Pharma S&M Analytics - Tata Consultancy Services

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Regulatory Bodies and their Principles 1. European Medicines Agency (EMEA) EMEA mission statement is: 2. Medicines and Healthcare Products Regulatory Agency (MHRA) MHRA’s primary objective is: 3. European Federation of Pharmaceutical Industries and Associations (EFPIA) EFPIA is conscious of the importance of providing accurate, fair and objective information about medicinal products so that rational decisions can be made as to their use. 4. Division of Drug Marketing, Advertising and Communications (DDMAC) DDMAC mission is 5. Pharmaceutical Research and Manufactures of America (PhRMA) PhRMA follows the highest ethical standards as well as legal requirements. This code reinforces that interactions with healthcare professionals are to benefit patients and to enhance the practice of medicine. 6. International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) IFPMA and its members provide educational and promotional efforts that benefit patients and promotional programs and collaborations that enhance the practice of medicine. IFPMA also preserves the independence of the decisions taken by healthcare professionals in prescribing medicines to patients. Promotional compliance includes: • Advertisements and mailings • Detail Aids, brochures and others • Internet sites • Exhibition panels, videos and others • Gifts, samples and others • Reprints and others • Hospitality • Representative’s Activities. • Meetings/Symposia • Public Relations • Any other communication Changing Scenario in Sales and Marketing of Pharmaceutical Industry: Role of IT To contribute to the protection and promotion of public health is to safeguard public health by ensuring that all medicines on the UK market meet appropriate standards of safety, quality and efficacy. To protect the public health by assuring prescription drug information is truthful, balanced, and accurately communicated. Promotional activities exclude: • Medical Information o Responses to specific enquiries • Shareholder/business communications o Prescribed Information • Patient Information Leaflets o Price Lists Source – ‘Sales and marketing standards in US and EU: Speaking the same language?’-Paul woods, AstraZeneca 7
Possible Strategies Some possible strategies to comply with current prevailing regulatory environment from an Sales & Marketing perspective are listed in this section. An unbiased approach in terms of communication, education to physicians to improve prescribing habits and in turn patient outcomes are based on: • Appropriate and right communication to right customers. • Evaluating type, ways and means of communication. • Validation of communication. Promotional activities with focus on providing optimal cost effective treatments are based on: • Physician-patient interests • Meaningful and effective communication that can balance the business and customer benefits. • Third-party financial arrangements should incentivize compliance all along the supply chain. Focus on pharmacovigilaince and drug safety activities that have tremendous impact on entire product life cycle (PLC) are based on: • Tracking adverse effects and untoward side effects for the marketed product in a proper form or method. • Post market surveillance studies Changing Customer - Market Dynamics Pharmaceutical industry is witnessing one of the greatest transformations in terms of customer–market dynamics. Not only the key changes like emergence of specialty and super specialty segments, increased regulatory constraints, focus on sub groups in various therapy areas and information explosion in recent times have made the situation complex, but also complicated for the pharmaceutical companies to have a right and meaningful market strategy that can address customers in an appropriate way. Past Scenario in Customer-Market Dynamics • Majority of doctors were general practitioners and physicians • Specialty medicine and super specialty were at the verge of emergence • Needs, wants and expectations were not given importance in company’s expectations • Products had clear cut benefits over predecessors • Scientific data was simple, understandable and easily interpretable • Manageable R&D costs and less burden on Sales & Marketing teams • Congenial and flexible regulatory environment with very less specifications and norms • Less legal and insurance hassles Current and Emerging Scenario in Customer-Market Dynamics • Emergence of sub-groups as important areas of focus • Specialty and super specialty segments • Emergence of physicians as ‘valued partners’ • Patient as a focal point • Direct to consumer marketing • Healthcare network • Personalized medicine • Rising R&D costs • Increased medical and regulatory constraints • More legal and insurance hassles Changing Scenario in Sales and Marketing of Pharmaceutical Industry: Role of IT 8
Page 1 and 2: Changing Scenario in Sales and Mark
Page 5 and 6: The success rate of NMEs, inclusive
Page 7: 2. Focus on emerging markets or BRI
Page 11 and 12: 4. New distribution models based on
Page 17: About Life Sciences and Healthcare

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