The Value of Engagement With Trade Associations in Policymaking, Regulation and Standardization

This article presents an argument for the value that trade associations bring to healthcare in terms of promoting best practices, policies, regulations and standards. The author defines trade associations and lays out their functions and the value of those functions for regulators and policy makers and also presents defining characteristics of good regulations and good policies. The focus is on foods for special medical purposes and the author shares examples from the work of the Medical Nutrition International Industry (MNI) in these areas.

Introduction
 
Trade associations play an important role in promoting best practice, informing public policies and regulations and developing standards. In the complex and fast-moving healthcare area, which is driven by innovation, data technologies, patient demand and budget constraints, policymakers and regulators face tremendous challenges to formulate effective, evidence-based and future-proof policies that serve the public interest. Productive engagement with stakeholders and trade associations is increasingly necessary. This article aims to present the value that trade associations bring to the debate, based on the experience of the Medical Nutrition International Industry (MNI).
 
Several questions can be posed regarding the role of trade associations in developing good policies, regulations and standards. Why is their involvement necessary, and how do they bring value?
 
What is a trade association?
 
There are many standard definitions for ‘trade association.’ Wikipedia proposes a definition that emphasizes the activities of a trade association:
 
“A trade association, also known as an industry trade group, business association, sector association or industry body, is an organization founded and funded by businesses that operate in a specific industry. An industry trade association participates in public relations activities such as advertising, education, lobbying and publishing, but its focus is collaboration between companies. Associations may offer other services, such as producing conferences, networking or charitable events or offering classes or educational materials. Many associations are non-profit organizations governed by bylaws and directed by officers who are also members.”¹
 
By contrast, the Cambridge English dictionary definition emphasizes the objective of the trade association:
 
“An organization that supports companies and employers of a particular type of industry and protects their rights.²
 
These definitions focus on the services trade associations provide to their industry. However, in the regulatory context, it is also important to look at the services that trade associations offer to the community and their stakeholders, including policymakers and regulators.
 
The Value of Trade Associations for Regulators and Policymakers
 
Although every trade association is different, they have similar characteristics enabling them to serve the community and bring value to their stakeholders.
 
Trade associations represent the “voice” of their sector.
 
Trade associations act as a main point of contact, thereby facilitating dialogue with industry. Regulators find it easier talking to a trade association, rather than to every company active in the sector. It is the role of the trade association to consolidate the industry viewpoint and make the link between industry and regulator and, by doing so, allow a structured, representative and transparent dialogue.
 
Trade associations provide access to a vast pool of expertise and information.
 
Trade associations have an extensive knowledge of their sector and a strong culture of knowledge sharing, which can be quickly passed on to regulators and policymakers.
 
Trade associations are well equipped to assess the impact of policy/regulatory measures on their sector and are, therefore, essential interlocutors for ensuring government action achieves its desired purpose. They can also provide access to a vast pool of experts and expertise. In the area of medical nutrition, for example, companies are well-connected and work with doctors, scientists, nutritionists, researchers and patient advocacy groups.
 
Trade associations guarantee a dialogue with respectable and trustworthy industry partners to regulators.
 
Trade associations have membership criteria to ensure their members are reputable and trustworthy businesses. Engaging with a trade association is a guarantee for regulators to deal with respected and committed partners.
 
MNI, for example, has detailed membership criteria to ensure its members are representative of the sector, respectable businesses, and committed to providing better care through better nutrition to all patients, across all care settings and age groups.
 
Trade associations facilitate multi-stakeholder cooperation.
 
Trade associations are part of a broader community and an “eco-system” that consolidates industry, regulators and citizens who are willing to work cooperatively with them to find solutions. They are generally able to support multi-stakeholders’ platforms, organize forums and conferences and develop joint positions on questions submitted by authorities. Rather than cultivating diverging and competing interests, trade associations are great allies with whom to work towards convergence and reach consensus.
 
Shaping an Adequate Environment: Key Principles
 
All sectors, including the medical nutritional sector, need a stable environment, one shaped through policies, regulations and standards.
 
What makes a good regulation?
 
According to Wikipedia, a regulation is “an abstract concept of management of complex systems according to a set of rules and trends.”³
 
The European Union defines a regulation as “a binding legislative act. It must be applied in its entirety across the EU.”⁴
 
The Cambridge English dictionary defines regulation as “an official rule or the act of controlling something.”⁵
 
The term regulation is, rightly or wrongly, associated with a negative connotation. One often hears about too much regulation, rigid regulation, red-tape, administrative burden, brake on innovation, etc.
 
The fact is that regulation is necessary in open market economies, including:
 

• to protect the rights and the safety of citizens/patients
• to create trust in the market, provide certainty and a level-playing field for business
• for the state’s control over the market players
• to translate legislation and policy into practical implementation

 
Getting regulation right is important; therefore, it is critical to understand what makes a good regulation.
 
The immediate response is very simple: a good regulation serves the public interest.
Beyond this principle statement, a few key subordinate principles are essential to make a good regulation.⁶ The principles outlined below are particularly important in the area of healthcare.
 
Evidence-Based
 
Regulations should be evidence-based. They should be based on science, rooted in proven facts and data, looking at health technology assessments and patient outcomes.
 
