Digging Deeper: Focus on Best Practices Medical Affairs Compliance

Transcription

1 Digging Deeper: Focus on Best Practices Medical Affairs Compliance Dr Kelvin Tan MRCP (UK) Vice President Medical Affairs AP Erinn Hutchinson Partner, PricewaterhouseCoopers 1

2 Digging Deeper: Focus on Best Practices Medical Affairs Compliance 2 Joint forum Kelvin Tan Medical Affairs, Allergan AP Erinn Hutchinson, Partner, PricewaterhouseCoopers Focus on Best Practice Share some personal insights Scenario based approach Open forum for discussion

3 Agenda Medical Affairs trends Allergan Medical Affairs structure Discussion scenarios Questions 3

4 Medical Affairs Trends In the last two years, pharmaceutical and medical device companies have expanded their medical science liaison (MSL) operations to include new and larger teams in Europe and Asia In 2012, 67% have MSL teams in Europe, up from 41% in 2010; and 21% have teams in Asia, up from 7% On average, pharmaceutical medical affairs organizations employ 48 MSLs in the U.S, nearly twice as many liaisons as they staff in Europe. Companies have an average 11 MSLs on staff throughout Asia. science liaison teams expanding europe asia/ 4

5 What has happened in U.S. and Europe? Transparency reporting requirements in U.S., Europe, Australia and Japan Complex internal and external procedures Expansion of global and local CPD programs into emerging markets Shift in control of certain activities from commercial to medical affairs 5

6 What s happening in China Now? Drug Administration Law is pending and has been cited as a priority by the Chinese government Building a 21 st Century Pharmaceutical Regulatory System (June 2013), aiming to: Increase transparency and outside participation in the drug evaluation and approval process Promote a scientific administration, i.e., a drug administration system that performs science-based reviews and issues sciencebased decisions Full adoption of international norms for clinical trial applications Promote R&D in China Promote expert independent scientific advice

7 What does this trend mean? China is following the roadmap of U.S. and Europe to separate drug commercialization activities from scientific communication Increasing difficulties to reach KOLs as they may be reluctant to attend activities that may negatively affect their status Medical Affairs Functions and MSLs will become more important in conducting business in the industry: Compliant with the regulations Provide access to highly influential physicians and medical researchers Bring exposure to key healthcare decision-making bodies, such as payers 7

8 What makes me qualified to talk to you about Compliance? 8

9 Why does Medical Affairs have a role in compliance? 9

10 Why does Medical Affairs have a role in compliance? 10 The duties of a doctor registered with the General Medical Council Patients must be able to trust doctors with their lives and health. To justify that trust you must show respect for human life and make sure your practice meets the standards expected of you in four domains. 1.Knowledge, skills and performance 2. Safety and quality 3. Communication, partnership and teamwork Work with colleagues in the ways that best serve patients' interests 4. Maintaining trust Be honest and open and act with integrity. Never abuse your patients' trust in you or the public's trust in the profession

11 Medical Affairs: Who are we and what do we do? 11

12 Who are we and what do we do? 12

13 Scope of Medical Affairs organizations Global Medical Affairs Sole or joint MA ownership of activity 1 Medical information preparing standard responses Medical communications phase IV pubs strategy Advisory Boards Trials phase I IV strategy, phase IV execution IIT strategy and execution Medical communications phase I IV pubs execution Medical information Call centers Medical education strategy, CME execution Medical field KOL strategy, direct exchange with KOLs Biostatistics Epidemiology Pharmaco vigilance Medical education training internal stakeholders Medical communications phase I III pubs strategy, internal and other external medical communications Medical field Direct exchange with non KOL MDs, other HCPs, payors, regulators Trials phase I III execution HEOR strategy and execution Strategy LCM strategy; brand strategy; medical strategy Congress presence Promotional material review Regulatory affairs Drug safety Over 75% of companies 51-75% of companies 25-50% of companies SOURCE: McKinsey Medical Affairs Benchmarking 1

14 What s my process? 14

15 Seek advice 15

16 Global Values CUSTOMER FOCUS IMPACT PEOPLE & PASSION COLLABORATION INNOVATION INTEGRITY Every action we take is with an eye on the Three Ps: the patients who benefit from our products, the physicians who trust our products and the payers who recognize the value of our products. We make an impact going the extra distance to get the very best results, applying the highest standards to all that we do. We value and reward smart, fast action that gets meaningful results. We succeed primarily through our people, whose talent brings quality to our work and whose passion brings commitment not just from processes and structures alone. We are committed to sharing our knowledge and collaborating as a team to reach common goals. We promote and encourage different personal and cultural perspectives that drive new thinking. We are uncomfortable with the status quo. We adapt, we improve, we have the courage to thoughtfully take risks as a team and seize new opportunities for the company and ourselves. We get results the right way, without cutting corners. We are transparent, clear and respectful in our dealings with customers, co workers and partners.

17 The Red Faced Test 17

18 18 Practical Steps 1. Reference internal benchmarks 2. Reference external benchmarks 3. Seek advice 4. Moral compass Do the right thing 5. Focus on the Patient 6. Assess the risk 7. Make a recommendation

19 Discussion Scenarios 19

20 20 Scenario 1 You receive an unsolicited request for an educational grant donation from an independent academic society They have approached multiple different pharmaceutical companies to sponsor their meeting They send you a copy of the agenda which includes references to off-label uses of classes of medication that your company and others promote What are your considerations?

21 21 Scenario 2 You (Compliance & Medical Affairs) are asked to approve a company sponsored educational meeting for HCPs The cross-functional team responsible for the meeting wish to hold the meeting in Country X, where all your company s products are approved The country subsidiaries wish to send delegates from their countries, but you note that not all products are approved in all the countries What are your considerations?

22 Any questions?