If you are an Rx regional sales director or a product marketing manager, I have a somewhat provocative question for you:  How exactly are you planning your 2014 Medicaid strategy?

I ask this because as you look over the Medicaid landscape for next year, there is more than a little uncertainty at hand.  With Medicaid about to become the basic health care delivery mechanism of the 2010 Affordable Care Act, otherwise known as Obamacare, you would think this might be a simple matter of reviewing the new federal law for guidance. But if that’s the approach you are taking for your 2014 Medicaid planning, let me be the first to tell you, you are going down the wrong path.

Obamacare is premised on the idea that federal government and state governments will cooperate in the delivery of healthcare to an estimated 40 million new Medicaid patients starting on January 1, 2014, with sign up for these new services scheduled to begin on October 1, 2013.

That is all well and good, so far as a reading of the law goes.  But when you begin to dig into how the states are actually implementing Obamacare, you soon realize the launch of this new law is not going as smoothly as the framers of the measure had hoped.

As of this writing, and according to the Kaiser Family Foundation, there are 26 states that have said absolutely “no” to state exchanges envisioned by Obamacare and are defaulting to a federal exchange; 7 that have said “no” to parts of Obamacare and have negotiated “Partnership Exchanges” with HHS; and only 18 that have declared they will establish state-based exchanges, and cooperate with new law.

If Kaiser is correct in these assessments and given the current US population of about 313 million, this means that approximately 56% (177 million) of Americans live in states that have said effectively said “no” to Obamacare; 10% (32 million) live in states that have rejected parts of Obamacare; and only 33% (104 million) live in states that will have access to Obamacare’s state exchange offerings.

If these statistics startle you, they should.  Thinking about your 2014 “numbers,” how will you manage this situation nationally?  In particular, what will happen in those states that are “defaulting to the federal exchange?”  Here are two key examples you may want to focus on for your answers.

Florida

Florida’s current population is about 19 million.  Right now, 3.3 million Floridians (approx. 17% of the state) are enrolled in FL Medicaid.  It’s estimated that another 1.3 million Medicaid recipients will be added to Florida’s Medicaid rolls once Obamacare is implemented.  This creates a potential situation in which nearly 25% of Florida’s total population is scheduled to be receiving Medicaid Rx care after January 1.  Any Rx sales manager or product marketer who is responsible for the State of Florida has to take notice of these numbers.

So how is the implementation of Obamacare going in Florida?

This past winter, Florida’s governor, Rick Scott, a Republican, publicly broke ranks with his Republican Governor Association colleagues, and announced that he was seeking a “deal” for Florida that would accept the essence of Obamacare, i.e., the federal financial support, while adopting a 100% federal provision of insurance services, all of which sunset and be reviewed after three years.

Seemed like a done deal. But when Gov. Scott took his concept to the Florida legislature, he encountered stubborn resistance from the Florida House of Representatives.  In the end, the governor gave up and the entire Obamacare package was shelved. Florida, it appears, will default to whatever the “federal exchange” may turn out to be.

So, how as a sales & marketing executive with responsibility for Florida do you plan your sales and/or marketing strategy in this huge, heavily Medicaid impacted state?  What drugs will be covered in the “federal exchange?” Will only one drug per category be covered, per the earlier recommendations of the Essential Health Benefits finding put out by HHS? How will you get your drug covered for Florida Medicaid in 2014? How will you get reimbursed? From the state or the feds? And at what rate? Right now, nobody knows the answers to any of these questions.

Let’s look at another important example that is being impacted by Obamacare: Texas.

Texas

Texas is now the number two most populous state in the nation with an estimated 2012 population of over 26 million. It’s also one of the fastest growing states in the nation.  Given all of this, I don’t think it would be an overstatement to suggest that every Rx sales and marketing director in the country wants a piece of Texas.

So let’s consider the impact of Obamacare’s implementation here. Currently, Texas Medicaid beneficiaries number approximately 5 million individuals, or about 20% of the population. An estimated 2.6 million beneficiaries could be added to the Texas Medicaid rolls under Obamacare. That would total 7.6 million people, or about 29% of the State of Texas population.

Unlike Florida, however, Texas has been a steadfast “no” in cooperating with the federal government on the implementation of Obamacare from the start. Therefore, Texas had no debate about setting up a state exchange for new Medicaid patients. Instead, like Florida, a new federal exchange is supposed to be put into operation for nearly 8 million Texans by January 1, 2014.  How this will be accomplished in Austin is unclear at this time.

Again, as regional sales directors or product managers for Texas, how do you plan on “making your numbers” in this huge market for 2014?

Planning Elements for Medicaid Sales & Marketing in 2014

I could go on from here with the specifics of each “no” state, but I think you get the picture.  Just Florida and Texas, alone, both among America’s most populous states, account for nearly 10% of the estimated 40 million total Medicaid expansion this new law is supposed drive come January 1, 2014.  These two states by themselves stand to generate massive Rx sales that will impact anyone’s national sales or product marketing plan.  However, both are essentially blank pages today in terms of how your products will be included on a formulary, what the reimbursement rates will be, who will pay you for their dispensing, and all the rest that goes into making money in a state Medicaid Rx program.

