The mothership

"If I want to speak to Europe, who do I call?" That rather cynical remark was attributed to Henry Kissinger around 30 years ago, in the relatively fledgling days of the European Union (EU). He was attempting to question the concept of a coordinated, unified Europe. Arguably the question posed by Mr Kissinger has now been answered; the newly ratified Lisbon Treaty having created a role of President of the Council of the European Union.

Whether Mr Van Rompuy would be willing to take the call from Mr Kissinger or the current incarnation of US Secretary of State, Hilary Clinton, is a moot point. However, no-one would any longer deny the importance or relevance of the EU. Many sectors have had to answer the Kissinger conundrum for a long time – as the EU has grown in credibility, it has cast a greater influence on the various business environments. This in turn demanded a method for regular engagement with policy makers, to make representations to ensure that wider potential impacts were communicated and understood. Pharma has had to work within the Kissinger conundrum for years, with the same challenges. Historically there was no individual or department with responsibility for the pharma industry; it was spread across several commission functions.

There are a number of legitimate reasons for this, with much of them stemming from the multifaceted nature of the relationship between the EU and pharma. It also reflects the division of responsibilities within the EU, where healthcare expenditure remains the responsibility of individual member states, meaning they have the responsibility of determining what percentage of GDP is allocated to healthcare, what levels of pricing and reimbursement will apply to products. Therefore the relationship with the EU has traditionally been an industrial/business relationship.

Even excluding the national budgetary responsibility, this had a substantial logic; the research-based pharmaceutical industry is a major contributor to the European economy, delivering a trade surplus in excess of €50 billion. It is also a major employer and job creator, engaging almost 650,000 individuals in highly-skilled jobs with many more indirectly employed upstream and downstream. This value was reflected in the industry's principal relationship with the EU, with the main responsibility falling to the Enterprise Directorate general, rather than Health and Consumer Directorate. Most of the recent legislation impacting the industry – most noticeably the so-called 'pharmaceutical package' covering counterfeiting, pharmacovigilance and information to patients – stemmed from the desk of Günter Verheugen, the commissioner for enterprise and industry. Notably, the package also contained a Communication on the future of the pharmaceutical sector.

That economic contribution aside, public health and pharmaceuticals are inseparable, and despite member states having ultimate responsibility for budgets and expenditure, the EU is taking an increasingly active role in setting public health priorities; on pandemic, on cancer, on HIV/AIDS. This emphasis was perhaps a factor in President Barosso's decision to move a large part of the responsibility for pharmaceuticals from Enterprise to Health.

However that switch does not change the dual nature of the industry to the EU. The relationship with DG SANCO is important, but so is the industrial policy towards the sector. How the change will impact remains to be seen, but in the short term it is unlikely to have an immediate impact.

At the same time, the pharmaceutical industry is a major player in the European research agenda, ploughing more than 20 per cent of sales – more than any other sector – back into research and development. Yet these are the bodies with a direct interest in the industry. There are also directorates for the internal market, regional policy and competition (the latter having shown an unhealthy interest in the sector with their anti-competitiveness inquiry during 2008-09). Then there is the European parliament, the European council and their representatives in Brussels, and stakeholders who may or may not view the industry with unbridled enthusiasm.

It is a veritable labyrinth. Expertise in understanding who is who and how the pieces fit together is a skill-set of its own, as is the patience to follow the often tortuous progress of dossiers and legislation. Policy makers do not have the time to deal with companies on an individual basis, nor would it be wise – heaven forbid that any individual company could be seen to influence policy in any favourable way. At the same time, the industry itself is less than homogenous, consisting of a wide range of manufacturers of differing origin, size and interests.

So what to do? How does the industry define, create and represent consensus, and ensure this consensus is heard and understood? Furthermore, how does it ensure that it is adapted to the frequent changes in the political weather, that it knows the activities of various stakeholders whose representations may not align, or even oppose yours?

This demands a long-term approach from individuals with a dedicated interest and a commitment to the policy environment. There is a place where you can find such people, already steeped in the industry culture. Therefore please make your contributions to your European Trade Association; be it EVM for vaccine manufacturers, Eucomed for medical device manufacturers, EBE for upcoming biopharmaceutical companies, or the mothership itself, EFPIA, the European Federation of Pharmaceutical Industries and Associations. EFPIA has a membership drawn from 40 leading manufacturers and more than 30 national associations.

The value of an effective trade body cannot be overstated. Not only are they equipped with the roadmap to find their way around, they have a contact network in place and are fully in tune with the rhythms. They also have specialist knowledge; real, in-depth understanding, of the issues of the day. The culture is almost vocational; there are individuals within EFPIA who have been in post for many years. In the recent sector by DG competition, the economic affairs team held literally hundreds of meetings to persuade the great and good of the flaws in DG competition's investigation. Importantly, they know where to go and who to see, and, with the backing of the majority of the industry, had the credibility to be taken seriously.

It would be no understatement to say that these efforts went a long way to blunting the impact of what could have been a highly damaging inquiry. It also does no harm that a good trade association can also call upon the best talents their members have to offer. Where deemed necessary this can go up to CEO level; in the case of the competition inquiry it frequently did. Business rivalry is left at the door.

It does not demand a challenge the size of the sector inquiry to mobilise the resources. EFPIA are currently supporting the industry in ensuring that the proposed legislation on animal welfare does not compromise European-based research. It continues to work on the pharmaceutical package, with industry taskforces and working groups driving response to all the main elements of the proposed legislation, organising and executing contact programmes, meetings and events to raise awareness of the industry's needs.

It is lobbying hard to make sure that health technology assessments are not simply used as cost-containment tools, and working with stakeholders to make research into new antibiotics viable. Then there is the response to the H1N1 pandemic threat, international trade relations, legal affairs, trademark infringements, EMEA relations; all of these a European political component.

Much of this may seem arcane and peripheral, but don't underestimate it. Already policymakers have recognised that the uptake of new and seemingly expensive treatments can be delayed by limiting the ability of clinicians to prescribe them freely. Given the tough economic circumstances, you can be certain that this downward pressure will continue. It is a truism that the earlier in the process you try to impact policy, the more successful you are likely to be; by the time policy reaches the implementation phase, there is little incentive or enthusiasm among architects to revisit it. By making industry issues a priority at the policy-setting phase, be it the access and diffusion of medicines, be it the proliferation of follow-on biologicals, you can make the political environment less challenging. As for healthcare being a member state responsibility, the EU expects its members to take its priorities on board. Your trade association can help ensure you're at the table, rather than on the menu.

There are no statistics on the numbers of European trade bodies, but it must run into the thousands. This does not mean Brussels is simply a talking shop, it is a recognition of the reality of the EU; it is growing in influence and reach, and working with the institutions is a highly skilled role. While individual companies can still 'do their own thing,' they cannot have the impact of a well-organised trade association. To be taken seriously, the industry needs to present a united front, and the EFPIAs of Europe help build consensus and ensure that efforts in Brussels are matched at national levels by associations alike.

Brussels will never be sexy, but it will continue to grow in influence. So make sure you are represented there, and make sure you support and engage with your trade association. They will fight your corner and punch above their weight while providing you with expertise that can make the arcane seem commonplace. If you don't, you can't blame the political climate. As Dr Kissinger observed, "The expert has his constituency – those who have a interest in commonly held opinions; elaborating and defining the consensus at a high level has, after all, made him an expert."

The Author
Colin Mackay is director of communications and partnerships at EFPIA and can be contacted at colinmackay@efpia.org

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