumers may choose among
 Improve the access to health care specialists
 Improve the quality of health care
 Give more care to citizens
 Decrease the cost of health care
HEALTH CARE REGULATION
 Health Care Regulation:
 A set of procedure that helps the health care professionals to deliver
their full services to patients especially during spreading of disease
while it is endemic so that they could prevent the disease from
becoming epidemic or pandemic.
MAJOR INTERNATIONAL
REGULATORY BODIES
U.S. Food and Drug Administration
 Historical Milestones:
 1862: Bureau of Chemistry (within the Department of Agriculture)
set up by President Lincoln
 1902: Biologics Act
 1906: Federal Food and Drug Act
 1938: Food, Drug and Cosmetics Act required new drugs to be safe
before marketing
 1962: Kefauver-Harris Amendments required U.S. drug manufacturers
to show their product’s effectiveness and safety before marketing
 1976: Medical Device Amendments
 1997: Modernization Act
INVESTIGATIONAL NEW
DRUG (IND) APPLICATION
 Contents of application:
1. Sponsor and trial monitor names
2. Commitment for not starting the trial before the application is
approved
3. Commitment that the institutional review board (IRB) and the
sponsor will comply with all relevant FDA guidelines
4. Investigational plan
5. Investigator’s brochure
6. Trial protocol
7. Chemical, manufacturing, and quality assurance data
8. Pharmacological and toxicological data
9. Marketing experience data
PHARMACEUTICAL REGULATION
ORGANIZATION OF THE FDA
FDA RESPONSIBILITIES
THREE MAJOR TYPES OF IND
 Treatment:
 A drug intended for serious/life-threatening disease, with no satisfactory
alternatives.
 The drug must already be in controlled clinical trials.
 The sponsor must be actively pursuing an FDA approval.
 Compassionate:
 Submitted by a single investigator, for a single (named) patient.
 Named Patient:
 Required for importing a small quantity of a drug registered for this
indication into another country.
 Emergency:
 Used in life-threatening diseases, with no existing alternatives (e.g. AIDS).
 FDA authorizes the drug shipment before IND submission.
NEW DRUG APPLICATION
(NDA) APPROVAL
Following the completion of all required clinical
trial stages, pharmaceutical manufacturers apply
to the FDA for a marketing authorization license,
using the NDA procedure.
Applications may eventually lead to an agency
decision letter announcing its:
Approval
Request for Additional Studies
Termination
MAJOR INTERNATIONAL
REGULATORY BODIES
European Agency for the Evaluation of Medicinal Plants
 Historical Milestones
 1952: Belgium, Federal Republic of Germany, Italy, France, Netherlands,
and Luxemburg set up the European and Coal Steel Committee (ECSC).
 1958: The European Economic Community (ECC) is formed (Rome Treaty).
 1965: First EEC Directive on medicinal drug regulation.
 1975: Analytical, pharmacotoxicological, and clinical standards and
protocols for the testing of medicinal products are created. The Committee
Proprietary Medicinal Products (CPMP) is established.
 1987: The procedure for placing high technology medicinal products,
especially biotechnological, on the market is created.
 1993: The European Agency for the Evaluation of Medicinal Products
(EMEA) is formed and based in London. The centralized approval
procedure is introduced.
 2000: Regulation 2000 describing new regulatory framework is currently
under discussion.
MAJOR INTERNATIONAL
REGULATORY BODIES
 Japan Ministry of Health and Welfare (Kosheisho)
 Historical Milestone:
 1946: The Kosheisho was formed following World War II. Responsible for all
aspects of pharmaceutical regulation, it requires all new drug regulatory
submissions to contain data on population of Japanese patients.
 1967: Development of “Basic policies for approval to manufacture drugs.”
 IND Procedure:
 A clinical trial application is submitted to the Inspection and Guidance
Division, Pharmaceutical and Medical Safety Bureau, Ministry of Health
and Welfare (MHW). Trials on native Japanese patients were previously
required for approval.
 NDA Procedure:
 Two Types of Product Licenses:
 Shonin: Product approval for efficacy and safety
 Kyoka: License to handle the shonin-approved product based on personnel and
facilities qualification
REFERENCES
 Smith R (ed.) Medical journals and pharmaceutical companies: uneasy
bedfellows. BMJ 2003;326:1202–1205.
 Pharmaceutical Research and Manufacturers of America. Code on
Interactions with Healthcare Professionals, July 2002 (
www.phrma.org/code_on_interactions_with_healthcare_professionals).
 The Association of British Pharmaceutical Industry. Code of Practice,
2006 (www.abpi.org.uk/publications/pdfs/pmpca_code2006.pdf).
 World Health Organization. Criteria for Medicinal Drug Promotion.
Geneva: WHO, 1985 (
www.who.int/medicinewww.fda.gov/cder/ddmac/docs/collect/edmweb/
pdf/whozip08e/whozip08e.pdf
).

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