John Chinnici examines the different external regulatory systems of various countries, the challenges they present to pharmaceutical marketing teams and the processes/ technologies used to overcome them.
In the past few years, emerging or ‘pharmerging’ markets have been heralded as the hottest growth area for the biopharmaceutical industry.1With large populations, growing disposable income and unmet chronic medical needs, markets such as China, Turkey, Russia, Poland, India, Brazil and others have seen double-digit growth rates in pharmaceutical spending. In fact, 17 ‘pharmerging’ markets will account for 28% of total spending by 2015, up from only 12% in 2005.2 It’s no surprise, then, that multinational biopharmaceutical companies want to tap these markets as the growth potential could more than offset stagnating sales in mature markets. It’s a pharmaceutical field of dreams.
Even outside of ‘pharmerging’markets, existing markets are changing dramatically. As the world gets smaller, pharmaceutical brand awareness is crossing national boundaries.Also, with increasing cost pressures across the industry, multinational companies are realizing the importance of spreading their wings far and wide to realize the cost benefits of marketing on a larger scale. This, plus the additional social marketing channels causing governing bodies to scramble to establish new regulations, compounds the complexity of managing promotional materials globally.
Success, therefore, depends on moving quickly and adapting new global strategies that simultaneously marry local insights and experience. No defined strategic blueprint exists that can be applied uniformly across these extremely heterogeneous countries – especially when it comes to marketing. Yet, today’s pharmaceutical marketing teams must develop harmonious messaging across borders in order to meet corporate cost containment goals and maintain a consistent brand globally while complying with regulatory rules specific to every country.
The Regulatory Labyrinth
All across the globe, health authorities are fundamentally changing the way in which life sciences organizations conduct business. In Europe, for example, the Association of the British Pharmaceutical Industry recently voted in amendments to its Code of Practice to increase the transparency of working practices between the industry and healthcare professionals. Pharmerging markets especially have unique, sometimes unpredictable, regulatory rules resulting from governmental efforts to curb health care costs or to spur growth of the domestic biopharmaceutical industry. Russia, for example, aims to ensure that by 2020 at least 50% of pharmaceuticals (by value) sold on the Russian market are produced by local manufacturers.
The bottom line is that different organizations operating in different countries have different regulatory requirements, impacting not only the marketing content being created but also the context and target audience. Many organizations in the United Kingdom, for example, adhere to a self-certification process. To contrast, some organizations in France, which has one of the most rigid regulatory systems in the world, require that all promotional materials be filed and approved before being disseminated. Many Italian organizations have a 10-day waiting period after before executing promotion ‘at risk.’ And within the German market, the #1 drug market in Europe, companies require long audit trails and comment histories to be available indefinitely. These are just a few varying regulatory requirements. In addition to the country-by-country and company-by-company variety, many of these requirements change almost as often as the weather. For marketers, keeping up is like trying to nail an egg to a tree – practically impossible.
“The number one issue that content management vendors need to address surrounds global compliance. Today, compliance challenges – and more broadly regulations and policies – extend well beyond the domestic borders,” said Pierre Morgon, VP of Franchise & Global Marketing Strategy for Sanofi Pasteur. “As an example, take a look at the ICH, aimed at aligning various international regulatory guidelines. Brazil, too, has reformed the way it evaluates the regulatory submissions. So while some countries strive to be self-sufficient, there is still a convergence of regulatory requirements across the globe while some maverick countries – especially China – seem to be willing to take an altogether different approach and create their own standards. This creates problems when managing regulatory content in any consistent way around the globe, so we need our systems to be able to adapt rapidly to this ever shifting global compliance landscape.”
But here’s the biggest problem: keeping track of content. Where is the latest version? What changes have been made, and are they reflected in all of the proceeding versions or uses? Does the current version reflect the local regulatory requirements? What stage of the development and approval process is a piece in Germany versus Italy or the UK? Naturally, with so many different regulations and participants involved in developing a single globally useful promotional material, there’s a high degree of variability that is difficult to manage manually or even through disparate systems at the local level.
“Traditional content management systems have always fallen short when it comes to enabling content consistency across international borders,” added Morgon. “Claims that support a given product and that are documented in the original repository must be made available to other countries and affiliates. The countries can tweak the storyline a little to mirror the local culture, the competitive situation, or the local regulatory requirements, but the product datathat back the claimsshould...indeed must...remain the same.”
Typically, headquarters will release approved content that must be tailored to each market. However, once corporate sends out the material usually via email or FTP, they lose visibility into where or how that promotional piece has been used. This ‘throw it over the wall’ approach is inherently risky from a regulatory perspective,resulting in a proliferation of uncontrolled content copies and a sense of version confusion as people are unsure which document version is the most current. Instead, companies are shifting from processes and technologies that are restricted to local requirements to truly global operations that also account for local regulations. This shift requires never-before-seen levels of system and process flexibility to address local, shifting regulatory requirements worldwide.
