Ireland's Celtic Tiger: Back on the Hunt

Pharmaceutical Executive, Pharmaceutical Executive-09-01-2014, Volume 0, Issue 0

Leaders from industry, government, and the CRO community examine Ireland's future as a magnet for life science investments, and what the nation must do to remain the leading exporter of finished pharmaceutical products.

Ireland's recovery from its deepest post-war recession is being paced by its steadiest long-term performer —pharmaceuticals—with €29 billion worth of basic pharmaceuticals and preparations produced by the local industry in 2013. That's a remarkable one-third of the total value of products sold in the Irish economy, and almost all of it is earmarked for export, which makes Ireland the global locus for trade in medicines. Earlier this summer, Pharm Exec teamed with a student delegation from St. Joseph's University Haub School of Business to bring together a group of local leaders from government, industry and the CRO community to pose the fundamental question: as competition for the global investment top spot increases, what must Ireland do to keep its light shining bright for big Pharma?

— William Looney

Roundtable Participants

Dr. Brendan Buckley, Chief Medical Officer, ICON

Aiden Corcoran, Chief Executive Officer, Team Horizon Ireland

Tom Kelly, Division Manager for Cleantech, Life Sciences and Electronics, Enterprise Ireland

William Looney, Editorial Director, Pharm Exec (moderator)

Ann McGee, Managing Director, McGee Pharma International

Pat O'Mahony, Chief Executive Officer, Health Products Regulatory Authority

Ciara O'Rourke, Director, Access, Policy and Communications, MSD Ireland

Paul Reid, Managing Director, Pfizer Ireland

George Sillup, Associate Professor and Chair, Pharmaceutical and Healthcare Marketing Program, St. Joseph's University Business School

PE: Ireland is emerging from a severe economic downturn. Recovery has required significant—and painful—adjustments to repair insolvencies in the financial and housing sectors, restore the fiscal balance sheet and revive the country's competitiveness in global markets. How is this transition playing out in the biopharmaceuticals business? As memories of the great recession fades, what actions are necessary to ensure that Ireland remains a key locus for industry investment—is the Celtic Tiger back on the hunt?

Paul Reid, Pfizer: Ireland has a successful record in positioning the country as an attractive place for manufacturing. Eight of the top 10 global companies have manufacturing facilities in Ireland, and we export more medicines than any other country. Irish industrial policy has made the country attractive for a number of reasons, including a tax regime that encourages FDI as well as a youthful, highly educated, English-speaking workforce. Compared to other OECD countries, Ireland has among the highest proportion of students with third -level academic credentials—that's important to a knowledge industry like pharma. The Industrial Development Agency (IDA) also does a very effective job enhancing Ireland's attractiveness to foreign investors, not only in our specific sector but in other businesses that depend on high technology.

Nevertheless, the industry is changing and Ireland must keep pace. There is a global shift underway from small molecule manufacturing to a more specialized focus on biologics. Pfizer is contributing through a $30 million upgrade at our Ringaskiddy plant to ensure some of the more complex small molecules coming from our pipeline can be manufactured here. An additional investment of $100 million has been secured for biologics at our Grange Castle facility. We need to be attractively positioned in this space to secure more investment and expand opportunities for the local workforce. Competition is a given: for example, Singapore is another small island market vying to attract pharmaceutical investment that performs equally well against Ireland in terms of both tax and education. Education is no longer a unique differentiator for us; we have to keep looking for ways where we can add value.

One area where improvement is required is Ireland's status as a site for clinical trials, where Ireland is lagging along with the rest of Europe. This is significant because of the R&D spin offs from a robust trials platform. Our high cost base, forged during the boom years of the Celtic Tiger and led by an uncompetitive labor market, accounts for much of this lag. What I would like to see is a comprehensive plan, working closely with academia and the private sector, to address our long-term competitiveness in the life sciences, with the overall aim of attracting more international R&D to Ireland. Attaining this goal demands we leverage our strong investigational research capabilities through more joint collaborations like the three-year pact Pfizer recently agreed with Science Foundation Ireland to investigate promising drug targets with local university researchers. Last, but not least, the government has to be willing to "walk the talk" and actually fund the innovations that result from these partnerships, by allowing Irish patients greater access to new medicines.

