18 minute read
Pharmaceutical Promotional Material Gloobal laws overview
Pharmaceutical advertising or prescription/non-prescription drug promotion will remain a widely debated topic, perhaps until a global understanding of regulations surrounding it is established. When it comes to promoting prescription and non-prescription drugs, evolving laws and regulations bring about a complexity like none other in pharmaceutical regulatory Affairs. In multiple countries, the primary source of educating the end users/prescribers is a unidirectional promotional material flow. For a company aiming to launch a molecule in multiple markets insight of the regulations in that market and drawing a comparison to regulated/semi-regulated/unregulated markets may help understand and navigate precedents and complexities. This piece consolidates the current thought process behind promotional material globally and the author’s opinion on pharmaceutical advertising utopia.
One of the most important tasks of any regulatory body is to ensure that pharmaceutical products are developed in accordance with the local/regional regulatory requirements. It not only includes the process of regulating and monitoring the manufacturing of medicines but also the processes of their distribution and promotion.
Advertisement
Therefore, for any global pharmaceutical marketer, it is important to analyse the differences and commonalities of regulatory requirements and pharmaceutical legislation around the world.
Over the last few years, pharmaceutical companies have faced several challenges when it comes to their ad campaigns.
The reasons why the recent news is focused on pharmaceutical advertising and promotions, is- the changing regulations and stricter laws surrounding promotions, put into place by health authorities to keep in check, pharmaceutical manufacturers from often unknowingly making-flawed, misleading, and unlawful statements about their products. Rising fines, notices of violation and cease-anddesist letters cost pharma a lot, and as an industry-wide movement, pharmaceutical companies are now moving towards performing a medico-legal-regulatory review that they should have taken up before beginning to market their products.
With about US$ 1.6 billion spent by pharma in print advertising, approximately US$ 565 million in programmatic ad spend between January 2020 and August 2021, and an expected US$ 15 billion expenditure on influencer marketing by the end of 2022, it’s no doubt that people are talking about pharmaceutical advertising and promotions. The way promotions are done is changing, and it’s time that the laws governing promotion are decoded and communicated to marketeers in a manner that aids compliance.
Where exactly is the problem?
Based on the analysis of an independent survey of over one thousand (1000) recent healthcare advertisements, it was found that: • About 9 per cent of the advertisements contained false or misleading claims • 14 per cent of the ads contained "unsolicited, inappropriate, deceptive, unsupported, or irrelevant advertising" • 44 per cent of the ads included language that would mislead a consumer who did not understand the medical condition and what the product or treatment could do • 12 per cent of the ads misrepresented facts about a specific product or service, and 15 per cent were redundant or inappropriate.
Those are alarming numbers
One may ask why they are even observed with the current set of laws in place. What is the root cause for these misleading advertisements and promotions? The answer to this question is rather simple.
Each country and its regional laws - the existing, the adapted and/or translated, and the deep grey chasms in between, and the inconsistencies in understanding, consolidating differences, and similarities in said laws are the pain points in creating globally compliant promotional material.
Logic demands universally applicable laws, albeit slurred with a slight variation to suit regional nuances often referred to as regional contextualisation.
Therefore, when a comparison was drawn between developed and regulated markets and semi/unregulated ones on promotional material for pharmaceuticals, it was found that almost every country follows the developed nations and regulated markets with slight deviations, However, here the deviations seemed to arise from the ability, or lack thereof, of a statutory body to be able to regulate, legislate and govern while keeping a watchful eye over what’s happening. Or it stemmed from the lack of confidence in developing selfregulation parameters.
Another reason could be that the pharmaceutical manufacturers aren’t looking at specific markets as potential earners and are yet to start heavy promotions there. But we can only speculate.
Let’s take a few examples
Globally, the mandates are rather similar, –barring certain small deviations. • DTC (Direct-to-Consumer) is risky, so do it with care in a mannerism of education • Self-regulate, and we trust you to not mislead the consumers • Do not claim that which is untrue.
