Interview with Paul Flapper, General Manager, Shire International Licensing BV Netherlands

Shire has many offices in America, Europe, as well as in Singapore, in Japan and in Australia. The group has a vast global network and a strong presence in these four continents. What is the strategic role that Shire Netherlands plays and how does this role fit into the group’s global strategy?

One of Shire’s missions is to enable people with life altering conditions to have better lives. European markets are very different from one another and Shire sees the importance and relevance of having a local workforce and the qualified people in the relevant markets with a specific knowledge of the market, in order to ensure that the specific needs of physicians and patients in each market can be well addressed. This way, the group makes sure that the time frame for product development is as short as possible. The reimbursement schemes in the Netherlands are today one of the main issues that the industry and the country in general are facing. For instance, it may happen that companies develop, through very hard work, a molecule that reaches authorization but is not (or with very much delay) ultimately accessible to the patients, for cost-related reasons. This situation is deplorable.
I can give you an excellent example. In 2007, we obtained marketing approval for our treatment against Hunter syndrome – a life threatening condition caused by the absence of an enzyme leading to a deterioration of the physical state of the patient. The damages occurred are irreversible. The policy rule for orphan drugs in the Netherlands was only passed in 2006. Thanks to Shire’s knowledge of the local market, we were able to bring Elaprase to the patients – a product which treats carriers of Hunter syndrome – about half a year earlier than the original time line and under normal circumstances, which means we waited until the procedure of reimbursement was completed. When I joined Shire in 2006, I had the chance to quickly learn about this policy rule and the possibilities that the Dutch government had created for this disease. Officials are aware that orphan diseases are an area where the bureaucracy of the reimbursement procedure should not stand between physicians treating patients with a drug that has proved efficacy and safety. Therefore, a form of retrospective reimbursement is used for these treatments. In the Netherlands, as soon as a dossier for reimbursement has been submitted, the treatment of the patient can start. This situation is unique to orphan drugs because they imply a lot of efforts in terms of research and are destined to a low number of patients, especially those affected by Hunter syndrome.

Since the availability in 2006 of the enzyme Elaprase, for the first time Hunter syndrome patients have access to a treatment in the Netherlands. To what extent has this evolution changed your activities at Shire Netherlands?

Knowing exactly what you can do rather than looking for what you cannot do is a key concept in my activities at Shire. In my opinion, nothing is impossible until it has proven to be a dead end. Elaprase was part of the first early access programme that ran in that policy rule in the Netherlands. Elaprase was actually the second product that went through the procedures of product evaluation for reimbursement. Finally having access to a treatment against Hunter syndrome was a tremendous achievement for patients and families that were waiting for the drug for many years. Families have followed the progress of the clinical trials for the drug.
I used to be marketing director for my previous company where I was responsible for the largest product in the Netherlands. I find a place for my personal feelings in marketing activities. Being a father myself, I know how important it is that a drug is made available to the patients, no matter the cost. I happen to work until three o’clock at night behind my computer in my home office, to make sure that early access programs are written to be approved and to be used.

The Netherlands, already oriented towards cost-containment policies in the pharmaceutical industry, now finds itself in an environment of fiscal austerity. Deep budget cuts, particularly in the health sector, are expected. What are the implications for Shire? How has this affected your sales & marketing Strategy?

I will never lead my efforts or have my efforts lead by costs or by gains. Naturally, if my company generates operating losses all the time, it is impossible to survive. The main issue that I see when dealing with cost is too high of a rationality concept whereas there is much more involved in people’s health. Cost is no longer an issue as long as you can show how high the value of the drug is and its empowering ability to save peoples’ lives. What is the value of life? We cannot answer that question. In the Netherlands, the small size of the country offers us the opportunity to have a price reference system for many of our products, as opposed to England, France, Germany, and Belgium. Therefore Dutch procedures are very simple, especially for orphan drugs with very clear policy rules and criteria. Thank goodness there are there; the funding is no longer temporary like it was in the past. These rules exist in the Netherlands because there is an increasing awareness that patients of orphan diseases should no longer be without therapy despite the fact that the disease they carry is very rare. The industry no longer focuses only on big market diseases, as it has done for years. This new consciousness has brought more light on the horizon for a category of patients.
It is amazing how Shire brought four products to the market in the four years that I have worked for Shire. I do not know any other company that can claim a product launch in such important and difficult therapy area every year. This could be only my own perception, but I feel that slowly the entrepreneurial driving force has faded away from many companies because they were overwhelmed with certain responsibilities. When fear comes in, people do not dare to take risks. Shire is successful because the patient leads our work. Shire’s portion of revenue reinvested in research or allocated for developmental programs is very high. This strategy ensures our success in the long-run.
Shire continually develops new molecules and runs clinical trial programs largely within timeline, far ahead of our original schedules, as is the case with our work for Hereditary Angioedema (HAE). Many operations seem to be impossible to achieve at the base, however from the moment you give them time, thinking and energy, you can change that perception. It is also a matter of prioritizing work. I re-examine priorities everyday to ensure that what was important yesterday is still important today. My agenda needs to be constantly lined up with the market and what is happening there. The results are simple: whereas most pharmaceutical companies have supply issues, we over-deliver rather than under deliver.

