4 Steps to Achieve Compliant Packaging for Mandatory Regulations
Over the next two years, prescription and over-the-counter medicine labels in Australia and New Zealand will change. Due to consumers’ demand for more informed choices about their medicines, the Therapeutic Goods Administration is requiring new pharmaceutical labelling regulations to align with international best practice.
Medicine labels are required to comply with the new rules by 1 September 2020.
What packaging and labelling details are changing?
Active ingredients will need to be more prominent on medicine labels with larger print sizes on the front label. The active ingredients will be positioned on the package under the brand name on the front label. This will ensure consumers are not mixing medicines that could alter the effectiveness, and to assist consumers in making informed choices. Consumers can expect to see these changes on sunscreen and vitamin supplements too.
Along with larger font sizes, the new medicine packaging will also include critical health information to increase clarity on what a particular product is to be used for.
For prescription drugs, the new rules indicate there will need to be extra space for pharmacists to attach their dispensing labels without covering up other information.
Australian and New Zealand medicine labels will soon be required to include details about:
Storage conditions. To reduce the risk of storing medicine incorrectly, labels will be required to include directions on how to store a product.
Expiration date. Consumers are familiar with the “use-by date” on food products — now medicine labels in Australia will be required to include the expiry date to protect consumer from expired or unsafe medicines.
Batch number and company address. The batch number, name, and address of the supplier will be included — to be used to trace medicine and easily manage recall efforts. Medicines sold in Australia will display either an AUST R number or an AUST L number.
AUST R (registered) medicines include all prescription-only medicines and many over-the-counter medicines.
AUST L (listed) medicines are lower risk, self-medication products, such as fish oils, multivitamins, and herbal and homeopathic products.
Allergens. Under the new labeling rules, more allergens (fish, eggs, soy, milk, and tree nuts) will need to be disclosed on non-prescription medicine labels. For prescription drugs, this callout must appear on the label or in the Consumer Medicine Information leaflet with a prompt on the pack.
What does this mean for brands?
To turn these pharmaceutical labelling requirements into a competitive advantage, follow these four steps:
1. Engage with a business partner that can enable development of packaging that is compliant and ensures brand guardianship — with compliance and speed to market as the basis of the process which is GMP compliant.
2. Review your current brand architecture and apply a revised strategy to promote the brand, application, efficacy, claims, and on pack communications.
3. Utilise connected services to develop Rx and OTC compliance packaging with activation of digital communications as part of the overall strategy.
4. Ensure an effective project plan is in place, identifying all SKUs to be developed to ensure compliance to meet the 2020 regulations. This information will help to identify and manage the process steps of development, submission and print to pack timelines.
A pharmaceutical marketing business partner, such as SGK Health can support the process with subject matter experts to engage and deliver a complete end-to-end solution. Creative strategy and consultation with regulatory experts within the business enables us to develop clear, concise communications that support brand, regulatory compliance, and technical print aspects.
SGK serves seven of the Top 10 Global Pharma Companies —from design to print, we’re well-versed to develop compliant medication packaging for the mandatory regulatory requirements.
To learn more about the new Australian medicine label regulations, visit the Therapeutic Goods Administration website.
How Is Technology Supporting Healthcare Consumer Behavior?
This blog post has been contributed by Karin Bauer, VP Client Services, SGK Health
From passive recipients to active participants, our role in healthcare as patients and consumers has changed. Consumer expectations have changed, so how can we engage with increasingly savvy shoppers in this dynamic healthcare landscape?
Obviously, transparency and access to information have been factors in the changing healthcare world. We all have a better understanding of our health with the assist of technology, and we have the capacity to bring that knowledge into our doctor’s office to enable real-time conversations with them.
On a global, macro level, there has been a shift to value-based care, and now CMS is reimbursing providers and/or hospitals for better patient outcomes.
What drove this shift?
No surprises here: technology.
Now, instead of looking at how one patient is doing in a hospital, we have the capability to monitor an entire hospital to see the entire population health. Providers are now looking at how they can change their model to reflect healthier populations. The result we’re seeing is a lot of integration of people and data — expanding the opportunity for a big data healthcare system.