Ann McGee, McGee Pharma International: One additional attribute of Ireland is the commitment to compliance and quality. The Health Products Regulatory Authority (HPRA) and industry work well together in advancing this agenda. Investing upfront to ensure quality and compliance helps to counter concerns about Ireland's cost base because experience shows that failure to do this will actually increase costs down the line. China and India can claim lower manufacturing costs but there is also evidence of quality problems in their supply chain that have the potential to result in harm to patients. Ireland's track record is spotless in this regard—it's a differentiator that we must leverage in seeking investors.

Ciara O'Rourke, MSD Ireland: We have to dispel the myth that investing in Ireland is only about our low corporate tax rate. Ireland's best and strongest argument is that all the factors that contribute to a positive investment reputation are here, in one place: a solid physical infrastructure; quality; compliance; an educated, English-speaking workforce; and privileged trade access to the entire European market. I'd also point to the support from government, through the IDA, in subsidizing investments in worker training and other activities designed to raise the bar on performance.

Aiden Corcoran, Team Horizon Ireland: My background is engineering, and from that perspective Ireland is evolving in the right direction. I began my career in the 1990s, when all of my engineering school colleagues were moving into the semi-conductor field and taking jobs—as I did—with firms like Hewlett-Packard. Today, our engineering graduates from the millennial generation are focusing on pharmaceuticals and medical devices. That is important because one thing engineers do well is improve the processes and adapting the technologies that turn the conceptual aspects of innovation into products that actually work. It's an essential service function that Ireland needs if it is to stimulate more homegrown innovation.

Dr. Brendan Buckley, ICON: With specific reference to the local climate for clinical trials, the government has provided seed funding for early phase translational clinical research designed to move ideas generated in the academic laboratory setting forward to the trial stage, in cooperation with industry. The challenge is bringing this work into the crucial Phase II (b) stage, when costs start to mount. Because Ireland is a small country, finding the right candidates in sufficient numbers for trials can be time-consuming, especially with the current emphasis on "salami slicing" big diseases into targeted treatments geared to sub-sets of patients with specific diagnostic markers.

We also face a decline in the number of eligible clinician investigators due to fiscal belt-tightening during the financial meltdown. A lot of senior consultant posts in the hospital sector are sitting empty because salaries are now well below the norm internationally. Persuading talent that is better compensated elsewhere to come back to Ireland, while facing the added burden of very high housing costs, is a tough task. It follows that those who remain are increasingly pressed for time and don't want the added burden of participating in trials. This is especially true for physicians grappling with the tsunami of chronic care ailments like diabetes, accentuated by an overstressed and disorganized national health service.

Oncology is the one exception to this situation, due to a novel cooperative arrangement with the US National Cancer Institute (NCI), which led to the creation of a partnership called the Irish Clinical Oncology Research Group. The Group has effectively organized the oncology profession to take on the task of enrolling virtually every cancer patient into a clinical trial, which has kept the numbers up while also providing financial support. I can also say the regulatory process for registering trials is highly efficient: you can apply in parallel for an IRB and HPRA approval and a go-ahead usually occurs within six weeks, if the protocol is good. In other words, the regulatory system is not skewed to catch and fail you, as is often assumed.

Pat O'Mahony, Health Products Regulatory Authority: I agree that Ireland is a place where many positive elements come together to keep us competitive. The challenge for any regulator today is to understand how industry is becoming more complex and sophisticated. Very often the regulator is behind the curve of what is actually happening in the field—we are playing catch up. The HPRA deals with the largest and most globally sophisticated companies in this industry. We give these companies huge allotments of our time when they come to share their investment plans with us. We dutifully inspect and approve their new facilities, only to have the US FDA come and repeat the same process a month later. To us, this is a duplicative—and unnecessary—step. We are working hard with our US colleagues to convince them of that.