Leonard Terp, general manager of the Specialty Pharma Business Unit in Germany, told Focus Reports last year: “The pharmaceutical industry today is struggling with its image. For many, its reputation is no better than that of the weapons industry or the tobacco industry. This misperception of the industry can be summed up in one sentence: the pharmaceutical industry is making money from people’s suffering.” How can the Dutch pharmaceutical industry better brand itself and how does Shire pharma Netherlands contribute to a positive image of the industry?

It is indeed unthinkable that we keep allowing people to disrespect the tremendous work needed to bring a product to the market – from clinical research, to the work of physicians, and the efforts of the governments in order to address healthcare issues. It is not the pharmaceutical industry that is creating diseases in order to make their living. Diseases exist in our community, it is a fact; there are illnesses that had no solution in the past. Neglecting what is affecting certain patient categories is a strong mark of disrespect towards the patients and the problems they are facing. An often heard complaint with rare diseases is, “it is my tax money used to cure these people”. Nonetheless, it is worth it to take the chance to cure them thanks to the therapies that become more and more available; these are little miracles that can be created through the joint cooperation of patients, physicians, and industry.
Unfortunately, when I am interviewed by a newspaper, in most cases, the journalists are not interested in the good news. On the contrary, they are interested in controversial news. For instance, when Organon was forced to stop their gold injection therapies, a front page newspaper article appeared entitled, “Patients suffer from the fact that Organon can no longer supply.” My previous company had a similar gold injection based therapy which was yet not available in the Netherlands because it was not cost efficient. Indeed, the therapy addressed only about 17 patients in the Netherlands. We decided, not for commercial reasons, but for patient benefit reasons, to introduce this therapy in the Netherlands and allocate a specific budget for it. This initiative also appeared in the newspaper but was barely visible on page six or seven. In such a situation, how can we brand ourselves? I sincerely do my work following the interest of the patients first. When I do well, and keep that as my main focus, my business will be fine.

Looking forward, how would you like to develop the image of the industry? How would you like to see the pharmaceutical environment in general Shire specifically fitting into it?

My priorities are to make Firazyr, a treatment against HAE, available in the Netherlands. Block products have been used for 30 years to treat HAE attacks. Since the 2006 policy rules for orphan drugs in the Netherlands, and our products being considered as orphan drug treatment, Shire needed to apply for orphan drugs reimbursement for Firazyr. One of the conditions to have a successful uptake of the product on the policy rule is to prove that the product has an added value. There are no discussions about the fact that Shire’s products are at least equally effective and safe. Moreover, Firazyr is much more convenient, as HAE attacks can happen at any moment and the product can be carried by the patient. Whereas the block products need access to the veins and therefore requires equipment, Firazyr requires only the use of a syringe; anyone can put that syringe in your stomach. By fear of not being able to use their treatment, most of the patients do not go on holidays, stick to their environment, and isolate themselves. Although a lot of testimonials have shown the added value of Firazyr, at the moment, the Dutch government has not allowed Firazyr to be fully up taken on the policy rule, therefore it is not in hospitals’ budgets. However we know there are many hospitals with budgetary problems and will only prescribe in the highest need.
I understand that I need to follow the guideline of the policy rule, but on the other hand, I see the substantial unmet needs of patients and physicians. Making sure that we overcome these issues is among my top priorities. The difference that I want to make is to bring a therapy to the patients and the physicians: this is my most meaningful objective.

How are you working on a government level to change that regulatory system so that products are more accessible and reimbursed? What kind of advocacy are you doing for orphan drugs here?

I started Shire Netherlands as a sole person and therefore I had to make choices as I was wearing all hats. Slowly, my tasks became more managerial due to Shire Netherlands’s growing product portfolio and to an increasing number of employees. I attended Biofarmind and Nefarma meetings, but the associations were more specifically addressing the needs of our business capabilities. Top Institute Pharma is a very good initiative started under the previous government. When different organizations, industry, patients associations, and government, cooperate on the same issues, there is spin off of the efforts made and those efforts are innovative. In 2006, one of the projects I was involved in was a TI Pharma initiative for orphan drugs. Whereas our product was at first not accredited, it ultimately obtained later phase accreditation. Shire can now show its excellence in execution, given the two A-nominations we received, the highest nomination for a project. TI Pharma enables us to combine what is important for the future, spend our time very effectively, and make sure that important things from an industrial point of view are being shared amongst the parties.
Over the past four years, I have met many stakeholders in this industry through meetings and workshops; I spend some time networking in that kind of environment. The influential people then advise us to speak to defined people in the government, however I do not consider it lobbying.

What would you like to say as a final message on behalf of Shire to this community, the government, the physicians and the industry, as well as to the international readers of Pharmaceutical Executive?

We have made tremendous progress in certain disease areas. In order to leverage the progress and the success that we have already made so far in certain diseases areas such as orphan drugs, we need to continuously and increasingly work together, understand shared issues and make sure that each party from its position, with its own responsibility, fights for one common objective: ensuring progress and bringing healthcare to the population.

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