Uniform Code of Pharmaceuticals Marketing Practices

Transcription

1 Uniform Code of Pharmaceuticals Marketing Practices January 2015

2 Contents Marketing Message board Background practices in media 4 Unlocking the 5 Questions to ask UCPMP yourself 7 Our approach and 8 Partnering with methodology PwC 6 UCPMP Framework Assess yourself Slide 2

3 Message board Sanjay Dhawan Partner Pharma GRC Lead for PwC India Dear All, The Uniform Code of Pharmaceuticals Marketing Practices (UCPMP), issued by the Department of Pharmaceuticals, came into effect in India from January 1, The UCPMP is to be voluntarily adopted and implemented by pharma companies within a period of six months. We believe that the code will inspire great confidence among patients and demonstrate India s commitment to a high level of ethics & compliance. A statutory code would work as a ready reference and guide in pharma marketing. In this document, we have highlighted the key elements of the code and the approach required by pharmaceutical companies to successfully implement the same. Regards, Sanjay Slide 3

4 Background Pharmaceutical companies work in an highly regulated environment across the globe. Every act done by this Industry is closely monitored by regulatory bodies. In India the code around marketing practices for pharmaceutical products was not made mandatory. The draft was issued in 2012 by department of Pharmaceuticals. Certain incidents in the media during past few years, have built a pubic perception that pharma companies have an influence on health-care professionals. The Department of pharmaceuticals has now issued a the Uniform Code of Pharmaceuticals Marketing Practices (UCPMP) effective January 1, This is voluntary for a period of 6 months and government may consider making it a statutory code. Slide 4

5 Marketing Practices highlighted by media Slide 5

6 What does UCPMP mean to you Unlocking the UCPMP Code Response Required Stakeholders Product related claims and comparisons Textual and Audio- Video Promotional material Samples Medical representative Compliance to all the components, complaints handling mechanism and self assessment for CEO Certification Policies and procedures for do s and do not s. Regular training programs, Coordination between execution and monitoring team Transactions done by: Business Unit Marketing Medical Sales Force Internal Stakeholders Monitored and guidance provided by: Executive committee Legal Compliance Internal Audit Gifts Relationship with HCP s External Stakeholders Mode of operations and complaint handling Adequate Contracts with Third parties. Co-ordination with monitoring bodies Transactions done by: CFA s / Distributor Monitored and guidance provided by: Government Managing Director / CEO Certification Liasioning Agents Ad. agencies Associations Patient bodies Slide 6

7 Questions to ask yourself The company should have a process with adequate controls for compliance to the code. Listed below are some illustrative activities done by pharma companies and illustrative questions related to process/ controls which determine compliance to the code: Third party Sponsorship Is this an approved institute Samples Do we have adequate records of samples given (including HCP request) CME s Is honorarium commensurate (fair market value) to the services Promotional material Do they contain all required information Is this being given for a scientific purpose Are controls in place to ensure threshold (eg. Three patient dosage) Is there a standard mechanism to calculate honorarium documented Is there a process to avoid words such as new or safe and HCP photos Has this request come from an authorized person in the institute Do we have a process for distribution of cold chain / High value products Are there controls in place to ensure incentives are not provided to any delegate such as accommodation, travel or leisure trip Is there a database to track all promotional material with requisite approvals Slide 7

8 UCPMP Framework Assess yourself Described below are Illustrative components of the framework required to implement compliance to the code. CEO Cert. Self Assessment tool Internal controls Defined Process Corporate Policies Certification by CEO Confirmation of code understanding by employees Employee wise certification process Third party confirmations Marketing process review plan Escalation matrix and Process for non-routine transactions Disciplinary actions for non-compliance Documented process with relevant templates Regular trainings Continuous monitoring and documentation Marketing Integrity Anti Bribery Gifts Product donation / free goods Record Retention What are your plans to implement this code: Will you be adopting the voluntary code immediately Will you be providing CEO certification on your website by February 11, 2015 Have you detailed out the changes required in your marketing practices to comply with the code Do you want to wait and watch for six months, to see if the code gets translated to a statute Slide 8

9 Our approach and methodology PWC s UCPMP evaluation and implementation is based on the following four step approach 4 1 Identify Understand policy context and activities done by the company Engage with key stakeholders ~ policy and process owners, interest groups and end users Identify and agree business requirements, key risk & impact areas Test and Refine Conduct workshop of various stakeholders highlighting key policy guidelines and process changes Discussion with management and policy owners Obtain feedback and realign policies and procedures PwC Approach Diagnose Evaluate the current organization structure, functional and operating model Identify relevant local (Indian) legal & compliance requirements, industry standards; practices etc. Benchmark with global industry and Client s own code and global policies Assess code impact areas and make recommendations (options) Design and Draft Agree policy structure and design framework and process for implementation Document policy & procedural guidelines and illustrations, as required Perform quality review and reference with legal & other design parameters 3 2 Slide 9

10 Partnering with PwC Benefits you reap Having adequate policies in place for compliance to the code Documented processes and instructions (with relevant templates and forms) throughout the company to implement the policies Assistance in the roll-out of the code with adequate training programs Adequate monitoring mechanism to bring out the deviations and outliers Framework for the Managing Director / CEO certification Slide 10

11 Thank You!! Contact Us! Deepankar Sanwalka Tel: Arup Sen Tel: Manpreet Singh Ahuja Tel: Neeraj Gupta Tel: Sivarama Krishnan Tel: Siddharth Vishwanath Tel: Harpreet Singh Tel: Sanjay Dhawan Tel: Tapan Ray Tel: Parin Shah Tel: For more information log on to This publication has been prepared for general guidance on matters of interest only, and does not constitute professional advice. You should not act upon the information contained in this publication without obtaining specific professional advice. No representation or warranty (express or implied) is given as to the accuracy or completeness of the information contained in this publication, and, to the extent permitted by law, [insert legal name of the PwC firm], its members, employees and agents do not accept or assume any liability, responsibility or duty of care for any consequences of you or anyone else acting, or refraining to act, in reliance on the information contained in this publication or for any decision based on it All rights reserved. PwC, a registered trademark, refers to PricewaterhouseCoopers Private Limited (a limited company in India) or, as the context requires, other member firms of PwC International Limited, each of which is a separate and independent legal entity. DJ-2056-DDC