And the same is true for the other 24 “no” states. Nobody has answers. Overall, you are essentially in the dark as to how to plan for about 22 million new beneficiaries with drug coverage.

So how do you to manage your sales and marketing for Medicaid Rx patients in this 2014 environment?

First, you are going to need much better intelligence on what every state has decided to do with its Medicaid Rx program than you have ever had before.  Given 40 million new potential, paying customers, you would be foolish not to demand the best, most complete information available on each state.  If you don’t have that deep info, frankly, how can you establish sales and marketing goals for 2014?

Second, you will need to figure out how each state will actually administer Obamacare. Will it be by default to the federal exchange; the negotiated “partnership exchanges;” or through separate state exchanges? And depending on which policy the state has chosen to follow, what will that mean to you? Every state will do it differently based on their medical culture, the state’s finances, and the level of cooperation medical providers offer in each state. Understanding all of these factors will be imperative.

Third, I would suggest this situation is anything but static (some states may quickly walk away from Obamacare after it starts; others may decide to join; still more could come up with entirely unexpected solutions for their populations).  You will want onsite staff in many of the major state capitols just to keep track of all of this. That could be expensive, but how else are you going to stay on top of all of these developments?

In short, sales and marketing execs are going to have to think way outside of the box in 2014 if they believe their Rx company will enjoy the financial benefits of Obamacare’s new Rx coverage.  And this is certainly not to say that the prospects for monetary gain don’t exist. They clearly do, but only if you can figure out how to convert on this Obamacare opportunity in each state.

All of this said, I believe this particular reimbursement opportunity will be unlike any other the US drug industry has ever faced. The reimbursement uncertainly, intrusive politics, and the shear market chaos that is likely to result will be challenging. But it’s also equally clear that if you stand around, waiting to see “how things develop” under Obamacare, you run the risk of substantial Rx sales and marketing losses for 2014, and beyond.

The choice is clear. You have to engage, come what may. So, what’s your Medicaid Sales and Marketing plan look like for 2014?

Tom Norton is principal at NHD Smart Communications. He can be reached at tnorton@nhdcomm.com

For CEOs who have spent long years and countless funds building a solid pharmaceutical brand and life-changing drugs, discovering defamatory remarks about your company online can come as quite a shock. Even worse, the negative comments about the company are often published on social media and popular review websites that rank high in search results, so everyone curious about the company sees them. And because they rank so high, these complaints often show up in search results years after the problem is resolved, diminishing your reputation both immediately and over the long-term.

A poor online reputation also impacts your revenue. Several years ago I met with a company with a severe online reputation problem — 7 out of the top 10 search results about their company were negative. After carefully reviewing their rankings and revenues, I estimated their poor online reputation was costing them over $1.5 million in sales per year. How your company is perceived online dramatically affects your bottom line.

So what can you do to protect and insulate your company from the far-reaching effects of a few complaints others are posting online about you?
Start by understanding some basics:

What is “online reputation”?
Your reputation online is based mainly on the top 10 to 20 results in a Google search on your company name. Your reputation suffers when any of these results are negative reviews or complaints about your company, customer service, or drugs, especially if they are published on multiple complaint sites. If the results are positive or at least neutral content about your company and products, prospects perceive you as a company worth doing business with or learning more about.

Where do negative comments come from?
If someone really wants to complain about your pharmaceutical company or products, there are plenty of review and complaint sites for them to use, such as scam.com, ripoffreport.com, and complaintsboard.com. Sites like these don’t check for accuracy, don’t usually remove a complaint if you request it, and they tend to rank very high in search results. So if someone complains about you on one of these sites, expect it to show up in search results, even years after the issue was resolved.

How a few negative comments can hurt your online reputation
A complaint or two online seems like it shouldn’t matter, but it does. Even just one negative result near the top of a Google search on your company or products can scare away potential customers by making them think twice about your products.

On top of that, if a search result promises to reveal the dirt on your company, prospects are far more likely to click that result. After all, they are researching you, and your products could drastically affect their lives.

Once you understand the basics, you can take steps to manage and protect your reputation so you are not at the mercy of your critics.

First, accept that there will be negative content about you. Everyone has the right to complain. Short of outright slander or libel, there’s not much you can do to remove negative comments about your company online.

Instead of getting frustrated or responding in the heat of the moment, just accept the fact of negative online content. Sometimes you’ll need to respond, especially on social media, to take care of customer service issues. But most of the time, it’s better to not respond at all.

The reason is that search engines give high rankings to websites with relevant, regularly updated content. Every time you comment on a website, you contribute relevant, updated content. So if you get into a back-and-forth situation with a reviewer, Google sees a lot of relevant, updated content about the company and ranks the website higher for searches on your company name, making it even more likely that everyone will see not only the negative review, but the argumentative way you responded.