“For the eleventh quarter in a row, the U.S. health services industry witnessed over 200 deals.” – PWC LLP Q2 2017 Health Services deal activity report
In general, moving from a treatment model to a prevention model is less expensive, which is a huge motivator for the healthcare industry. On the other hand, this is shifting the cost of care. Providers need to provide better outcomes, otherwise they will not get the reimbursement, and in turn, we as consumers are seeing higher deductibles.
At the end of the day, as consumers pay more, they are also becoming more careful and discernable healthcare shoppers. Here are a few more ways consumers are responding:
- Embracing new technologies
- Being more selective in choosing care + care providers
- Delaying and forgoing care
“Behavioral science shows that people’s choices are driven not only by rational factors but also by a variety of societal, emotional, and psychological drivers.” - McKinsey, January 2010
Below, seven ways technology supports consumer behavior and the focus on prevention:
- Big data
- Genetic mapping
- Artificial intelligence
- Hand-held real-time on-demand Dx and solutions
- Wearables and bio-sensors
- Opt-in clinical studies in the cloud
Through data-driven care and metrics, we are also seeing a rise in new levels of care personalization and predictive modeling. Virtual visits and home care is a trend you may see more of in 2018.
From passive recipients to active participants, our role and expectations in healthcare as consumers and patients has been fundamentally redesigned.
Successful companies will leverage this change and make emotional connection with their brand a part of their broad strategy, involving every function in the value chain – from product development and marketing to sales and services.
About Karin Bauer: Trained in science and journalism, Karin discovered two developmental cancer therapies before honing her research skills to focus on telling compelling stories about products and organizations that move markets. Karin is a passionate advocate for break-through technologies that transform healthcare for the better. She has led in-house and agency brand strategy communications on healthcare products that have moved markets, and maintains strong ties to the research and health technology communities that are driving the future of healthcare.
7 Challenges Facing Pharmaceutical Packaging Today
The healthcare landscape is changing. With new levels of transparency, consumers have access to more information than ever. Advancements in healthcare technology allow consumers to actually bring in information to enable real-time conversations with healthcare professionals, sourced from electronic medical records, wearables, or smart devices.
On a global level, there has been a shift to value-based care, from CMS reimbursement for numbers of procedures, to reimbursement for better patient outcomes. Through EMR and EHR mandates, there lies new insight into care data and population health.
In general, healthcare is moving from a treatment model to a prevention model. However, this is also shifting the cost of care. Providers need to provide better outcomes; otherwise they risk not getting reimbursed.
In turn, we as consumers are being asked to pay more. As a result, consumers have become more careful, and discerning healthcare shoppers. Consumers are responding to this shift by shopping more and embracing new technologies. They are also more selective in choosing care and care providers, while delaying and forgoing care.
“For the eleventh quarter in a row, the U.S. health services industry witnessed over 200 deals.” – PWC LLP Q2 2017 Health Services deal activity report
Successful health and wellness brands know how to market to physicians, appealing to their expertise and their desire to deliver better outcomes for their patients. Now, they need to learn how to market to consumers, appealing to the most fundamental desire of all.
Like other consumer brands, such as CPG, automotive, fashion, and electronics, they need to learn how to create strong emotional bonds and brand identification to last a lifetime by considering:
- Package information
- Health authority regulations
Below, seven challenges facing the pharmaceutical packaging industry today:
Globalization. The push to globalize, to capitalize on huge marketplaces in rapidly developing nations — with this comes pressure to adhere to complex standards.
Regulations. Developing and implementing superior processes related to rapidly evolving labels and new regulatory regimens for information and anti-counterfeiting.
Economics. Downward price pressure due to broad governmental and economic factors is an ongoing challenge for the pharma packaging industry.
New-product cost. A shrinking new-product pipeline, with fewer blockbuster drugs and increasing new-product cost.
Speed-to-market. The need for speed-to-market and agility to capitalize on short windows of exclusivity.
