Regulatory Affairs Tutorial #2: Regulatory Ethics


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Regulatory Affairs Tutorial #2: Regulatory Ethics

  1. 1. Regulatory Affairs Tutorial #2 ETHICS AND REGULATORY INTELLIGENCE Philipp Novales-Li, DMedSc, PhD, DPhil (Oxford), RAC
  2. 2. SCOPE <ul><li>Topics to be Covered </li></ul><ul><li>● Basics of Regulatory Intelligence </li></ul><ul><li>● Relevance of Ethics to Regulatory Intelligence </li></ul><ul><li>● Ethics: Relevance and Conflict Problems </li></ul><ul><li>● Analyzing and Resolving Ethical Problems </li></ul><ul><li>● Case Studies </li></ul><ul><li>● Conclusion </li></ul>
  3. 3. REGULATORY INTELLIGENCE: Definition <ul><li>What is Regulatory Intelligence? </li></ul><ul><li>● A systematic approach for gathering and analyzing information about your competitor’s regulatory activities </li></ul><ul><li>● A tool for knowing the difference between information and intelligence. </li></ul><ul><li>◊ Information is factual. </li></ul><ul><li>◊ Intelligence is a collection of information which have been filtered, distilled, and analyzed. </li></ul><ul><li>● Regulatory intelligence is the core of regulatory strategy. </li></ul><ul><li>● Regulatory intelligence helps regulatory executive make decisions. </li></ul><ul><li>● Intelligence is knowledge. </li></ul>
  4. 4. REGULATORY INTELLIGENCE: Benefits <ul><li>What are the Benefits of Regulatory Intelligence? </li></ul><ul><li>● Anticipate changes in the regulatory space </li></ul><ul><li>● Anticipate actions of competitors </li></ul><ul><li>● Learn from the successes and failures of others </li></ul><ul><li>● Learn about new technologies, products, and regulatory processes </li></ul><ul><li>● Look at one’s own regulatory strategies with an open mind </li></ul><ul><li>● Help implement the latest regulatory tools and concepts </li></ul>
  5. 5. REGULATORY INTELLIGENCE: Process <ul><li>What are the Steps of Regulatory Intelligence? </li></ul><ul><li>● Planning and direction </li></ul><ul><li>● Collection and research </li></ul><ul><li>● Processing and storage </li></ul><ul><li>● Analysis and production </li></ul><ul><li>● Dissemination and delivery </li></ul>
  6. 6. ETHICS: Relevance to Regulatory Intelligence <ul><li>Why is Ethics Relevant? </li></ul><ul><li>● Truthfulness must dictate collection and reporting of facts </li></ul><ul><li>● The downside of stepping over the line is far too severe </li></ul><ul><li>● Supports judgment and conduct to distinguish right and wrong </li></ul><ul><li>● Provides guidance to decision-making processes and courses of action </li></ul><ul><li>● Ethical behavior reflects a profession’s integrity </li></ul>
  7. 7. ETHICS: Definition <ul><li>What is Ethics? </li></ul><ul><li>● The conscious reflection of our moral beliefs and attitudes (L. Hinman) </li></ul><ul><li>● The treating of moral questions (Oxford Dictionary) </li></ul><ul><li>◊ Morals: Rules and guidelines of what is right or wrong, good or evil </li></ul><ul><li>● A code of behavior considered correct (Chambers Dictionary) </li></ul>
  8. 8. ETHICS: Relevance and Conflict Problems <ul><li>What are the Most Common Ethical Problems? </li></ul><ul><li>● Conflict Problems </li></ul><ul><li>◊ Faced with two or more moral principles which seem to apply to a particular situation, and yet, the two principles require different and incompatible actions </li></ul><ul><li>● Relevance Problems </li></ul><ul><li> ◊ Uncertainty whether a moral principle applies in a particular situation. </li></ul>
  9. 9. ETHICS: Analyzing Ethical Problems <ul><li>How do we Analyze Ethical Problems? </li></ul><ul><li>● Factual Issue </li></ul><ul><li>◊ An issue having to do with the truth or falsehood of factual claims </li></ul><ul><li>● Conceptual Issue </li></ul><ul><li>◊ An issue having to do with the meaning or scope of a term or concept </li></ul><ul><li>● Moral Issue </li></ul><ul><li>◊ The relevance or application of one or more moral principles </li></ul>
  10. 10. ETHICS: Resolving Conflict Problems <ul><li>How Should We Resolve Conflict Problems? </li></ul><ul><li>● Finding the creative middle way </li></ul><ul><li>◊ It is possible to satisfy ethical requirements in a modified form </li></ul><ul><li>◊ A way to minimize the conflict between two norms </li></ul><ul><li>◊ Not necessarily an ethical compromise, since two norms have great importance </li></ul><ul><li>● Employing lower-level considerations </li></ul><ul><li>◊ All things being equal, it may be justifiable to consider other options that are more relevant </li></ul><ul><li>● Making the hard choice </li></ul><ul><li>◊ Sometimes, no creative middle way is possible </li></ul>
  11. 11. ETHICS: Resolving Relevance Problems <ul><li>How Should We Resolve Relevance Problems? </li></ul><ul><li>● Set up a series of cases </li></ul><ul><li>◊ Ranging from a case where the concept clearly applies </li></ul><ul><li>◊ Through a series of ambiguous cases </li></ul><ul><li>◊ Up to a case in which the concept clearly does not apply </li></ul><ul><li>● Enumerate similarities and differences among the various cases </li></ul><ul><li>◊ Determine what is and is not morally relevant </li></ul><ul><li>● Determine the line of demarcation </li></ul><ul><li>◊ A certain amount of arbitrariness may be involved in setting precise boundaries </li></ul>