On the other hand, if you simply accept the fact and move on, the review will slowly lose its high ranking and you can work on pushing it down.

Second, focus on getting positive content. The goal of pharmaceutical online reputation management is pushing negative content off the first two pages of a Google search. You do that by publishing lots of positive content and getting it to rank higher than the negative results.

That means you need to always be looking for, gathering, and creating positive content to update your websites, blogs, social media, and other places online. Publishing that positive content in multiple places online helps you gain control over more search results, so you might create several websites for different purposes and audiences. For example, you might have a website for doctors and healthcare professionals, another website where you publish news and drug trial information, and websites for individual drugs and product lines.

Third, push positive content higher in search results. The higher you can push your positive content, or at least neutral content like a Wikipedia page, the lower negative content will appear. If you can push down complains and negative reviews to the second page of a Google search or lower, they may as well not exist since most searchers don’t look past the first page.

The best way to edge out the negative content is to perform search engine optimization (SEO) on your positive content. The most important things to do for proper SEO include:

• Use your company name and other important keywords throughout your website’s content and in meta titles and descriptions, image names, image alt tags, headings, and subheadings.
• Update your website often and regularly with relevant, positive content to encourage search engines to crawl your pages more often.
• Link out to trustworthy, reputable websites to create a better user experience.
• Get trustworthy, reputable websites to link to your website so Google will think it is popular and relevant to your company name and keywords.

Of course, there’s more you can do to protect the online reputation of your company and your products, but these basic steps will get you started in the right direction.

For information on accentuating positive content for your reputation, read Don’s article in the March issue of Pharmaceutical Executive Global Digest.

About the author
Don Sorensen is founder of Big Blue Robot, a reputation management consultancy.

The UK’s Royal Pharmaceutical Society has joined forces with a number of other organizations, including the Association of the British Pharmaceutical Industry (ABPI), to issue new guidance on medicines optimization.  Sir Bruce Keogh, Medical Director of NHS England, says it could be revolutionary.

The guidance is driven by increasing recognition of how many medicines just aren’t used as they should be; wasting money (some £150 million in primary care alone) and effort from across the chain of industry and professionals involved in developing, delivering and prescribing medicines. Underlying that it’s also getting a higher profile as the debate and efforts to quantify real world effectiveness ramps up; companies are under pressure to show just what patients and the system that pays are getting for each £ spent on medicines. And if patients just don’t take their medicines the way they are supposed to, that’s a crucial break in the chain for companies who must show just what the benefits are of their products in real life.

According to the guide medicines optimization is “about ensuring that the right patients get the right choice of medicine, at the right time”.  That’s been a mantra for a while, so what’s new about this?  The guide says that the differences are about focusing on patient experience and multi-disciplinary team working not seen before.  For industry, their responsibility lies in “transparent and value for money partnerships with the NHS that help secure better outcomes for patients”.

There is much to welcome in the document, and presumably the ABPI worked hard to ensure that it picked up on:

•    The NHS Constitution and patients rights to NICE approved treatments
•    Automatic inclusion on formularies of NICE approved treatments
•    Costs are lowered by avoiding avoidable harm and avoiding admissions to hospital

And dis-investment features too; where treatments are of limited clinical value, they should not be used.

But where is becomes more difficult to claim revolution is in whether the guidance will be picked up and used on the ground.  The spirit of the guidance has been around for some time, but the guidance also stresses the importance of measuring the impact.  That’s could be a real driver, if busy professionals take up the challenge…..

Leela Barham is an independent health economist.

The global market for biosimilar drugs has been forecasted to be worth $2.445 billion this year, according to a new report by British market research specialist Visiongain. The growth represents a 20% increase from last year and accounts for approximately 2% of the overall biologics market. Moreover, the global biosimilars market is expected to experience a steady growth over the next 10 years, driven by worldwide launches of such products, particularly in the EU and US.
The report predicts that the biosimilar monoclonal antibodies (mAbs) and insulin submarkets will see the fastest growth, with these products making up 57% of the global biosimilars market by 2023. Last year itself, South Korean biotech firm Celltrion and Hospira, a US-based pharmaceutical company, submitted regulatory filings to the European Medicines Agency (EMA) seeking for approval of their biosimilar version of the mAb infliximab. Visiongain anticipates that these products will be launched in the EU in 2014.

The mAbs have the strongest R&D pipeline in the biologics market according to the report. In fact, we can expect to see a range of next-generation technologies pushing mAb therapeutics into newer areas such as solid tumours, cardiovascular and neurological disorders.

There is also major growth opportunity for biologics in the treatment of diabetes. New fusion proteins are set to join Novo Nordisk’s insulin degludec (Tresiba), which is a new-generation basal insulin with ultra-long duration of action of more than 42 hours, as well as other novel insulins on the market in the near future.
However, mAbs and insulins are not the only biosimilar submarkets projected to experience growth. Biosimilar erythropoietins and filgrastim products are already available in several developed markets, including the EU and Japan. Despite the limited revenues achieved with biosimilar erythropoietins and filgrastim products compared to their reference biologics, Visiongain believes that the launches of these biosimilar products in the US will drive further growth from 2014 onwards, as will the worldwide introduction of second-generation filgrastim (pegfilgrastim) and epoetin alpha (darbepoetin alpha) biosimilars.

