强生制药公司课件

1、the pharma, biotech and device colloquiumcompliance pre-conference workshopmonday, june 6, 2005louise mehrotravp ww health care compliancejohnson & johnson a primer on compliance programs for pharmaceutical and medical device companieskathy lundbergsvp/chief compliance officerguidant corporation

2、强生制药公司3 2004 sales of $47.3 billion over 200 operating companies in 57 countries around the world leadership positions in ethical and otc pharmaceuticals, medical/surgical supplies, diagnostics and a variety of consumer products broad based, diverse portfolio of productsworlds most comprehensive and

3、 broadly based health care company强生制药公司4by geographic areaworldwide net trade sales2004u.s.europew. hem (ex. us)asia pacific & africa12%5%24%59%$47.3 billion强生制药公司52004sales by segment46.7%17.6%35.7%md&d$16.9 billionpharmaceutical$22.1 billionconsumer$8.3 billion强生制药公司6guidant corporate pro

4、file强生制药公司7guidant corporation structurecrmviescscardiac rhythmmanagementendovascularsolutionscardiacsurgeryvascular interventioncompassheadquartersgeographic operations强生制药公司8overviewwhy are compliance programs important?history and basics of the u.s. sentencing commission guidelineshhs oig complia

5、nce program guidelinescompliance program basics written standards of conduct leadership and infrastructure education and training internal communications and reporting monitoring and auditing enforcement of disciplinary standards responding to detected offensesconcluding thoughts强生制药公司9why are compl

6、iance programs important? (or who cares?)effective programs can prevent wrongdoing and lessen the damage when violations do occur.a credible compliance program can be influential at key stages of the investigative and enforcement processes: whether to continue or expand an investigation whether to t

7、urn investigatory results over to prosecutors whether to charge a company with wrongdoing whether to pursue criminal or civil charges whether to settle a case and, if so, on what terms whether to pursue exclusion or debarment of a company强生制药公司10u.s. sentencing commission guidelinesthe 1984 sentenci

8、ng reform act created the u.s. sentencing commission and directed it to develop guidelines for sentencing of individuals and entities convicted of federal crimes.sentencing guidelines for individuals were issued in 1987. the guidelines for organizations (including corporations convicted of federal c

9、rimes) were issued in 1991.effect under the guidelines: an effective compliance and ethics program is one of mitigating factors that can reduce a companys fine absence may be a reason to place a corporation on probation implementation of a program may be condition of probation强生制药公司11ussc guidelines

10、 (contd)the original guidelines defined an “effective compliance program” as having seven “elements”standards and procedures for employeesspecific high-level individual(s) must be assigned overall responsibility for compliance programexercise of due care not to delegate substantial authority to indi

11、vidualstraining and communication of standards to employees and agentsreasonable steps to achieve compliance both through auditing and monitoring programs and internal reporting systemsconsistent enforcement of disciplinary standardssteps to respond to reported misconduct and prevent future violatio

12、ns强生制药公司12ussc guidelines (contd)recent amendments (effective november 1, 2004) strengthened each of the seven elements (and arguably added a new element).among the major changes: compliance programs should be designed to reasonably prevent and detect all violations of law (not just crimes)significa

13、ntly expands responsibility of “governing authority,” including a requirement to “otherwise promote an organizational culture that encourages ethical conduct and a commitment to compliance ” requires “high-level personnel” to have ultimate responsibility for programrequires adequate resources to imp

14、lement the programextends training requirement to all levels of the organizationrequires periodic evaluation of program effectivenessadds duty to promote program conduct through incentive to existing requirement to ensure enforcement of discipline for wrongdoing强生制药公司13ussc guidelines (contd)arguabl

15、y adds new “element” a requirement to implement an on-going process to assess the risk of violations and to take steps to address such risksbolsters provisions relating to “small organizations” (defined as those with less than 200 employees) states that waiver of attorney-client privilege and work-p

16、roduct protections “is not a prerequisite to a reduction in culpability score unless such waiver is necessary in order to prove timely and thorough disclosure of all pertinent information known to the organization.” 强生制药公司14introduction to hhs oig guidelinesthe oig has issued “compliance program gui

17、dances” for 11 health care industry sectors most recently for pharmaceutical manufacturers (may 5, 2003, 68 fed. reg. 23731-43). the pharmaceutical guidance states that it “may have application to manufacturers of other products such as medical devices .” each guidance is voluntary and “represents t

18、he oigs suggestions” on how to implement a compliance program. the pharmaceutical guidance states:“the contents of this guidance should not be viewed as mandatory or as an exclusive discussion of the advisable elements of a compliance program. the document is intended to present voluntary guidance t

19、o the industry and not to represent binding standards for pharmaceutical manufacturers.”“this guide is not a compliance program. rather, it is a set of guidelines that manufacturers should consider when developing and implementing a compliance program .” 强生制药公司15hhs oig guidelines (contd)each oig gu