But therein lies the issue. With traditional technology, a system designed to offer this level of flexibility is simply out-of-reach for most global affiliates that have limited budgets. Plus, these affiliates rarely have the IT resources on staff to manage such complex technology. Today’s life sciences companies need a no-hassle, easy to manage and affordable system that enables efficient promotional materials management.
Adding Social Media to the Mix
Pharmaceutical companies have just recently started to increase their investment in social marketing strategies despite the potential risks that lurk just below the surface. In spite of the lack of a comprehensive regulatory framework for direct-to-consumer social media marketing, adverse event monitoring and reporting, and a fuzzy return on investment, a recent report found that digital marketing (primarily using social media channels) as a percentage of marketing mix amongst pharmaceutical companies rose to its highest level in 2011. Digital channels are defined in the report as owned websites, sponsored websites, ad spots, banner ads, paid search, mobile and social media including blogs, forums, LinkedIn, Facebook, Twitter, Flickr and video share portals like YouTube.
It’s all exciting stuff for pharmaceutical marketers everywhere, but it also raises the question of how social marketing and other forms of new media are controlled by regulatory agencies.
“In addition to thinking about regulatory requirements from a geographic perspective, we really need to consider how the geographically neutral internet affects things. Social media is changing the way in which patients and other stakeholders consume information,” said Ian Talmage, senior vice president of Global Marketing at Bayer Schering Pharmaceuticals. “The pharmaceutical industry in general – and regulators specifically – must develop a better awareness and understanding of these kinds of social media channels with regard to the regulations that govern them. If we want to leverage the benefits of such new media, then content management technology needs to enable parallel conversation, controlled management of data and real-time response.”
In the U.S., the FDA has tried to put some guidelines together surrounding social media, but the rules are unclear insomuch as they do not and cannot identify every possible violation; they are still evolving. In fact, any application of the existing regulations is enforced on a case-by-case basis, lacking any consistency. It has left life sciences companies asking the FDA for an official social media policy to quell any risks. In April 2011, the U.K.’s Prescription Medicines Code of Practice Authority (PMCPA) published some social media usage guidelines based on interpretation of the Association of the British Pharmaceutical Industry (ABPI) Code of Practice. But, most of the pharmaceutical regulatory bodies across the globe have yet to publish clear guidelines for social media use. Instead, regulatory agencies are often playing catch-up when it comes to compliance around new media by issuing new rules ‘post haste,’ forcing pharmacos to likewise double-back on social media campaigns or messages to account for these regulations – country by country.
With that level of rapid regulatory change, companies need the flexibility to be able to rethink their strategies and executions based on these changes. And they need a system that’s as flexible and responsive in order to keep up.
Wanted: New Process for Global Control/Local Flexibility
So, what’s the answer? How do pharmaceutical marketers maintain messaging and promotional material consistency across borders while also following the distinct rules for each and every government?
The answer is in the clouds – literally. Modern cloud technology supports multitenant Software as a Service (SaaS) applications, which are innately designed to provide maximum levels of flexibility. The optimal multitenant cloud-based content management systems are highly configurable – as opposed to customizable – and enable fast, easy upgrades so companies can realize the benefits of new features (some of which are included to accommodate regulatory requirements) that are automatically delivered through the Cloud. They also make it easy to simply turn settings off/on, preset workflows and make changes to accommodate the regulatory requirements of each market. With traditional client/server content management systems, life sciences companies must custom-build their system for each individual market. These customized systems require long implementations (6 months or more), extensive end-user training due to the specificity of the system, and costly and time-consuming upgrades whenever a change is needed.
Optimal cloud-based systems, in contrast, can be configured in just minutes to accommodate a regulation change, for example– and without disrupting the overall system. The cloud enables companies to have a single instance of an application that can be accessible by anyone anywhere in the world, plus integrated individual instances for different countries or areas of the company. Each instance of the application has its own administrative authority for both local flexibility and overall enterprise-wide control. This ‘local flexibility/global control’ combination dramatically streamlines promotional materials management across the enterprise. Customers benefit from just one global audit trail, one software version, one security strategy, one product master and one employee master.
Additional advantages of cloud-based content management systems include:
Cloud technology – with its inherent flexibility and accessibility – offers the power to dramatically improve how global life sciences companies navigate the varying, country-to-country regulatory labyrinth. It’s no longer a question of “if;” it’s a question of “when” – when pharmacos will make the switch. Stay tuned to see how the cloud offers the same level of support when it comes to managing internal governance or promotional materials. (And while you wait, ask yourself: do you know precisely where your ad is in the review cycle right now?).
1Defined as countries with >$1billion absolute spending growth over 2011-2015 and GDP per capita of less than $25,000 on a purchase-price parity basis (PPP). Includes China, Brazil, India, Russia, Mexico, Turkey, Poland, Venezuela ,Argentina, Indonesia, South Africa, Thailand, Romania, Egypt, Ukraine, Pakistan and Vietnam. IMS Institute for Healthcare Informatics (2011).
2 Source: IMS Market Prognosis, April 2011
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