Pharmaceutical industry analyst James Evans commented in a press statement, “Biologics were one, two and three in the top ten drugs of 2012. People talk about the biotech revolution, but biotech is now one of the dominant, established powers in the pharmaceutical industry.” He noted that all the main biotechs have either been acquired by Big Pharma or become major players in their own right.

Evans added that the next big shift would be when biosimilars begin to penetrate the market. “Once the EU’s new regulatory pathway for biosimilars has been established, we can expect the major markets to be inundated with biosimilars and biobetters. The entry barriers for bio-manufacturing and bio-processing have been greatly reduced, and even the suite of technologies that built the mAb market, from phage display to transgenic mice, are now off-patent and accessible to any company that’s interested. And biologics are going to become so prevalent that every major company will be interested in having a stake in that expanding market.”

Richard Lang, a pharmaceutical market analyst at Visiongain, said in another press release that many companies are interested in entering the biosimilars market and have invested in this field, given the simpler route of launching such drugs compared to developing novel biologics. Lang however pointed out that not all biosimilar development programs will be successful. “Biologics and biosimilars are large, complex molecules requiring long and expensive development and manufacturing. The recent release of development guidelines by regulatory agencies in markets worldwide will increase the success rate of biosimilar development.

However, commercializing biosimilars is as challenging as developing them. Companies will need to brand and market their biosimilars in a similar way to novel drugs, engaging key stakeholders such as doctors, health care payers and patients, to achieve high market penetration.”

Emerging markets, particularly China and India, have been leaders in biosimilars, accounting for the majority of global revenues for biosimilars in 2012, whereas the EU, US and Japan made up 20% of the market last year. But for the next 10 years, Visiongain predicts that the developed markets will see faster growth than the emerging markets, driven by patent expiries on blockbuster biologics during 2013 to 2017.

The problem we see with the polarity of views is that both sides seem to be cranking up the extrapolation machine and use single studies/data points to draw broad conclusions to gin up opinions about ACA’s success or lack thereof. With respect to investing, uncertainly caused by media/pundit noise often depresses valuations in the short run. We suggest investors avoid the extrapolation machine and stick to observing fundamentals and fact. In the context of healthcare, as we see it, this means focusing on a double bottom line: financial return potential and companies who create value improving quality or meeting a need.

The Kaiser Family Foundation (KFF) recently released a study that showed that 42% of Americans are unaware that Obamacare (the Affordable Care Act) remains the “law of the land.”  News like this seems to us, to act as a Rorschach test on how observers feel about the law. Considering 50% of Americans can’t identify New York on a map we tend not to read too much into these polls. However, according to the logic of extrapolation, since we know that the ACA remains law, we are in the elite 58% (it’s about time we made it into the elite of something).
In almost parallel to the KFF news, the New England Journal of Medicine published a follow-up study of the “Oregon experiment.” For those who haven’t been following closely, the study found that previously uninsured people who were enrolled in Medicaid did not see an improvement in clinical measures when compared to those who remained uninsured. The study did seem to show a reduction in the amount of financial distress for the insured however.

Another contentious study, another Rorschach test (example, example). In light of the fact that for most practical matters ACA doesn’t really get going until 2014, use of the extrapolation noise generator approach smacks of a lack of analytical rigor in our view. We will know soon enough how the program is doing… exchanges start enrolling on 10/1.

As investors, we should state upfront that we tend to give more weight to financial returns than what the philosopher-kings might call the political context. So what caught our eye in the Oregon study was that Medicaid recipients had higher healthcare utilization rates (and associated costs) than the uninsured. The connection between gaining insured status and healthcare utilization should not come as a surprise since there is a very extensive literature elucidating this connection.

We have noticed that many in the political community, especially where it pertains to entitlements, have taken an absolutist utilization=bad view of the world. At Poliwogg we take a more nuanced approach. We view healthcare expenditures not as a cost but as the creation of an asset. In our framework, utilization can be categorized as generating either a positive return or a negative return depending on the outcome. If the expenditure creates additional value it is good, if it does not than it is bad. We would take a good pharmaceutical over a bad diagnostic test any day despite the former often being more expensive upfront.

To be fair, it is not always easy to determine a priori whether utilization will have a positive or negative consequence longer-term. And it should be noted that the system does have significant inertia hard-wired into it (prior mis-allocation of resources, a mal-incentive based reimbursement structure and asymmetry of information, among other things) which needs to be overcome. Nevertheless, there are signs that some things have changed recently to offer some glimmers of hope of a possibility of value creation and system enhancement. Like it or not, ACA is a change-agent and it will alter the status quo. The impact of improvement in technology and telecommunication, which allows for more real-time observation of events and predictive analytics, is first being felt. And, given the downward trajectory of utilization connected to the recent economic downturn it’s a pretty good supposition that healthcare costs (after many decades of rising) are finally starting to alter behavior on the part of patients and providers.