  12. 12. CASE 1: Misrepresentation --- Scenario <ul><li>Passing Yourself Off as Someone Else </li></ul><ul><li>● A regulatory professional may pose as a researcher or a potential customer, contacting a competitor by phone to obtain information on a competitor’s products and services. Or, at various tradeshows, a regulatory professional represents oneself as being affiliated with a society or university, rather than with one’s current employer. </li></ul>
  13. 13. CASE 1: Misrepresentation --- Problem/Analysis <ul><li>Nature of Problem / Analysis </li></ul><ul><li>● Nature of Problem </li></ul><ul><li>◊ Conflict Problem: Truthfulness / Honesty </li></ul><ul><li>◊ Relevance Problem: Truthfulness </li></ul><ul><li>● Analysis </li></ul><ul><li> ◊ Facts: One can be both a competitor’s competitor and a competitor’s customer; One may be affiliated with a professional society </li></ul><ul><li> ◊ Concepts: Should claimed affiliation be strictly with one’s employer? </li></ul><ul><li> ◊ Morals: All representations are correct. Is concealing affiliation with one’s employer being untruthful or dishonest? </li></ul>
  14. 14. CASE 1: Misrepresentation --- Resolution <ul><li>Ethical Courses of Actions </li></ul><ul><li>● Do’s </li></ul><ul><li>◊ Be forthright </li></ul><ul><li>◊ Display your badge clearly at tradeshows </li></ul><ul><li>◊ Identify where you are calling from </li></ul><ul><li>◊ Clearly state your objective </li></ul><ul><li>● Don’ts </li></ul><ul><li>◊ Use another person’s badge at a tradeshow </li></ul><ul><li>◊ Claim affiliation with an indirect third party </li></ul><ul><li>◊ Pass yourself off as someone else </li></ul>
  15. 15. CASE 2: Interview Expedition --- Scenario <ul><li>Culling Information During Job Interviews </li></ul><ul><li>● A regulatory affairs manager has a position open for an associate. Various candidates applied, including one from a major competitor. Although other competent candidates have been interviewed, the RA manager decides to invite this candidate from the competitor. During the interview, the RA manager queries the candidate about the competitor’s RA organization, strategy, and product launches. (NOTE: The same scenario holds true with a regulatory professional who uses job interviews with competitors as a means to carry out intelligence activities.) </li></ul>
  16. 16. CASE 2: Interview Expedition --- Problem/Analysis <ul><li>Nature of Problem / Analysis </li></ul><ul><li>● Nature of Problem </li></ul><ul><li>◊ Conflict Problem: Truthfulness / Honesty / Confidentiality </li></ul><ul><li>◊ Relevance Problem: Confidentiality </li></ul><ul><li>● Analysis </li></ul><ul><li> ◊ Facts: Is the interview being carried out in earnest, i.e. for purposes of hiring and not for intelligence gathering? </li></ul><ul><li> ◊ Concepts: What constitutes confidentiality? Is it specific to a company’s procedural definition of the term? </li></ul><ul><li> ◊ Morals: Is there a conflict between good and bad if information is being provided freely during the interview process? </li></ul>
  17. 17. CASE 2: Interview Expedition --- Resolution <ul><li>Ethical Courses of Action </li></ul><ul><li>● Do’s </li></ul><ul><li>◊ Desist from seeking intelligence-type information </li></ul><ul><li>◊ Be honest about the intention of the interview </li></ul><ul><li>◊ Limit the interview questions to HR’s script </li></ul><ul><li>◊ Ask an applicant discreet questions </li></ul><ul><li>● Don’ts </li></ul><ul><li>◊ Promise an applicant a job under false pretences </li></ul><ul><li>◊ Ask a job applicant indiscreet questions </li></ul><ul><li>◊ Use the job interview process to conduct intelligence activities </li></ul>
  18. 18. OTHER AREAS OF ETHICAL CONSIDERATION <ul><li>Other Unethical Regulatory Intelligence Practices </li></ul><ul><li>● Eavesdropping </li></ul><ul><li>◊ Listening to a third party’s private conversation in a public place </li></ul><ul><li>● Conflicts of Interest </li></ul><ul><li>◊ Representing clients who are each others competitors, but providing similar intelligence materials </li></ul><ul><li>● Rubbish Archeology </li></ul><ul><li>◊ Rummaging through a competitor’s garbage (i.e. dumpster diving) </li></ul>
  19. 19. CONCLUSION <ul><li>Quo Vadis? </li></ul><ul><li>● Regulatory professionals must balance collecting regulatory intelligence to address corporate needs while simultaneously ensuring that ethical boundaries are not overstepped. </li></ul><ul><li>● Regulatory professionals need to inculcate ethics in the practice of regulatory intelligence gathering and rely on intuition to differentiate ethical from unethical practices in ambiguous situations. </li></ul><ul><li>● Companies must develop strong ethical cultures in competitive information gathering. </li></ul><ul><li>● Always refer to your Code of Ethics as your guidepost. </li></ul><ul><li>● Ethical behavior is a salient factor for a professions’ survival. </li></ul>