On clinical trials, I believe this has to be considered in a global context. Ireland's situation is influenced by the EU regulatory regime as well as trends in the US and in Asia. On a comparative basis, the truth is that trials are moving out of Europe. This is taking place for a number of reasons, perhaps one of which is the impact of the recently revised EU clinical trials Directive, which places additional obligations on sponsors. Ireland's own regulatory framework for trials is among the easiest to navigate in the region. The real problem is how our small and relatively homogenous population makes it hard to recruit the 100 or more people in small niche groups demanded of trials for increasingly rare indications. There is a solution in sight: I would like to see Ireland raise its profile as a preferred site in multi-centered, multinational trials, where we can furnish five to 10 or 20 patients for the protocol. That is the best position for us.

From a personal perspective, a stress point for Ireland is the colossal pressure our public health service has been under during the past three years of recession. If Ireland is to make good on its pledge to support medicines innovation, more coordination is required between those who run the health service and those who manage biopharmaceutical industrial policy. Right now, both are often at odds: while the IDA works to bring drug companies here to invest, the fruits of that investment—in the form of new innovative drugs—are often denied to Irish patients. We need to think seriously about new ways to ensure greater access for the best new innovations. If the national health budget cannot accommodate such spending right now we should still do it, because not doing it influences the way we are viewed as a locale for FDI.

I have taken this integrative stance in restructuring the HPRA's own work flow, which used to be stove-piped into separate units for human medicines, medical devices, veterinary drugs, etc. Three years ago, I removed the internal barriers and created a single point of entry for all human health products, with separate tracks for pre-market approval and post-market approval, the latter focused on monitoring pharmacovigilance, regardless of product. The HPRA is unique in taking this approach; only Japan is following our lead. The FDA—so far—is not.

Tom Kelly, Enterprise Ireland: Enterprise Ireland has a specific remit to support indigenous Irish industries rather than the multinationals, so the comments on supporting local R&D are quite relevant to our work. Ireland has not wavered in its priority to build the science base, despite the severe economic downturn. Public investment in science has held up well; the numbers show we are now close to the EU norm in the percentage of GDP we devote to research. And we made a commitment more than 15 years ago that a good portion of this investment would center on biotechnology and ICT. A network of technology centers throughout the country, jointly funded by Enterprise Ireland and the IDA, have had a useful spin-off effect on the manufacturing climate in biopharmaceuticals, which carries residual benefit for the multinational investor. We are also taking advantage of the extensive assistance available at the European level through the EU's Horizon 2020 program.

PE: The group has identified a number of issues that appear to differentiate Ireland as a positive location for biopharmaceutical investment along with a few challenges that require the redoubled attention of the country's policy and business leadership. Are you confident that the attention and the resources are sufficient to meet these challenges? One of our student observers noted a disturbing parallel between Ireland and Puerto Rico, which has lost most of its manufacturing base in pharmaceuticals and has no realistic prospect of competing on innovative R&D. Do you share that perception?

Corcoran: I don't think there is any parallel here with the situation in Puerto Rico. The human capital base in Ireland is far more advanced and we have the advantage of being a part of the world's largest single market for medicines here in Europe. Being a member of the EU forces us to keep up our "A" game.

O'Rourke: One of Ireland's hidden assets is our ability on the corporate side to sell Ireland internally to decision-makers at HQ. At MSD, we have a reputation as a place to bring a problem and then to work out a solution. We get it done and this example then filters back to other sites. This internal reaffirmation of Ireland's value may be little noticed, but it is critical to maintaining our global credentials as a place to invest. Merck, like other multinationals, recently went through a network consolidation that resulted in a decision to close two sites in Ireland. But what we retained at our three remaining sites are capabilities that represent the future of the industry—in vaccines, oncology and biologics. This is precisely the avenue we must take because Ireland won't thrive if it can only compete on cost. It's the excellence in innovative strategies and execution that counts.

One difficult area we have faced is explaining to management why products manufactured here are not always easily available to patients under our national health service. Reimbursement has become a significant challenge in recent years. The industry is committed to finding ways to ensure patients get access to innovative medicines at a fair price. For example, the industry has taken very significant price reductions on off-patent medicines to allow for some leeway in paying for true innovation—giving patients access to new medicines at a fair price, following an evidence-based health technology assessment. Demonstrating that innovation is actually being supported through favorable actions on reimbursement is a powerful message to those who make investment decisions at HQ.