With respect to investing, uncertainly caused by media/pundit noise often depresses valuations in the short run. We suggest investors avoid the extrapolation machine and stick to observing fundamentals and fact. In the context of healthcare, as we see it, this means focusing on a double bottom line: companies with financial return potential (at the appropriate risk level) and companies who create value through innovation either by improving quality or meeting a need (especially true in the case of therapeutics for many currently poorly-treated diseases). If investors do this they can let the extrapolation machine work for them rather than exacerbate the problem.

Morten Hjelmsoe

One of the things that we’re hearing a lot about right now is big data. We’re told that we’re entering an era of big data that will come to transform business and government services alike. For data, so the thinking goes, the bigger the better. But, asks Agnitio’s Morten Hjelmsoe,  is this always the case?

There’s no doubt that big data is very useful. As organizations create and store ever more digital data, they can use it to make informed decisions on everything from product inventories to employee morale. And, through the growing use of sensors embedded in products, it’s increasingly possible to offer novel after-sales services and even proactive maintenance. That way, customers may not even notice as preventative measures are taken before a failure occurs.

It’s also thought that big data will enable an ever-narrower segmentation of customers and therefore make possible more precisely tailored products or services. But it’s here that I take issue. While we certainly do want better segmentation, crunching vast data repositories might not be the best way to get it – particularly in the pharmaceutical industry.

Big data, old paradigm
The problem is that big data actually operates using an old-fashioned paradigm. This says that we need to deal with people in groups. So we start off with data about everyone and then look for patterns; effectively chopping the data down to size and creating some more manageable groups at whom we can target our communications.

If you think about it, this big data approach is actually a little odd. In effect, we are taking data from individuals, squashing it together into a big pie and then chopping it into slices. Why would we do this if individuals have already told us what they are interested in? The process makes it less individual and therefore less relevant. Why deal with groups at all?

Small is beautiful
The reason that companies need the big data is because they don’t have the “small” data. But pharma actually does!

Like no other business, we physically see our customers, if not every week but then at least several times a year in most markets. I know of no other B2B industry that has such frequent face-to-face interaction with its customers.

This customer contact is a tremendous resource but one that until recently we haven’t been able to tap; we loaded up our reps with information but they come home empty. That individual “small” data was lost. But not any longer.

New digital technology allows our sales force to understand each healthcare professional’s personal needs and interests, keep track of it, and respond. In effect, we now don’t need to force fit customers into any kind of group. This means we can give them highly relevant information. And that means higher value for the customer.

So get your reps into play. As an industry, we are in the best position to focus on the individual and we now have the tools to make it happen. When it comes to data and the pharmaceutical industry, my advice is to go small and think big.

Morten Hjelmsoe is founder of Agnitio.

Much of the excitement is linked to the imminent advent of Europe’s first real European patent. After decades of failed attempts, by the beginning of 2014 the European Union will finally have a ‘unitary patent’ — a system offering a single patent valid across all the member states (or nearly all — two member states have been more excited about the prospect of sabotaging it). For its many supporters, the unitary patent offers real advantages. Probably faster, certainly cheaper, and very much easier to manage than the patents available under the current patchwork of patents granted by national authorities or patents granted by the European Patent Office and requiring subsequent national validation.

The attractions are evident of securing a patent across most of Europe for just €4,725
(UDS$6, 180) instead of the €36,000 (UDS$47,100) it typically costs today, and being able to obtain it with a single application, and just in English, French or German (instead of multiple applications or validations subject to local language rules). In addition, it will be backed by a new international court specialized in patents, empowered to give rulings rapidly, and across every country where a patent is disputed — instead of parallel litigation in national courts leading to inconsistent rulings.

The “sabotage” attempts came from Italy and Spain, the two member states that have consistently held out against a Europe-wide system, largely because they feared negative effects on national innovation from the exclusion of their languages from the new system. They mounted a challenge at the EU’s own court against the creation of a mechanism they object to. But the court threw out that claim in April, ruling that the 25 countries could lawfully go ahead with their plan — particularly since Spain and Italy are free to join it if they so choose.

Even so, there are concerns about how the new system will work in practice. For all the simplicity of the underlying concept, its implementation is necessarily complex. As lawyers and accountants working for the innovative drug industry probe the detail, there is still a lack of clarity about precisely what it can and cannot do, and precisely how much it will cost.

There are concerns among generic manufacturers too. They do not want to see easier patent protection resulting in increased limits on competition.  That, they argue, could have a perverse effect on the EU’s sacred principle of a single market — or internal market, as the jargon terms it. “It is imperative that there is a balance in the rules between the ability of patentees to enforce their rights and the principles of the internal market: freedom of movement and competition”, insists the European Generic Medicines Association in an assessment of the plans for implementing the new system. It is anxious to secure fair competition, and to ensure that generic companies have a voice in decisions on disputes with originators, “without compromising legitimate enforcement of patent rights.” So there should be no easy route for originators to delaying tactics on generic entry, unless a court has duly assessed the validity of the patent.

