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Business intelligence and regulation – a marriage made in heaven?

Regulation is a topic that divides opinion in the world of healthcare informaiton, with some seeing it as spreading best practice, while others claim the ambiguity of different rules causes confusion 

Business intelligence & regulation – a marriage made in heaven? The European market research industry is one of the most heavily regulated in the world. It seems new regulation is introduced each year and, for some in the industry, this is seen as adding yet more unnecessary hurdles for practitioners to jump.

For those subscribing to this view, there is a perception that too many regulations could harm market research and, more fundamentally, undermine or 'get in the way of' developing approaches and techniques that will generate better quality information upon which clients can base their business decisions.

Others see the inexorable rise of regulation as delivering an undoubted set of benefits to the industry. Having a set of common and stretching standards that evolve in line with the changing market environment can, it is argued, only help in spreading good governance. As with most polarised arguments, there is probably a degree of validity to both points of view.

Nonetheless, the clients for market research offerings are under increasing regulatory pressure across all elements of the discovery, development, distribution and marketing of their medicines. It is natural that they want the companies they go to for their business intelligence to follow and be bound by a clear and transparent set of ethical guidelines, even without legal force. These are set in a framework that all suppliers in the business information industry live up to and abide by.

This means that there is one less thing that the pharmaceutical industry needs to worry about in its efforts to build a better reputation in the eyes of legislators and other key stakeholder groups. Having suppliers who undertake market research with their customers and other audiences while bound by a clear, ethical and accountable regulatory framework can only be good.

European rules
In Europe, the business intelligence and market research industry is governed by pan-European market research regulations drawn up and disseminated by EphMRA (the European Pharmaceutical Market Research Association). It is fair to say that the rules, as they stand, do leave scope for some interpretation and, equally, some misinterpretation.

On the one hand, all market research suppliers are working to a standard set of guidelines, which can help reduce red tape and an amount of 're-inventing from first principles' for each and every project being undertaken. On the other hand, some degree of ambiguity in the guidelines leads to there being scope to increase confusion and potentially cause errors, especially when conducting pan-European research.

UK situation
The three main regulatory bodies that govern how pharmaceutical market research is conducted in the UK are The Market Research Society (MRS), The British Healthcare Business Intelligence Association (BHBIA) and The Association of the British Pharmaceutical Industry (ABPI), with each providing guidelines. The BHBIA governs pharmaceutical market research and combines the MRS and APBI guidelines – among other regulations – to ensure that pharmaceutical research guidelines comply with, and are aligned to, more general market research regulation, as well as being compliant to the pharmaceutical industry guidelines. The UK is also governed by the pan-European regulation from EphMRA.

The market research regulatory process in the UK is very similar to that of other European countries in that there are typically one or two set regulations to which researchers must adhere. This is in addition to the overarching guidelines from EphMRA. All European countries are also bound by EU laws such as the EU directive 2011/83, the EU Regulation on Community Procedures and the EU Electronic Communications Directive designed to uphold ethics and best practice in market research.

There is a fairly common perception that UK regulation is the strictest in Europe, but this is not the case. For instance, in Spain, the trade organisation Farmaindustria has to approve all research, and pharmaceutical companies must declare all research externally. This can create extra processes which are extremely restrictive, greatly extend project timelines and potentially make market research unfeasible.

Irrespective of country by country differences, however, the single biggest development in the healthcare market research world over the last few years has been the increased regulation surrounding the reporting of adverse events. 

So, with market research being regulated in terms of both how research should be conducted as well as what is reported during the research process, it is also important to discuss how regulation around the reporting of adverse events applies at any and all stages of the market research process.
 
Adverse event reporting
Adverse event reporting, or the reporting of an untoward medical occurrence for a patient administered a medicinal product or medical device, is evolving year on year. The BHBIA and EphMRA produce guidelines on adverse event reporting, but market researchers must also know each individual client's adverse event reporting requirements and ensure they are followed too, treating BHBIA and EphMRA requirements as a 'minimum standard.' 

Adverse event reporting has undoubtedly had a positive impact on market research, helping to spread best practice through the industry. It is argued that the addition of adverse event reporting during market research projects running alongside existing medically grounded adverse event reporting systems has saved, and is potentially saving, lives even at the risk of over-reporting incidents.

Making the process an integral part of market research is commonplace in all European markets, as it is a requirement of worldwide health authority regulation.

Pharmaceutical companies can, and should, request to audit market research agencies to ensure that their research is fully adverse event compliant.

Rules on market research 
Indeed, it is argued that the increased regulation seen since the 1980s has had a substantive and positive impact on the healthcare market research industry. The main benefits and implications can be broadly summarised as follows:

  • Regulation helps to prevent pharmaceutical disasters: Market research regulation, particularly adverse event reporting, can play a vital role in preventing pharmaceutical disasters
  • Regulation leads to increased corporate responsibility: The fact that pharmaceutical companies and the research agencies they partner are audited has greatly increased levels of corporate responsibility
  • Regulation results in increased training: When new regulation is introduced, companies must ensure that they change their ways of working and increase training accordingly to ensure they are still compliant and above question at every stage of the process
  • Regulation develops better ways of working: Companies have to ensure that they are compliant with any new legislation that is introduced. Often, they will take this opportunity to re-examine their ways of working, which can lead to better working practices being introduced that benefit the firm and then filter down through the industry
  • Regulation leads to greater transparency: Increased regulation and the fact that pharmaceutical companies are audited, explain their research and are accountable has resulted in much greater levels of transparency
  • Regulation develops the market research industry: In any industry, complacency leads to poor performance. Ever-evolving regulation means that the industry cannot rest on its laurels and has to develop and improve to meet the new challenges.


Unnecessary red tape? 

There are some drawbacks resulting from myriad regulations that govern European market research. The fact that guidelines, from whichever trade association or professional body, can sometimes be open to interpretation may create a level of uncertainty and concern for the companies employing research agencies.

Every pharmaceutical company has a different interpretation of the codes of conduct and their expectations for market research. It is important that they work in close partnership with research agencies to ensure that there is clarity on the processes that agencies are using to reduce confusion. Indeed, mindful of these issues, it is worth noting that the BHBIA and EphMRA both offer a helpline service for questions on the guidelines.

Market research agencies are trying to find consistency in the research process and very often liaise with the medical departments of their pharmaceutical clients. This can, however, be complicated by the different interpretations of the various regulatory guidelines that may be in play in each country. It could be beneficial for research companies to install a compliance manager to help guide clients through the range of regulations that exist not just in Europe, but globally. 

The future
There is a danger that too much new legislation in Europe could tip the balance the other way and become red tape that hinders the industry. Pharmaceutical companies and research agencies must continue to work with regulatory bodies to ensure that this does not happen and regulation continues to be a benefit to the industry.

Although there is no crystal ball showing the future, it is clear that regulation is considered vital to the benefit of the industry and will always have a role in pharmaceutical market research. Regulation has shaped pharmaceutical market research for the better, helping to spread best practice, uphold ethics and prevent pharmaceutical disasters. The market research industry must embrace regulation and continue to develop ways of working that will help the industry to progress and spread best practice for the benefit of the industry as a whole.

Jane Shirley, Insight Research Group
The Author
Jane Shirley
is joint group managing director of Insight Research Group

20th February 2012

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