20、idance is organized around “seven elements that have been widely recognized as fundamental to an effective compliance program.” these “seven elements” are:implementing written policies and procedures designating a compliance officer and committeeconducting effective training and educationdeveloping

21、effective lines of communicationconducting internal monitoring and auditingenforcing disciplinary standards for wrongdoing1.responding promptly to detect programs and undertaking corrective action强生制药公司16hhs oig guidelines policies and procedureswritten policies and procedures should be developed un

22、der direction of compliance officer and distributed to all relevant employeespolicies and procedures should include: code of conduct: a high-level document that details the fundamental principles, values, and framework for action within a company. it should be brief, understandable, and cover princi

23、ples applicable to all employees. detailed policies in specific risk areas: these policies should address risk areas specific to a companys business activities, organizational structure, and regulatory requirements. while policies alone do not constitute an effective program, much of an effective pr

24、ogram flows from written standards of conduct强生制药公司17hhs oig guidelines compliance officer and committeeevery company should designate a high-level official to serve as the compliance officer. may be full- or part-time.should have access and regularly report to the board of directors and senior mana

25、gement.should have authority to effectuate change within the organization, to exercise independent judgment, and to have access to all documents and information relevant to compliance activities. 强生制药公司18hhs oig guidelines compliance officer and committeethe compliance officers primary duties should

26、 include: overseeing implementation of the compliance program reporting on regular basis to the board, ceo, and others periodically revising the program to address changing needs/activities implementing a multi-faceted education and training program ensuring that independent contractors are aware of

27、 the companys program coordinating personnel issues with human resources assisting the companys internal auditors in compliance reviews reviewing and responding to reports of non-compliance independently investigating and acting on matters related to compliance participating with counsel in self-rep

28、orting to government agencies continuing the momentum after the initial years of implementation强生制药公司19johnson & johnsonhealth care compliance frameworkeach operating company must build on the foundation of the johnson & johnson health care compliance framework and operationalize it by imple

29、menting detailed policies and procedures.a robust health care compliance program will assist each operating company in fulfilling their commitment to responsible corporate conduct.强生制药公司20johnson & johnson health care compliance program framework us international health care compliance guidance

30、us international强生制药公司2112 healthcare compliance framework operating companies1. written policies and procedures7. response to detected problems and corrective action initiatives2. assigned compliance officer & committees6. enforcement & disciplinary guidelines5. auditing & monitoring3.

31、training4. communication强生制药公司22johnson & johnson health care compliance programwritten policies and procedures framework based on the “seven elements of an effective compliance program” guidance us - safe harbors and other applicable laws / regulations / standards international guidance on key

32、interactions with health care professionals强生制药公司23johnson & johnson health care compliance programassigned compliance officer and committees chief compliance officer corporate compliance officer vp of worldwide health care compliance health care compliance steering committee hcc officer at each

33、 operating company worldwide hcc committee at each operating company强生制药公司24board committeesaudit committeemanagement development & compensationcorporate governancescience & technologycompliancegovernance at guidantlong-term commitment to board best practices强生制药公司25governance at guidantlong

34、-term commitment to board best practicesjames m. corneliuschairman of the board(non-executive) /guidant corporation nancy-ann min deparlesenior advisor / j.p. morgan partners, llc, adjunct professor / the wharton school, university of pennsylvania ronald w. dollens president, chief executive officer

35、 j. kevin moore senior vice president, strategic planning / advanced medical productions mark novitch, m.d. retired vice chairman / the upjohn company ruedi e. wger, ph.d. president, chief executive officer / aventis behring llc kristina johnson, phddepartment char. school of engineeringduke univers

36、ity 强生制药公司26governance at guidantcorporate controls discipline corporate compliance chief compliance officer (since 1995)cco reports directly to the ceo and the compliance committee of the board of directorsrobust audit and oversightquarterly updates to board committee强生制药公司27 compliance committee c

37、harterguidant compliance committee charter code of business conduct and customer relationship policies oversee implementation and future revisionsprovide oversight for development and implementation of compliance program as a leader in the industryreview status and significant compliance issuesperio

38、dically verify leading edge of compliance programwith ceo, assess performance of compliance organization/officereview management/resource commitment to compliance officecoordinate with the audit committee on compliance matters that may be significant from a financial perspective, and on matters brou

39、ght to the compliance committees attention related to auditing or accounting issues and compliance with related laws/regs 强生制药公司28hhs oig guidelines education and trainingcompanies should implement programs to educate and train employees and agents on compliance issues.training should include commun

40、icating a companys standards of conduct to all relevant employees and agents.general training should focus on the companys compliance program, written standards of conduct, and applicable regulatory requirements.specialized training should be provided to employees and agents in appropriate areas (e.