So between now and the start of next year, a fever of expectation will be matched by a feverish search by all sides to get the best out of the new system. Meanwhile, alongside the moves on the unitary patent, further excitement is sweeping through the world of intellectual property over broader questions of just who should be making decisions on what a patent can and cannot do. Mirroring in some ways the issues raised by generic drug firms, this is emerging as an institutional battle between competition authorities and patent authorities, and it is taking place simultaneously in Europe and in the USA. It goes much wider than the drug industry, as demonstrated by recent decisions by the EU competition authorities questioning the scope of mobile phone patents. But the consequence is that, by a fine irony, just as getting a patent is about to get easier in Europe, hanging on to it may be getting harder.

Plenty of excitement still to come!

Peter Houston

You know this: digital marketing means you have the potential to get your message in front of more people than ever before; search and social media offer reach on an unparalleled scale. According to global internet analytics firm Comscore, there are 13.7 billion searches conducted on Google every month. With 60% of US consumers saying they looked for health information online in the last year, that’s a lot of potential patients.
The problem is, that reach is available to everyone else from top-10 pharma to your local Deli: We’re all publishers now.

Actually we’re not all publishers, we’re all authors. Publishers — certainly in the traditional sense of the word — would never allow most of the content on the Internet out of the slush pile. And it’s the public accessibility of that slush pile that might just provide Pharma with its best opportunity to be heard above the noise.

Content marketing — the art of creating and distributing relevant and valuable content to attract, acquire, and engage a clearly defined and understood target audience — is being hailed as the brightest hope for marketers desperate to cut through the Internet’s clutter. So far so good – Pharma has been producing quality, expert-led, evidence-based content for ever.

If you read some of the content marketing blogs you would think these geniuses had just invented the concept. But content marketing has been around almost as long as marketing.

• John Deere, America’s favourite tractor manufacturer, released the first customer magazine in 1895
• Guess what brand of flour my mother-in-law has on her kitchen shelf. Here’s a clue – she swears by her BeRo Flour cookbook first published in 1923 and now in its 40th edition.
• Have you ever wondered why the world’s leading restaurant guide is named after a tyre manufacturer? Back at the turn of the last century Michelin published its first restaurant recommendations to give drivers a good reason to burn more rubber.

What is new is the importance marketers are placing on real value delivered through content. Possibly the biggest reason for this new focus on quality is that Google, the daddy of web search, got tired of people gaming its search algorithms with sub-standard content

To combat SEO tactics that had more to do with keyword stuffing than content quality, Google changed the rules of the game with its Penguin algorithm, introduced this time last year and already headed for its third update. I won’t even begin to pretend to understand how Google’s algorithms work, but I do know they are focusing more and more on the quality and ‘shareability’ of content to improve the search experience and this puts content marketing firmly in the frame.

There’s also the added benefit that, rather than interrupt people with unwanted sales pitches, content marketing offers a non-interruptive approach to customer communication. The ideal is to create a regular stream of valued, trusted content that customers will actively seek out and share.

Pharma’s content-marketing opportunity is to make sure that when a doctor or a patient goes searching for health information — which they are doing more and more — the right content is there waiting for them. When they get exactly what they want, when they want it they’re also happy to pass it on to friends and family. The problem is pharma doesn’t like sharing.

Content marketing principles — valuable content that engages a clearly defined audience – might have been at the heart of pharma’s efforts to help HCPs and patients understand and adopt new treatments for years. Pharma should have a head start in the content marketing race, but it’s firms like Marriot, Old Spice and American Express that are getting noticed for their content marketing efforts, because they love people to share their content

“As a well-oiled content machine that knows how to build relationships, pharma should thrive in this new era,” writes Dr Candice O’Sullivan of Australia’s Wellmark agency on PharmaForum. “Here is an industry well used to the rigours of consistently producing high-quality content — the number one challenge for most content marketers — but finds it virtually impossible to ‘share’.”

O’Sullivan closes by describing Pharma as an industry “too preoccupied by the risks involved to be able to make the most of this opportunity”. Sound familiar?

Peter Houston is former Group Content Director for Advanstar Pharma Science. He is now an independent media consultant and founder of Flipping Pages.

By Susan Haigney.

Pharmaceutical Research and Manufacturers of America (PhRMA) International Vice-President Jay Taylor has expressed the organization’s concerns over the Office of the United States Trade Representative’s (USTR) 2013 Special 301 Report. The Special 301 Report, released in May 2013, is an annual review of the state of intellectual property (IP) rights protection and enforcement in trading partners around the world and reflects the US Administration’s resolve to maintain IP protection worldwide.

Expressing appreciation for USTR’s efforts to ensure IP protection, Taylor expressed dismay that an out-of-cycle review was not granted for India. “The deteriorating protections for patented medicines in India have become increasingly concerning,” Taylor said in a PhRMA blog. “Over the past year, the Government of India has issued several intellectual property decisions that have disproportionately impacted US biopharmaceutical companies and a number of other innovative sectors. The IP regime in India has been structured and applied in ways that prop up local industries to the detriment of US jobs and the worlds patients.”