Reid: We also are recognized internally as an affiliate that gets things done. One of Pfizer's global business imperatives is to earn more respect from society. Because of the fellowship within the pharma space in Ireland, we were able to develop an initiative called Healthy Towns, where we select a municipality every year and then develop a joint program with the local council and other stakeholders to achieve certain metrics in promotion of a healthier lifestyle. It has nothing to do with medicines and from it we have gained an enormous amount of good will.

O'Mahony: Something I have noticed is the high level of collaboration between the drug multinationals with operations in Ireland. This is a very transparent group; they share information and help one another. It helps explain why Ireland is not in similar circumstances to Puerto Rico.

McGee: As a nation and a people, we are very open. Everyone in the industry is constantly benchmarking their performance against their peers and as a consultant I find there are few obstacles to sharing the insights gained from that.

Corcoran: My company currently has five staff advising German companies how to manufacture complex biologics. If you can go to a world-class exporter like Germany and tell them how to manufacture, then I think you can be confident your base is covered.

PE: One student observer has noted the proliferation of APIs from India and China in world pharma trade. Some facilities in these two countries lack the sophisticated quality controls in Ireland and in the US. What is Ireland doing to preserve safety and integrity of the supply chain on which you base that reputation for quality all of you cited in the opening remarks?

McGee: In July 2013, the European Medicines Agency (EMA) approved a Falsified Medicines Directive that imposes very rigorous standards on manufacturers to guard the quality of APIs. This is a good start, even though a few companies are still relying on some sites in China where the standards for APIs might not be world class. The Directive requires auditing of these foreign sites down to the level of the composition of the material itself. This is a more detailed requirement than a simple, locally certified regulatory inspection. It also puts the onus on the company importing the API to take responsibility for use of the compound material: if the material is unsafe, then you own the problem and are expected to fix it. So what we have is a combination of strong regulation and the self-responsibility of industry to avoid the financial consequences of a supply chain failure.

O'Mahony: There are enormous pressures on the global supply chain today. Regulators can be inspecting a plant somewhere in the Far East; the day they leave, raw materials come in from five satellite facilities no one even knew about. The complexity of the situation defines our responsibilities as regulator. I tell my staff that because we don't make medicines, we cannot make them safe. That responsibility ultimately lies with industry. Our job is to work in partnership with companies to exercise oversight, always on behalf of the patient. What I worry about as a regulator is how the market can focus attention on short-term financial incentives, which in some quarters may lead to the impulse to cut corners in defending the supply chain. Fighting this impulse demands real collaboration and joined-up thinking.

That has to start with us. One instrument is the International Coalition of Medicines Regulatory Authorities (ICMRA), a group of the heads of about 20 agencies—including the FDA; EMA; the EU Commission; five national European agencies, including ourselves; Japan's MHLW; Health Canada; and the drug approval bodies from Mexico, Brazil, China, Switzerland, Australia, New Zealand, Singapore, Nigeria and South Africa. ICMRA is a forum to build consensus among agencies on how to promote transparency, remove unnecessary barriers or duplication of effort, and safeguard the integrity and quality of medicines moving in international commerce. HPRA hosted one of the first meetings of the group after its launch six years ago.

At our last meeting in December, a paper I co-presented with my colleague at Health Canada resulted in the creation of a new steering committee on a two-year appointment cycle, a plan to expand membership based on compliance with the standards we set as a group, and a series of special projects like creating a joint system for managing inspections. Right now, there are no formal mechanisms in place to do that; the process is entirely ad hoc. All of us realize that overall the resources we devote to inspections is way below par given the globalization of commerce in medicines. Hopefully, a more joined-up structure will allow for greater efficiencies in deploying those resources.

Despite our best efforts, I do worry about interruptions in the supply chain that carry adverse consequences for public health. Maximum vigilance is required. Consider if you are a foreign generics maker who grabs a good deal on APIs on the spot market—will you take it and, if so, will you demand and carefully review any of the certifications that are supposed to be supplied with them? We can't predict what the answer to this question will be, but failure to check could be catastrophic.