Informed consumers. Consumers are paying far more attention to the health, nutritional, and fitness benefits of the brands they buy, using information they find on the internet, through social media, and on a growing selection of “clean label” products to guide their choices.
In response, sophisticated branding and product information are being implemented to pharma packaging to satisfy demanding OTC consumers and ever-more-informed patients.
Serialization and usability. The requirement for a clear serialization strategy driven by the Falsified Medicines Directive — not only do patients need the correct medication without the risk of counterfeit products, they need to know how to use the packaging and have a clear understanding of how it works.
Brands still need to build physician awareness and trust through product-centered information. But to win with empowered consumers, they must also provide brand-centered relevance, based on insight into consumer behaviors, perceptions and preferences.
Beyond just behavior changes in terms of cost, behavioral science shows that people’s choices are driven not only by rational factors, but also by a variety of societal, emotional, and psychological factors.
5 Key Tips for Pharmaceutical Companies Outsourcing Artwork Services for Packaging
This blog was contributed by Stephen Marshman, Business Development Director, SGK.
While packaging and labeling errors account for more than half of product recalls; the bar for pharmaceutical packaging is set much higher than other market sectors — and for good reason. When errors could potentially cost a life, the pressure for accuracy in the life sciences category is a priority.
To avoid the many packaging hurdles facing pharma companies today and to streamline labeling and artwork production, follow the 5 steps below:
1. Find the right partner. Make sure you partner with a company who has done this before.
Using a third party provider to create your packaging artwork is not a particularly new concept. Lots of pharmaceutical companies, big and small, are already doing it and some have been doing it for years. That said, comparing the pharmaceutical industry with other industry sectors, the outsource market is still relatively immature and the number of specialist agencies providing this service isn’t large.
The specific industry requirements for pharma does mean that the bar is set higher and there are even fewer artwork suppliers who have proved their capability by providing this service for multiple pharma companies. It's a big change and comes with risks. You don’t want to be working with an agency that is doing this for the first time!
2. Know your options. Look for cost savings beyond the obvious.
Pharma companies usually go about the process of looking at outsourcing as part of a procurement-led cost-reduction strategy. This makes perfect sense and while the internal head-count reductions are understandably front-of-mind, to not look beyond this can be a blinkered, somewhat limited approach. Often, if sourcing teams across the organisation can be more joined up, there are significant opportunities to be found by looking into adjacent areas such as print. Here there can be big savings made by eliminating duplication on the part of printers who are often performing (and charging for) their own pre-press activities.
Over and above this, there are the bigger picture savings that can be gained by switching to a centralised, harmonised way of working with one or two external suppliers. This shift in model can drive huge efficiencies across the business in areas ranging from process simplification to streamlining materials and component formats. Sometimes harder to quantify, it’s these hidden costs that often yield the biggest savings of all.
3. Look to internal stakeholders. Recognise the importance of doing good internal communication can't be underestimated.
Due to the way sourcing projects work, especially those with sensitivities around areas such as redundancy, there is often a very small number of people in your organisation involved in the process until you have chosen your partner and announced the intention to outsource. This is a pivotal moment in the success of the project. Artwork touches multiple functions in an organisation and is likely to impact hundreds, if not thousands of your employees.
When the switch is flicked and the project shifts from something a handful of people were aware of, to one that affects a large number of your people, getting the messaging right and making sure people can understand what you are doing and why, is critical. Clear, timely and appropriately targeted communication and good project management are as vital as any other factors of getting an implementation right.
4. Make the transition. Be realistic about the pace of change.
No one should think getting this right is easy. Companies actually get it wrong in very different ways. This is a major transformation of an essential business process. Trying to do it too quickly, to meet an arbitrary deadline or because it feels like the right amount of time, could be a disaster. No two organisations are alike but there will be factors around scale, complexity and organisational culture that will help you plan how to optimise your critical path and decide how you will phase an implementation. There may be business-critical factors that impact your timeline too. Just as potentially dangerous as moving too fast is making the transition overly drawn out.