According to the report, India remains on the Priority Watch List. And with regard to pharmaceuticals and patents, the administration states it has some concerns. “The United States is concerned that the recent decision by India’s Supreme Court with respect to India’s prohibition on patents for certain chemical forms absent a showing of ‘enhanced efficacy’ may have the effect of limiting the patentability of potentially beneficial innovations. Such innovations would include drugs with fewer side effects, decreased toxicity, or improved delivery systems. Moreover, the decision appears to confirm that India’s law creates a special, additional criterion for select technologies, like pharmaceuticals, which could preclude issuance of a patent even if the applicant demonstrates that the invention is new, involves an inventive step, and is capable of industrial application,” the report states.

Taylor also expressed PhRMA’s disappointment that Canada was moved to the Watch List for 2013. “While PhRMA appreciates the fact that USTR raises serious concerns regarding numerous Canadian pharmaceutical IP measures, we are nonetheless disappointed that USTR has changed Canada’s designation despite the fact that no progress has been made on this front. Canadian policies and judicial opinions continue to harm international innovators to the benefit of domestic industries. Canadian regulators have, for example, created a discriminatory right of appeal regime under which Canadian medicine manufacturers challenging the validity of a medicine patent may appeal an adverse decision through an administrative proceeding while innovative international biopharmaceutical companies cannot. We also are concerned that the heightened standard for patentable utility for pharmaceutical patents is inconsistent with Canada’s trade treaty obligations. USTR and the interagency process should push Canada to provide more adequate IP protections.”

The report does express concern regarding rights of appeal in Canada. “With respect to pharmaceuticals, the United States continues to have serious concerns about the availability of rights of appeal in Canada’s administrative process for reviewing regulatory approval of pharmaceutical products and also has serious concerns about the impact of the heightened utility requirements for patents that Canadian courts have been adopting recently.”

Taylor goes on to state support for USTR and the battle for IP protection. “The value of IP protection should not be undermined by discriminatory market access barriers, including discriminatory government pricing and reimbursement policies. We welcome USTR’s recognition of market access barriers faced by US pharmaceutical companies and their efforts to eliminate them in many countries in order to provide for affordable healthcare today and support the innovation that assures improved health care tomorrow.”

The full Special 301 Report, detailing positive and negative findings from countries all over the world, can be found here.

What do you think? Is the US doing enough to protect the IP rights of pharmaceutical companies in today’s international market?

Of the many issues involved with the actual implementation of the 2010 Affordable Care Act, aka, “Obamacare”, few are more intriguing to me than those that personally impact Members of Congress (MOCs).  Here’s a good example of what I’m talking about — Today, on Capitol Hill, MOCs, along with thousands of their personal Congressional staff members, are facing a clear legal mandate that requires them to sign up for Obamacare.

However, according to a recent article in Politico these same Members and their staffs are currently scurrying about Capitol Hill, looking for ways to deftly tip toe around this mandate set to begin January 1, 2014.

How has this happened?  Well, as noted by Politico, in the heat of the 2009/2010 Obamacare debate, Sen. Charles Grassley (R-IA) stated, “It’s necessary and only fair for Congress to live under the rules we pass for everyone else.”  That is, Grassley’s position was that if Congress were to lay this new, revolutionary healthcare law on the American people, then by gosh, those serving in Congress would also have to obtain their healthcare via the same system. And that is exactly what was written into the law.  At the time, many Congressmen, for example, Sen. Sherrod Brown (D-OH), cheered this concept.

But as the reality of the new law has set in, it’s apparent that not every Member of Congress continues to cheer Grassley’s call for medical egalitarianism.  In fact, it seems this issue has caused a bit of internecine warfare on the Hill, pitting those who will be forced to obtain medical service from Obamacare, against those who will not.

In the middle of this squabble is the US Office of Personnel Management that has drawn the unenviable job of ruling on who on the Hill is in, and who’s out. A decision is expected sometime in May.  Currently, the OPM office is in “listening mode” on the issue and Politico reports that many Congressional staffs are in “discussions” with the OPM.

However, as pointed out earlier, the cold, hard truth here is that there really is no wiggle room on the basic issue of coverage.  According to Section 1312(d)(3)(D) of the ACA Act all Members of Congress and their immediate staffs shall utilize Obamacare after January 1, 2014. This care will be obtained either through their home state exchanges, or through the state exchanges of Maryland, Virginia, or DC, depending on where they live in Metro D.C. Seems straight forward enough.

So, what’s causing the uproar on the Hill?  Simple. The 535 MOCs and their thousands of personal Hill staff who, per the law, will be forced to accept Obamacare in about 8 months, will shortly be working side-by-side with thousands of other Capitol Hill staffers who will not have to use Obamacare. Think about that dynamic for a moment.