Some examples of country-specific deviations are as follows:
• Larger regulated markets like the US and Europe have multiple regulatory authorities, while semi-regulated have a single, or sometimes no specific authority to monitor the promotions • Countries like Ethiopia, Fiji, Zimbabwe, Uganda, Tanzania, Ghana, Venezuela, and Estonia don’t have recent updates and don’t adopt newer methods (especially digital/social) of medical promotions • In countries like Portugal, Estonia, Belarus, Denmark, Ireland, Belgium, and Norway, the definition of advertisement is perceived as being informative rather than communication-focused as compared to others • Finland, Belarus, Czech Republic, Iceland, Portugal, etc. have specifically called out that they do not allow direct comparison with competitor products directed to the general public as compared to other countries Prescription advertisement is prohibited in all countries except New Zealand and the US. Google Ads allows manufacturers to advertise digitally in Canada with certain restrictions • Pharmaceutical manufacturers promote over-the-counter medicines in countries like Australia, Austria, Brazil, Canada, China, Czech Republic, France, Germany, Hungary, Hong Kong, India, Italy, Japan, Kenya, Mexico, Netherlands, New Zealand, Norway, the Philippines, Poland, Portugal, Russia, Slovakia, South Korea, Spain, Sweden, United Kingdom, and the US • The US, UK, North Macedonia, Venezuela, etc., actively monitor promotional material before it is broadcasted to the public and health professionals. However, in a few countries, advertisers do not require pre-approval of their promotional material before being broadcasted.
Advertisers, in terms of copy or creatives, are under immense pressure to follow global mandates and guidelines and are sometimes forced to sacrifice creativity in the pursuit of compliance. This frenzy, clutter in tracking, memorising, and complying with individual country laws have often resulted in global pharma marketers losing track or sometimes completely forgetting submissions, resulting in fines and notices of violations.
Now, what can one do to avoid this confusion? What is the ideal solution for this?
Drug-marketing will have to focus on users, taking a patient first; not a pillfirst approach to communication.
The role of a RAP specialist
At a pharmaceutical company, the regulatory advertising and promotion (RAP) team or the promotional review committee (PRC) is responsible for understanding and interpreting the laws, rules, codes, and guidelines governing prescription drugs' advertising and promotion.
It is imperative that all statements made in advertising, whether express or implied, can be fully substantiated. This is due to the level of accuracy, quality, and honesty required by pharmaceutical and biotechnology companies to support the promotion of medicines and products. This is exactly where the RAP specialist plays a crucial role. The RAP specialist provides advice on strategic adjustment before and after marketing activities when risk-based cross-functional decision-making is critical. When providing strategic advice on drug advertising and promotion, the ability to think broadly and paying attention to detail ensures compliance with the local health authority rules and guidelines.
Those working as RAP (usually medical, legal, and regulatory professionals; a.k.a. MLR committee at times) specialists need a deep understanding of the regulatory framework to ensure business compliance. They should provide strategic regulatory guidance to businesses throughout the pharmaceutical product lifecycle. It is critical that legal, regulatory, and medical teams take the time to understand business goals and support achieving those goals within legal and regulatory constraints. Equally important is that the business groups value the role of external auditors and specialised promotional material consultants in ensuring that products are properly marketed.
In the Advertising Review Committee, friction can often arise between the marketing team and members representing the medical, legal, and regulatory issues. Integrating content with the medical, legal, and regulatory review processes delivers more value to patients and consumers, reduces the cost of producing content, and helps an organisation become a more efficient company. The costs associated with setting up, training, and sustaining a RAP committee can often run into hundreds and thousands of dollars. Hence, smaller companies, and often even large multinationals, are choosing to outsource this function to specialised medico-regulatory consultants and auditors while keeping only legal teams in-house.
On the future of pharmaceutical advertising
The drive to be rational has led people to trust and conjure laws and regulations bound tightly by universal applicability and generalisation.
But context, on how people think, behave and act, is perhaps missing when it comes to pharmaceutical advertising. One of the guiding factors that need to be incorporated in promotional material regulations is the fact that considerations need to be made to susceptibility and the potential influenceability of the intended audience by drawing up certain measures of maturity and self-decision-making capabilities with regards to health by the nation’s populace. When added to self-regulation norms, it makes for better content. A touch of personalisation as a mandate would also generally benefit the sector. For example, if a group values prevention and community medicine, pharmaceutical companies should develop approaches for that group, knowing that traditional pharmaceutical marketing won't work. Instead, they need to understand the social, cultural, economic, and ethical impact of their medicines and use this knowledge to personalise their approach towards consumers. They can no longer focus solely on the positive or negative health effects of drug usage.