Being naturally risk averse – and there is certainly nothing wrong with that – some pharma companies will plan for a transition to be phased over many months or even years. This can also cause problems. The period of transition, or that time when you are effectively running two processes side by side, is one of uncertainty and sometimes a degree of duplication or even confusion. The optimal rate of change will be one that moves you to the desired future state as efficiently as possible, with all stakeholders aligned with the plan and without any compromise on risks.
5. Commit to success. Ensure the organisation is ready for the change to ensure success.
Outsourcing artwork should never be a box-ticking exercise. Your company shouldn’t do this because it helps meet a target that a senior executive set without them really understanding what making that change would entail. It can be a highly effective tool in helping unlock value, not just in the artwork process but across the end-to-end packaging supply chain. It can also be a powerful enabler that helps companies achieve a lot more than simply having their artwork created by a third party, rather than an in-house team.
However, if key functions across the business don’t fully appreciate this larger opportunity and what it will take to deliver it, and deliver it well, it is highly likely that the project will either fail, or at the very least, create noise in your business throughout a protracted and disruptive transition. Getting this right can bring many business benefits to the organisation. Making sure that the company understands what these benefits are, and that the organisation is ready to commit the time and the resource to make it work, is critical to your success.
From brand artwork, to package inserts, to serialized codes, a pharma product that can’t fail demands processes that help you get everything right the first time.
About Stephen Marshman: Stephen has twenty years’ experience in the artwork and packaging sector having begun his career with graphics specialist SGK in 1997. Today he works as a Business Development Director, focused on helping pharmaceutical companies implement best practice artwork processes. Stephen played a pioneering role in the development of SGK’s unique approach to working with pharmaceutical clients more than fifteen years ago and remains a key part of the global team today. Earlier in his career he enjoyed a range of client-facing roles, including working on-site at pharmaceutical clients’ facilities, providing him with valuable first-hand insights into the specific artwork requirements of the sector.
Best Practice Approaches to Implementing a Global Artwork Model
The global pharma market faces unprecedented complexities and pressures regarding the packaging and labelling of medicinal products. When your packaging and labelling can’t fail, how can you execute with confidence?
SGK will be exhibiting at the Pharmaceutical Packaging and Labelling Summit 19 – 21 June, 2017 in Zurich, Switzerland.
SGK plays a key role in assisting clients across a range of critical activities; from helping organizations to define their marketing supply chain strategies through to the delivery of packaging design and artwork production.
We are experts and innovators in packaging production and graphics processes and our technologies drive precise execution of printed materials in highly regulated, validated contexts worldwide. We also create and design over-the-counter brands and other shopper and patient-facing communications.
Also learn more at the summit about how Matthews Marking Systems can provide optimised solutions to the pharmaceutical sector’s current serialization challenges.
About Pharmaceutical Packaging and Labelling Summit: Pharma IQ’s Packaging and Labelling conference attracts over 100 packaging, labelling, and artwork experts from across big and small pharma, who come together to share case studies, discuss the current challenges, and most importantly find solutions! For more information, visit: https://packaginglabelling.iqpc.com
6 CPG Trends That Are Shaping Pharma Brand Marketing
The nature of branding has been redefined. By understanding today’s big consumer goods trends, pharma brands can position themselves for greater success, says Bruce Levinson, VP of Client Engagement at SGK.
In his recent BrandSquare Live Session, CPG Mega-Trends Influencing Pharma Brands, Bruce discussed six CPG mega-trends that are creating new risks…and new opportunities. Are you ready?
1. Global Consumerism – Today, access to international travel, cuisine, fashion and sports have created a new global consumer - one with a taste for the world beyond their doorstep. Millennials in particular are challenging accepted norms and not simply buying into the brands and products that their parents did. The range of products available to them is much more diverse, borrowing flavors, ingredients, raw materials and even philosophies from all corners of the globe.
As with CPG, patients are challenging norms in the pharmaceutical sector and are at the center of new healthcare models. While historically, pharma has focused on developing blockbuster drugs, the criteria for success has changed today. Patients are now equipped with more information at their fingertips and are actively involved in managing their own health. They’re considering remedies from around the world that go beyond conventional medicine, such as alternative medicine and traditional Chinese medicine.