And who are these “other” Hill people who are exempted from Obamacare?  You may be surprised.

According to Politico, professional staff persons, either working for a standing Congressional committee (such as Appropriations, Ways and Means, etc.) – or working for one of the four Leadership staffs - do not have to sign up for Obamacare.

Additionally, the Capitol Hill administrative staffs (custodians, security, food services, etc.), as well as the entire Executive Branch and its Agencies, also are exempted.

Given that, here’s an intriguing question: does this mean that the federal CMS staffers currently working so hard on the 2014 implementation of Obamacare, are fully exempt from Obamacare? Looks like it. This also suggests that HHS Secretary Kathleen Sebelius, Obamacare’s primary advocate on the Hill, won’t have to sign up for Obamacare, either.

And where is the President on signing up for his signature domestic achievement?  Well, in comparison to his position three years ago when he said “I will sign up!” things have changed.  He is now quoted as saying he “may obtain his healthcare through the program.”

But realistically, as the Head of the Executive Branch, why would he do this?  He is exempt from the law he championed.

In other words, it boils down to this: if you are an elected Member of Congress, or work as part of the personal political staff of such a person, you get Obamacare.  However, if you are basically any other federal worker, you are apparently exempted from the provisions of Obamacare.

And how will all these exempt federal employees and appointees get their healthcare?  They’ll get it through Federal Employee Health Benefits (FEHB), a federal health insurance program that has been in place since 1960. This offering is made up of 250 different private, managed healthcare plans. Members and staff receive 72 to 75 percent coverage of their health costs from the Federal government, with most FEHB beneficiaries paying about 30% out of pocket.  Universally, the FEHB is seen as a very robust healthcare offering, rivaling many of those offered in the private sector. On the Hill, this insurance is viewed as one of the best benefits provided to those folks who work for the federal government, not to mention those elected to Congress.

And that is exactly the cause of the fury on the Hill – Members of Congress and their Hill staffs both in DC and back home must give up their FEHB coverage after January 1, 2014.  And many don’t like that idea.

What’s interesting to contemplate is how this will actually shake out for the 535 Members of Congress and their staffs when they leave FEHB and sign up for Obamacare in the state exchanges.

Let’s take an MOC from California. That state has been way out in front on adopting Obamacare state exchanges. So, theoretically, the California MOC’s in-state staff, living in say, Los Angeles, would be able to get the new Obamacare benefit without too much difficulty.  It’s possible, however, in fact very likely, that the new CA state exchange insurance would not be as robust as the FEHB insurance.  Still, the CA congressional staffers should be able to access the new Obamacare healthcare insurance.

However, for a home state Congressional staffer from one of the 25 states that has decided to just say “no” to Obamacare – Texas, for example – that might not be the case. In fact, for those states, it’s possible the only option for Congressional staff healthcare would be a federally sponsored exchange implemented by HHS.  Controlled and administered by Washington, this offering would likely be a step down from FEHB.

Another big sticking point for the MOCs and staff who are being forced into Obamacare is that while the federal employee reimbursement levels provided under FEHB is about 70%, there is no provision in the new law that states that the new state exchange policies must provide a comparable reimbursement levels (page 2).  In fact, “no reimbursed coverage” is a possibility.  So this diminished level of reimbursement or a complete lack of coverage is something that could turn into a significant personal expense for MOCs and their staffs when they forfeit their FEHB care, no matter what state they are from.

The final point in all of this, and really, this may be the biggest issue of all, is how will Obamacare affect federal retirement benefits?  Prior to the advent of Obamacare, a person with 20 years of service to the federal government, including Members of Congress and their staffs, was entitled to full FEHB “annuitant” health insurance for the rest of their lives.  But FEHB retirement annuities are not part of the state exchanges.  So how will MOCs and staffs get healthcare after 20 years of federal service?  Through their home state exchanges?  Much is unclear on this important question.

On reflection, I think I understand the “fury” on the Hill.  People who have worked together as colleagues addressing the same Capitol Hill problems for years and years, and who have depended on the same health benefits and retirement programs, all of a sudden are being placed on two very different health benefit planes: those who are being forced into the Obamacare state exchanges (if they exist in their states); and those who will continue to cruise along with the very robust FEHB.

And how will Congress likely manage this dichotomy?  Well, I expect Congress will do what Congress does best. Legislate. I look for some very quiet, “corrective” amendments to be quickly offered on Obamacare in 2014, or at the latest 2015.

Although I suspect a lot of Congressional tip toeing to occur around this ‘troublesome’ Obamacare mandate, in the end, we are likely to see aberrations like state exchange programs that specifically provide FEHB-like service to Members and their staffs.  And, at the same time, I wouldn’t be looking for Congress to pass similar benefit upgrades for “everyone else,” as Sen. Grassley put it, for their Obamacare state exchange programs.

Those are my thoughts on the oncoming shift of healthcare services on Capitol Hill.  I would like to hear your thoughts on this situation.

Tom Norton is principal at NHD Smart Communications. He can be reached at tnorton@nhdcomm.com