Despite limited cost controls, regulatory constraints, and global competition, the drug-marketing space will have to focus on users, taking a patient-first, and not pill-first approach in the future. One thing is for sure, interesting promotions lie ahead.
AUTHOR BIO
Manan Ambani is a Senior Team Lead in Freyr Solutions’ Medicinal Products Division. A pharmacist and MBA graduate from Narsee Monjee Institute of Management Studies (NMIMS) Mumbai, he believes that there is a place for innovation in the everyday lives of all stakeholders, internal as well as external. He holds experience across the pharmaceutical and healthcare value chain, ranging from formulation development and R&D to healthcare advertising and communications.
The world’s rst VOICE ACTIVATED ISOLATOR
Discover the technology that knocks out downtime! Advantages:
Optimization of operating times
Increase in productivity
Less repetitive stress for the operator Reduction of wear of some components
READ MORE
SGS QUALITY-DRIVEN SOLUTIONS
Discovery to commercialisation
We offer high-quality analytical testing solutions for pharmaceutical and biopharmaceutical products through all phases of drug development, from discovery through early development and commercialisation.
Our bespoke testing and clinical service offering, which covers full clinical development from Phase I first-in-human trials to Phase II and Phase III studies in patients, provides reliable and accurate results that ensure the safety of your products and protect patient health. Our experts, working with small and large molecules, use the latest equipment and techniques at our state-of-the-art laboratories and clinical trial facilities in North America, Europe and AsiaPacific. They can assist throughout the development process, providing a range of mission-critical formulation and manufacturing services. We also offer expert guidance from our experienced consulting and project management teams, so you can get your products to market quickly, safely and cost-effectively.
Analytical testing
Using the latest technologies and state-of-the-art equipment, our scientists ensure the quality and safety of pharmaceuticals and biopharmaceuticals during all phases of drug development. We offer a wide portfolio of services, including: • Method development and validation • Analytical chemistry • Microbiology testing • Stability testing
• Bioavailability enhancement • In vitro toxicology • Extractable and leachables testing • Medical device testing
Specific biologics solutions
Our global centers of excellence will cover your testing needs for specific biopharmaceutical products, including vaccines, cell and gene therapies, biosimilars and other biologic products. The solutions that we offer include:
• Structural characterisation and confirmation • Qualitative and quantitative impurity analyses • Physicochemical properties analysis • Biosafety testing
Contract development and manufacturing
We specialize in the development and manufacture of innovative new chemical entities, biologicals and live biotherapeutics for global markets. We offer solutions around:
• Preformulation and CMC support • Formulation development (and the development of supporting analytical methods) • Bioavailability enhancement • Dosage form optimisation, improvements and differentiation • First-in-human supply • Microdosing • Process optimisation • Clinical, specials and commercial manufacturing (including packaging and supply)
Clinical development
We run clinical trials all the way from study design to clinical trial execution, delivery of the final data analysis and producing a clinical study report. Our experts are available to support your studies and to assist with all aspects of formulation development: • Bioanalysis • Drug development consultancy • Early-phase clinical development • Biometrics support • Global clinical trial management
SGS Health Science is much more
Scientific expertise: We provide a diverse range of trusted formulation development, analytical testing, phase-appropriate manufacturing and clinical research solutions that match your needs and help you navigate your journey to market.
Integrated CRO network: Using state-of-theart equipment, our scientists and experts verify the quality, efficacy and safety of therapeutics by providing comprehensive solutions within an integrated CRO network. This encompasses everything from exploratory development and clinical development to commercial QC and postmarket testing. Accelerated drug development: We use innovative techniques that provide patients with better, safer treatments and contribute to your organisation’s success. Global regulatory compliance: Through our global network of laboratories and clinical trial facilities, we offer integrated services and expertise that provide organisations with knowledge, flexibility and the ability to scale while staying compliant at all times. Customer focus: Our specialists deliver multifaceted, customer-centric programs at local and international levels – supporting your commitment to delivering high-quality, compliant biopharmaceutical and pharmaceutical drugs and medical devices.
healthscience@sgs.com sgs.com/healthscience sgs.com/healthcommunity
Dr. Reddy’s partnered with Benchmark ESG | Gensuite to digitalise and enhance their safety culture.