PE: Is ICMRA intended to replace the International Conference on Harmonization (ICH), a similar group where industry has a seat at the table?

O'Mahony: No. ICMRA is a group of agency heads. ICMRA is strategic, while ICH is more staff driven. The aim is to use ICMRA to provide some gravitas, scope and direction to ICH and other collaborative bodies.

McGee: Regulatory harmonization is a misnomer the way it is done presently. Even when you declare harmonization, there are huge differences in interpretation by agencies across the world, especially here in the 28 EU countries. In a practical sense, transposing Directives at the member state level leaves industry with 28 different interpretations of the same rule. There is a dire need to turn these Directives into Regulations, which by EU law have to be implemented verbatim.

O'Mahony: This is clearly the trend and overall it is a good move for industry. Governments may spend four years haggling over the text, but once approved as a regulation you have clarity.

PE: How vital is a strong industrial policy presence to Ireland's future competitiveness in biopharmaceuticals? Is it possible for government to encourage more indigenous growth in an era where trade and investment flows are dominated by the largest multinational corporations?

Kelly: It depends on the depth, quality and relevance of the strategy you pursue. Initially, Enterprise Ireland followed a course of building on the base created by the global pharmaceutical firms, where we encouraged the growth of suppliers, contractors and service companies for these big investors. Today, the objective is to build local companies that stand out in a particular niche and are ready to compete in the global market. It is founded on the realization that, with only 6.5 million people, Ireland is too small to survive without the ability to export. In fact, where you export is an issue of particular importance to us: many local Irish companies are over reliant on the UK, so we want to help them advance sales in larger markets like Germany. The success of that country's mid-tier Mittelstand companies in global export trade is a guiding example for us.

The other element of our strategy is providing financial incentives to help local entrepreneurs launch start-up businesses in life sciences. We make seed capital investments in about 100 life sciences companies each year, which provides entrepreneurs with a leg to stand on until they can pitch funds from private venture capitalists. There is also the mentoring we do in business facilitation practices along with a commitment to help launch private venture capital arrangements in the life sciences. A good example is our BioInnovate program with the National University of Ireland in Galway. It is modeled on the Stanford University program in the US that brings entrepreneurs close to the hospital system to identify issues that need resolving and to create new business opportunities from that.

Buckley: The food industry, which has benefited from significant government support, is a virtuous cousin to our stake in biopharmaceuticals. It is not just about raising more cows in fields of green. The food industry is very biotech in orientation and Irish enterprise is doing some novel work in areas like fermentation and additives that apply directly to the process of making drugs. Another synergy is with local makers of high-tech stainless steel machinery used in batch production of complex biologics, where precise temperature and sterile fabrication is required. This is an internationally competitive group of companies that began in Cork doing welding work on milk tanks.

PE: Government investment in the development of innovative industries is clearly a positive, but is this sufficiently bolstered by policies that actually reward entrepreneurial activity and help the investor manage risk? It appears that sector-based financial aid and the larger fiscal balance sheet are working at cross-purposes in Ireland.

Reid: There is a particular imbalance affecting our sector that worries me—between prioritizing investments in health and the budget austerity imperative to cut and cut again. This is a debate not about medicines but about healthcare spending in general. In my view, we have cut the health budget enough; now we must reinvest and put much more momentum behind programs like the Healthy Ireland campaign. A successful outreach here carries enormous consequences for Ireland's future, as a country and as a place to do business. Pure and simple, a less healthy population means lower growth.

O'Rourke: Reform has been on the political agenda for years. The system itself is changing so rapidly that it is worth considering whether there is any point to a radical overhaul. Perhaps the focus should be on feasible fixes that could be implemented right now. I am thinking of actions like the patient pathway initiative, engaging more clinicians in the process of setting clear protocols and standards to reduce patient waiting times. Giving clinicians the lead in fighting cost escalations is a novel idea that hasn't been tried here.