41、g., sales and marketing, etc.)强生制药公司29hhs oig guidelines education and training (contd)new employees should receive training promptly.the compliance officer should document training programs and retain attendance logs, descriptions of the compliance program, and copies of materials distributed. succ

42、essful completion of training should be made a condition of employment and adherence to training requirements should be a factor in the annual evaluation of each employee. 强生制药公司30johnson & johnson health care compliance programtraining testing and annual certification targeted to job responsibi

43、lities new employee program training on failure to comply code of business conduct trainingselected topics强生制药公司32强生制药公司33强生制药公司34强生制药公司35强生制药公司36强生制药公司37强生制药公司38 training tools on-line training management system integrated with hr system matches people in current job category to required training e

44、mail message to take training follow-up message to the boss maintains the record of training taken and date assessment test for understanding. must pass with 80% correct. tracking of training强生制药公司39hhs oig guidelines internal reporting & communicationsemployees should have access to access to s

45、upervisors and/or the compliance officer.companies should implement an internal “hotline” or similar mechanism to allow employees and others to ask questions or report potential violations of policy or law. reporting mechanisms should allow for the anonymous reporting of violations and company polic

46、y should prohibit retaliation for good faith reporting. sarbanes-0 xley added new prohibitions on retaliation in some situations强生制药公司40hhs oig guidelines auditing and monitoringcompliance programs should include mechanisms to monitor and audit compliance.compliance officers should document on-going

47、 monitoring and auditing programs. extent and frequency of compliance audits may vary according to: available resources prior history of non-compliance risk factors particular to the companycan include prospective systemic review or a retrospective review of actual practices强生制药公司41johnson & joh

48、nson health care compliance programauditing and monitoring self assessments web based tool testing monitoring internal audits “deep dives” third party assessments强生制药公司42johnson & johnson health care compliance programcommunications open door policy hotline investigation protocol case management

49、 system “tone at top” 强生制药公司43 guidant reporting process: your supervisoror managementguidant legalcounselhumanresourceshelpline1-800-xxx-xxxxguidant compliance office or internal audit(all items) (certain items) investigationcorrectiveactionemployee issues reviewed by audit/compliance committees fi

50、nancial/fraud issues audit committee all issues compliance committee 强生制药公司44 helpline call prioritization priority a an “a” priority report involves an emergency or urgent situation. company is called, report delivered immediately. priority b a priority “b” report involves a serious or time-sensiti

51、ve issue that does not rise to the level of an emergency. a completed written report is delivered within a few hours of the calls completion. priority c a “c” priority report involves routine sorts of issues that are not time-sensitive and do not require immediate response by the client. report is d

52、elivered within 24 hours.强生制药公司45guidant helpline call volume by type 012345678910117/989/9811/981/993/995/997/999/9911/991/003/005/007/009/0011/001/013/015/017/019/0111/011/023/025/027/029/0211/021/033/03quantity of calls receivedallegationinterpretationfollow-upinquiry强生制药公司46source11%4%6%48%3%26%

53、1%1%unknowncategories6%10%36%2%13%20%13%policy interpretationhelpline operationunfair treatmentsafety hazardviolation/non-compliancerequest for informationfollow-uphelpline observations sample cumulative statistics 强生制药公司47 all calls investigated all documentation of investigation, conclusions and c

54、losure date maintained by compliance office quarterly review with ethical issues review group (hr/legal/financial audit/compliance senior management)evaluate issueslook for trendsidentify communications needed board compliance committee reviewcurrent follow up process and communication强生制药公司48hhs oi

55、g guidelines enforcement of disciplinary standardsan effective program should include clear and specific disciplinary policies that set out the consequences for violations of company policy or law. companies should adopt processes to ensure consistent enforcement of disciplinary standards.disciplina

56、ry action also may be appropriate where a responsible employees failure to detect a violation is attributable to his or her negligence or reckless conduct. 强生制药公司49hhs oig guidelines responding to detected offensesupon receipt of a reasonable indication of non-compliance, the compliance officer or o

57、ther management official should immediately investigate the allegation.the review should be sufficiently detailed to identify the “root cause” of the problem. as appropriate, the investigation should “include a corrective action plan, a report and repayment to the government, and/or a referral to cr

58、iminal and/or civil law enforcement authorities.”credible evidence of an administrative, civil or criminal law should be promptly reported (i.e., within 60 days) to appropriate federal and state authorities.强生制药公司50johnson & johnson health care compliance programenforcement and disciplinary acti

59、on documented standards of conduct debarment/exclusion checks强生制药公司51johnson & johnson health care compliance programresponse to detected problems and actions to correct issues management action plan hcc committee review process强生制药公司52risk assessment ussc requirement for risk assessment: a requ

60、irement to implement an on-going process to assess the risk of violations and to take steps to address such risks guidant example强生制药公司53risk = potential to interfere with achievement of strategy or business objectivesprocessguidant wide, comprehensive risk assessment identifyprioritizequantifyplancommunicate强生制药公司54risk assessment process cross-functional/bu team of 11 domain exp