Naveen G.V
Corporate Officer & Managing Director, AAPAC
Ravi JR
Lead Program Manager-SHE Gov. & Audit
Sarang Pande
Head- Digital Transformation and Process Excellence- OSD
1. HOW CAN PHARMACEUTICAL COMPANIES KEEP UP WITH AND EXPAND IN TODAY'S WORLD, WHERE DIGITALISATION AND TECHNOLOGICAL ADVANCEMENTS ARE DRIVING THE INDUSTRY'S EVOLUTION?
In Pharma, as in other industries, we’re in an age where the needs and obligations of companies are evolving by the second – from accelerated product cycles to keeping up with investor and government demands for Environmental, Social, & Governance (ESG) metrics. Digital transformation, in this context is truly an enabler in keeping up, adapting, and moving at the pace of the industry and importantly, adopting a best-practice based digital solution gives companies access to benchmark with global trends, while still being
able to configure the solution to suit specific business’ need. Digitalization can help companies quickly adapt to changing trends, challenges, and opportunities with confidence.
I agree! The evolving regulatory landscape, old and new diseases, and the need for efficient manufacturing operations mean that pharma companies need to step up and fast. Boosting their digital infrastructure is the only way to succeed in a world where disruptive technologies are changing the pharma landscape at a pace that is faster than businesses’ adaptive capacities. Companies that hope to thrive should look at the digital opportunities in their entire ecosystem – from enhancing their product’s journey through production and delivery to empowering employees and unlocking new revenue streams. workflows is just one aspect of digital transformation. There’s also the immensely powerful EHS data that possesses the ability to inform of critical safety decisions, allocating resources in the right direction, preventing accidents, and saving lives! By deploying a single digital EHS management platform that can manage companywide safety data, EHS teams can drive measurable improvements and use analytics to uncover hidden risks to the safety of employees.
Naveen G V is an Environmental, Health & Safety (EHS) and Management professional with 23+ years of experience spanning across Government, Consulting and Industry sectors. He is currently the Managing Director, AAPAC & Corporate Officer for Benchmark Digital Partners LLC, US & Benchmark ESG Pvt. Ltd., India, a US headquartered Company offering software solutions to global customers in managing their Environmental, Social & Governance (ESG) program. In his earlier role, Naveen was the EHS Leader at General Electric (GE) at Bangalore. Naveen has a Master’s degree in Environmental Engineering and is also a Lead Auditor for ISO 14001: Environmental Management System and RC 14001: Responsible Care Management System covering environmental, health, safety, security, product stewardship and outreach activities.
2. EFFICIENT MANAGEMENT OF ENVIRONMENTAL, HEALTH, AND SAFETY (EHS) IS CRITICAL FOR EVERY ORGANISATION. HOW CAN DIGITALISATION ENHANCE EHS MANAGEMENT IN PHARMACEUTICAL INDUSTRIES?
EHS digital transformation is the key to keeping your safety culture proactive! It can help pharmaceutical companies improve employee wellness and workplace hygiene, streamline compliance and reporting, increase sustainability, and improve programme performance. Now automating and streamlining
3. WHAT WERE THE DRIVERS FOR DR. REDDY’S TO DIGITISE THEIR EHS AND ESG PROGRAMMES?
At Dr. Reddy’s, we prioritise workplace safety by using the My Safety Index (MSI), a quantitative tool to monitor safety culture and management across our sites, measuring parameters like the LOTO index and Contractor Safety Management (CSM) index. As testament to our commitment to sustainability, we’re the first Indian pharmaceutical Company to commit to the Science Based Targets (SBTi) and our EHS Policy has been revised to take a holistic approach towards sustainability throughout our value chain. You can see that safety and sustainability are top priorities! When we looked at the scope of our safety and sustainability programmes, we identified the need for a digital system that could streamline workflows and increase efficiency across our EHS and ESG programmes.