O'Mahony: Ireland is no different from other OECD countries—our healthcare is going to cost more. Our citizens are older and living longer, and many new interventions now exist to treat them. It is politically impossible to deny these technologies to a voting public. Government cannot freeze things in place—the person who is going to live to be 150 has already been born. We also have to stay within the bounds of our culture and preferences. Ireland long ago committed to providing every resident, regardless of income, with access to good, basic medical care. That is not going to change.

PE: Talking about finding more efficient ways to defray the cost of medicines, how is Ireland managing the development and registration of biosimilar drugs?

Buckley: There are numerous biosimilars in development in Ireland, but the prospect of obtaining significant saving from these new products is probably much less than what could be achieved with generic versions of small molecule drugs. The best guess is a 20% reduction against the market price of an original compound. In addition, there are expectations from payers that biosimilars will be swiftly self-adopted by physicians and patients, avoiding costly investments in safety and compliance studies. This is why the big pharma players are pitching biosimilars around a service-oriented platform that helps maximize the savings, provides assurances on safety, and promotes a patient-friendly adherence. This is another signal of how we are entering an era where companies will look not at the unit cost of a single product, but on building a framework of value-added services around the product, in collaboration with other stakeholders.

Reid: There is a valid market rationale for biosimilars. What is required for the segment to grow is a sustained, high-profile commitment by industry and regulators on quality and patient safety. Ireland has pledged that biosimilars will not be interchangeable for prescribing. It is nonetheless most important to have a clear delineation between INN and brand name prescribing, to ensure the proper management of pharmacovigilance regulations at the European level.

O'Mahony: Getting the regulatory structure for biosimilars right and on track is vital—because if we don't, it may turn out to be the next big safety issue in medicines. And it may become apparent only over the passage of time —in 10 to 15 years.

Buckley: Likewise, there is concern that the trials required to get a biosimilar on the market are far too small to establish the safety signals that some scientists and regulators believe are necessary to protect patients. Given this situation, only pharmacovigilance evidence rendered over time can determine this conclusively. But that may not be possible either, if the pharmacovigilance system is unable to distinguish between the originator drug and the biosimilar. The concern is the drug has to be tracked; and to do that you must know what the patients actually took.

PE: What about the status of the framework agreement negotiated by the government on pricing and reimbursement for drugs in the National Health Service? I understand this three year pact is at the mid-way point, and is now undergoing an interim review on how well it is working.

O'Rourke: Pricing and supply of medicines has been determined following joint negotiations between industry and government. The current three-year arrangement finalized in October 2012 is projected to deliver €400 million in savings on the drugs bill. That figure has to be put in a wider context: since 2007, the industry has taken on no less than nine price cuts; being asked to deliver concessions to the government is now a routine.

Our position as a R&D-based industry has been very consistent, offering price cuts on older, established medicines that are either patent-free or coming off patent, in return for pricing flexibility for new innovative products. The recent introduction of generic substitution and international reference pricing adversely affects pricing and these measures are having a substantial impact on employment—job cuts have been made, with fewer new positions created. Some smaller drug manufacturers have moved their base out of Ireland, retaining only a sales presence while other, more valuable functions relocate to the UK.

On a strategic level, the situation demands we do more to build our relationship with the Department of Health to create the kind of partnership we now have with the Department of Enterprise and Employment. The latter accepts our credo that medicines are an investment rather than a cost, because of the impact innovative medicines have on adjacent savings in acute care and other downstream operations. The challenge is working with the Department of Health to help them understand that medicines are not a commodity, a procurement line entry no different than bed linen, with price as the sole criteria for selection. The dialogue needs to change.

Reid: Industry is delivering what we committed to: since 2006, just under €1 billion in savings has been delivered to the government through price concessions. Generic substitution and reference pricing have really brought down the price of all off-patent products. And these two measures exist beyond the scope of the 2012 bilateral agreement due to their enactment through the Medicines Bill legislation. For in-patent products, which is the critical touch point for our innovative capabilities, prices in Ireland are now fully in line with the average in the nine reference countries cited in the legislation; there is no price premium.