2. Celebrating Authenticity – This is demonstrated by brands with a compelling, lasting narrative: the brands that don’t change with the whims and fancies of the latest fads, even newer brands that offer something distinctive and not easily copied.
The pharma sector is massively targeted for counterfeiting, which accounts for annual losses estimated at $75 billion. Packaging is a key part of the strategy for protecting the authenticity of the brand and ultimately patient safety. Pharma brands are leveraging multiple security techniques with varying degrees of success. Covert features enable brand owners to identify a product’s authenticity.
3. Sustainability Consciousness – Millennials don’t just know more about sustainability, they care more and often vote with their wallets. And today sustainability isn’t just about saving the planet. It’s about how a company and its brands interact with resources, people and even ideals. Sustainable sourcing, fair trade practices and even social corporate responsibility have become a new focus of packaging and marketing materials.
For pharma the act of putting a product in our bodies creates a much higher degree of personal importance than perhaps ecological sustainability. OTC consumers favor claims supporting purity and “natural-ness”. For instance BFS (blow-fill-seal) technology has gained market focus in recent years for its multiple sustainability advantages. With BFS, there’s no need to purchase or stock a range of pre-fabricated containers and sterilization is not required.
4. Specialization of Everything – Products have become over-engineered, providing perhaps more than we really need. The “Good, Better, Best” portfolio has evolved to include Super-Premium, Gourmet, Free-Form and Industrial. In the pharma sector, this has resulted in specialized “compound” customized medications. This practice is widely recognized as medically necessary. Prescriptions are based on patients’ needs under supervision.
5. Consumer Proactivity – Consumers are seeking information and guidance from brands in planning their family, finances, beauty and, of course, their health, making on-pack and on-line messaging strategy more important than ever. Patient-centric healthcare has been characterized by a number of trends as well. Passive patients have been replaced by patients who are engaged, which means pharmaceutical companies must take time to understand what these patients need.
6. Make It Easy – Consumers are faced with so many choices, they won’t waste their time and money on brands that make life too hard. What works: Fast-acting, convenient formats, on the go. Make it simple for them to navigate between flavors and functions. Research indicates that in most cases, packaging can contribute to improving adherence levels, which are shockingly low among patients with chronic conditions. Patients’ perception of their medication needs to change and innovative packaging can help address these areas.
Learn more about the consumer goods trends that are influencing how pharma brands are managed and marketed. Watch Bruce Levinson’s BrandSquare Live Session recording on YouTube!
Important Indian Pharma News Meshes With Recent SGK Patterns Article
In the current issue of SGK Patterns: Emerging Markets, Converging Opportunities, SGK explains the unique role of India in the world pharmaceutical market – how several decades of freedom from patent law gave it an edge in R&D and in global market share, as the leader in low-cost imitation drugs. A recent important news story from India suggests that the title of the Patterns story – “Every Challenge is an Opportunity: Manufacturing and Marketing Pharmaceuticals in India” – was on the mark:
The news of April 1 was that the Indian high court had struck down a petition by a major pharmaceutical company for patent protection of its very successful cancer drug. The pharmaceutical company said the drug was covered under Indian law that says drugs patented before 1995 are patent-protected; the court ruled that the version now being copied is different from the version the company had patented in 1993.
The ruling related to just one drug, but press coverage showed that it could have huge impact. Pharma representatives felt that the ruling was a step backward in progress toward Western-style patent protection that India began in 2005 with updated laws. And that it would prompt other developing countries to swing against patent protections going forward.
Public health officials were glad for the ruling, because the drug in question costs considerably less in generic, making it much more available to sick people worldwide.
The news is a perfect example of the complicated nature of world pharma. How do courts and governments balance the need for intellectual property protection, product research and the availability of affordable medicines? Here is The New York Times’ account of the Indian court’s judgment; read it along with Every Challenge Is an Opportunity: Manufacturing and Marketing Pharmaceuticals in India. You’ll see that the article could also have been entitled “Every Opportunity Is a Challenge.”