4. HOW DID DR. REDDY’S GO ABOUT THE PROCESS OF IMPLEMENTING DIGITAL TECHNOLOGIES FOR THEIR EHS AND ESG PROGRAMMES?
It was important that our EHS digital partner was aligned with our core values of sustainability and our commitment to workplace safety. We zeroed in on Benchmark ESG | Gensuite, drawn to their best-practice-based EHS and ESG digital platform and a strong legacy of supporting organisations across the world in creating safer workplaces. We expressed our needs for an intuitive and user-friendly platform that can streamline workflows and help our safety leaders make critical decisions. When we implemented Gensuite digital system for our EHS and ESG needs, we adopted a phased approach. Implementing across two phases, we created smaller milestones, aiming at efficiently driving critical safety actions to closure,
engaging employees in enhancing workplace safety, and meeting compliance needs. To date, we’re continuously innovating to improve our safety and sustainability culture, exploring newer opportunities and other advanced technologies.
5. WHAT VALUE AND RETURNON-INVESTMENT (ROI) HAS DR. REDDY’S SEEN BECAUSE OF THEIR EHS DIGITAL TRANSFORMATION? (DR. REDDY’S)
Our employees are at the heart of our EHS programme! Digitalising our EHS processes has created a lasting impact on our safety culture, engaging employees, and empowering leadership to take critical decisions through impactful safety and sustainability data stories. Sure, we’re saving time, cutting down on costs, and experiencing enhanced employee productivity, but we’re exceptionally proud of the strong safety culture we’ve been able to build due to our digitalisation efforts. We can’t wait to dive deeper into the digital world, reaping all the benefits that advanced technologies like artificial intelligence (AI) have to offer in keeping our teams safe and the environment thriving.
6. WHAT APPROACH WOULD YOU RECOMMEND TO YOUR PHARMACEUTICAL INDUSTRY PEERS WHO ARE LOOKING TO START THEIR EHS DIGITAL JOURNEY?
Under the larger umbrella of the pharma industry, each company is unique with diverse culture and values. However, building a digital EHS & ESG management system from scratch can be timeconsuming and it may take years before you develop meaningful workflows. Look for a best-practice-based digital provider like Gensuite who can quickly automate your EHS workflows and customise their platform to meet your unique needs. As a next step, secure leadership buy-in by showing your leaders the power of data and technology in securing the safety of your teams. When implementing these technologies, start with smaller pilot projects. Use these as a guide to initiate enterprise-wide implementation, moving towards imbibing digital EHS into your organisation’s safety and sustainability culture. We believe that choosing the right digital partner is key – someone who listens to your unique needs, has the domain expertise and works carefully to meet these long after the initial implementation!
7. HOW DO YOU SEE THE FUTURE OF DIGITALISATION IN EHS IN THE PHARMACEUTICAL INDUSTRY?
Advanced technologies, especially AI, are taking the pharma industry by storm! From drug development to epidemic prediction, AI is fostering innovation, improving productivity, delivering better results across the value chain, and creating new business models. And EHS is no exception! It’s critical to processes across every function of pharma companies. With advanced technologies like AI, machine learning (ML), and predictive analytics, EHS professionals in pharma companies can identify and prevent fatal injuries and improve safety performance with increasing accuracy. Take Benchmark ESG’s PSI AI Advisor™ for instance. It identifies risk factors for potentially serious injuries (PSIs) in real time, helping safety leaders prevent the occurrence of workplace incidents that have the greatest potential for harm, saving lives in the process.
8. IS THERE ANYTHING MORE YOU'D LIKE TO SAY TO OUR GLOBAL AUDIENCE?
The ESG spotlight is on companies worldwide and pharma companies are no exception! With mounting pressure from investors, government, regulators, and consumers, to report investmentgrade ESG data, pharma companies need to address the challenge – initiate climate action, reduce their Global Greenhouse Gas (GHG) emissions, report progress, and simultaneously keep their businesses sustainable and thriving in the long-term. Benchmark ESG’s intuitive and userfriendly digital solutions help you achieve your sustainability goals by seamlessly collecting and reporting investment-grade ESG data across global frameworks like GRI, CDP, SASB, BRSR, etc. Additionally, our solutions help you harness the power of detailed data and precise analytics to inform ESG strategies & maximise your performance.
It’s exciting to see how advanced technologies and digital transformation can enhance safety and sustainability processes in pharmaceutical companies. We encourage organisations to be open to this transition and dive into this exciting landscape with hope and optimism.