One thing we do want to discuss with the government is the specific approach to end of life treatments, some of which are very expensive and will likely not hold up to scrutiny for cost effectiveness under standard health technology assessment (HTA) criteria. We have to ask if the right process is in place to meet the needs of the payer and the producer while making sure we don't restrict access to these novel medicines to patients. A constructive dialogue on this topic is important because over the next decade the world —not just Ireland—will see many new high cost interventions coming on the market that carry unique therapeutic characteristics, promising to save many lives. So there is a lot of work to be done here.

PE: Is the HTA procedure being used appropriately in rendering access and reimbursement decisions here in Ireland?

Reid: Industry supports the use of this tool, but what remains unclear is whether the HTA determination is the only factor on the table. If you are a drug company that has just spent close to €1 billion on a new medicine, you would not want an HTA analysis to be the sole decision point on pricing and funding. Other aspects can be of equal or greater importance.

O'Rourke: The industry works well with the National Center for Pharmacoeconomics, which is responsible for cost effectiveness evaluations. The process is thorough, transparent and collaborative. However, many new technologies such as oncology medicines are not going to fit within the narrow methodological approach to cost effectiveness, and in many cases the final decision to reimburse is delayed or put aside. Data we have indicates that the delay from judgment to obtaining full permission to reimburse can take 18 months, on average. That's a long time for a cancer patient and in some cases it will be too late.

Buckley: One key difficulty is that decisions on access and reimbursement are not based on science or economics—in the end, the process is a political judgment. And when the media gets involved, it is easy to turn this into a cinematic exercise laden with cheap shots. The rhetoric is "I could get the drug in Spain, but not here." In this coarsened debate, industry ends up a loser, but the larger irony is that society loses too, because the focus is only about money, not value. It is the polar opposite of a rational discussion to facilitate the best use of public resources.

PE: Can you identify the one priority that Ireland must execute over the next three years to raise its game as a preferred global location for biopharmaceutical research, manufacturing and investment?

O'Mahony: The HPRA has launched a dialogue on the future of regulatory science to increase our ability to keep pace with transformations in science. All key stakeholders are involved, including academic medicine leaders and R&D chiefs of the multinationals here in Ireland. I expect in 12 months we will have in place a new model on research training that ensures HPRA is fit for purpose in fulfilling our public trust to clinicians and patients.

Tax Facts

Reid: The one priority has to be a stepped-up commitment to public-private participation and partnership, all geared to obtaining the best outcomes for the Irish patient. Collaboration may seem a cliché, but we need more of it in Ireland.

Buckley: Policymakers must oversee a normalization of the staffing levels, remuneration and overall attractiveness of academic medicine in Ireland, which has been impaired by recession and neglect. Without this, Ireland won't reach its potential in R&D, nor will we succeed in encouraging clinical trial work to return to this country.

Corcoran: Ireland must do more to support its youth, particularly in encouraging the younger generation to take up disciplines in engineering science, mathematics and data analytics that are becoming more important in driving growth in the life sciences, as well as other business sectors. We need to expand the diversity and breadth of our employment base as a driver of global competitive advantage.

McGee: Raising our game on quality and compliance is the vital connection to keeping the Irish medicines market internationally competitive. This goal cannot be sacrificed to the short-term fixation on controlling health costs. Developing innovative medicines is probably the most value-adding activity any business can undertake.

O'Rourke: Our priority must be to find better ways to represent ourselves as a true stakeholder with the decision-makers in health. We must strengthen our working contacts with the Department of Health in addition to those agencies we interact with as an assigned constituency. Working together we can achieve much more.

Kelly: Mine is more of a personal, rather than a professional, response. There is a crisis in Ireland in the way we fail to promote the potential of youth, particularly young men, through rigidities and resource constraints in our primary education system. There is a large gap between girls and boys in the numbers who advance to third level education, and the job opportunities that extend from that. I worry that an entire generation is effectively being left out of the chance for a better life, precisely when that life is just beginning. Initiatives to address the gender gap in higher education would materially improve the economic prospects of this country.

William Looney is Pharmaceutical Executive's Editor-in-Chief. He can be reached at wlooney@advanstar.com.