Necessity
 
The regulation should respond to a need, and the measures should be targeted to responding to that specific need, while avoiding side effects. The triangle (the regulators, the regulated community and the beneficiaries of the regulation) need to cooperate to agree on the need and on how to respond to it via a mix of binding rules and general principles.
 
Transparency
 
The regulation should bring confidence to the regulated system. This can be achieved by consulting all relevant stakeholders in a transparent and documented manner, following a public consultation framework.
 
Proportionality
 
A regulation should provide measures and rules proportionate with the risks of the issue at stake. The advantages of the regulation should outweigh the potential disadvantages of the regulation and avoid unnecessarily stringent measures. Compliance costs should be examined and minimized as much as possible.
 
Effectiveness
 
A regulation needs to work in practice. Consultation with the parties implementing the regulation is absolutely crucial to ensure legal instruments adopted can be easily understood, implemented and followed, without creating additional cost or burden. The regulated community should be given time and support to comply.
 
Flexibility (or Future-Proof)
 
Regulations should be flexible enough to allow for future developments. This is particularly important in the area of healthcare where regulation should allow and support innovation.
 
What makes a good policy?
 
The quick answer is a policy is good if it reaches its objectives.
 
However, policy is one of these “buzzwords” very commonly used without a clear understanding of its meaning. For instance, policy and regulation are often mixed up. This article will focus on public policies initiated and driven by government.
 
Wikipedia defines public policy as “the principled guide to action taken by the administrative executive branches of the state with regard to a class of issues, in a manner consistent with law and institutional customs.”⁷
 
The Cambridge dictionary uses the following definition:
 
“A government policy that affects everyone in a country or state, or these policies in general.”⁸
 
A major difference between a public policy and a regulation lies in the fact that policies are general, country-wide frameworks based on principles which affect the entire country through a set of principles, measures, actions and budget. A regulation aims to implement a policy by providing a frame to a given domain.
 
A good policy – as for a good regulation, includes:
 

• serves public interest
• has well-defined objectives
• benefits from a budget in line with its ambition
• has an implementation plan
• has evaluated its impact

 
What makes a good standard?
 
A quick answer to the question is: a standard is good if it is adopted. In healthcare, one would argue that a standard is good if it secures patient safety.
 
Other elements define a successful standard:
 

• clarity
• practicality
• ease of implementation
• consensus-based
• improve performance
• reduce risk

 
CEN, the European Committee for Standardisation, defines a standard:
 
“A technical document designed to be used as a rule, guideline or definition. It is a consensus-built, repeatable way of doing something.”⁹
 
Others define it as “an agreed way of doing something. It could be about making a product, managing a process, delivering a service or supplying materials—standards can cover a huge range of activities undertaken by organizations and used by their customers.”¹⁰
 
Typically, industry produces standards in order to create agreement on technical specifications for health, safety and the environment and to achieve interoperability.
 
Trade associations are key role players in standards development. They help to develop standards based on consensus among their members, ensure the standards reflect the reality of the market, and encourage and facilitate adoption by industry.
 
Why Trade Associations can Help Getting Policies and Regulations Right
 
When developing a regulation in the health sector, regulators must “tick” all the above boxes. To be successful, they have a vested interest in consulting all relevant stakeholders including industry.
 
Trade associations, such as the MNI, can help them define the need, run the sanity checks, run impact assessments, anticipate future developments, assess costs and risks, and help in crafting robust , fit-for-purpose, future-proof policies and regulations that will provide long-term benefits to patients and the healthcare system.
 
The Role of Trade Associations in Informing Policies, Regulations and Standardization: MNI Example
 
In the previous section, insights have been shared on what makes a good public policy/regulation or standard and how trade associations are equipped to inform these processes meaningfully.
 
This section will focus on the healthcare area and share examples of how the MNI, the trade association federating the medical nutrition industry at a global level, can bring value to the policy, regulatory and standardization process.
 
MNI Introduction
 
The Medical Nutrition International Industry (MNI) association¹¹ was created in 2005 to represent the voice of the medical nutrition industry at an international level.
 
MNI represents companies providing solutions for nutritional therapy, including oral nutritional supplements, enteral tube feeding (enteral nutrition via the gastrointestinal tract) and parenteral nutrition (intravenous feeding) as well as other actors operating in the medical nutrition market.
 
MNI works to achieve better care through better nutrition, across all ages and healthcare settings, and supports multi-stakeholder cooperation to improve the quality of nutritional interventions for patients.
 
Defining the EU Regulatory Framework for Medical Nutrition
 
The development of the regulatory framework covering medical nutrition, also called Food for Special Medical Purposes (FSMPs) in the EU, is an excellent example of consultation of the industry and its trade association (MNI).
 
Defining FSMPs: A Headache for Regulators
 
FSMPs are foods for special medical purposes. They are foods for helping patients meet their disease-related nutritional requirements when these cannot be met via the normal diet. FSMPs can take different forms, such as liquids, thickening powders, sip-feeds or naso-gastric solutions and must be used under medical supervision.
 
The first commercial products reached the market in the 1950s, yet their regulatory category status typically evolved from being put under drug law, then Food for Special Dietary Uses (FSDUs). Ultimately, by the 1980s and 1990s, they were properly defined as Foods for Special Medical Purposes (Codex Stan 180-1991)¹² supporting among other objectives their development as products for patients. Still, these ‘food products for patients’ often did not lose their “drug-like” characteristics or image.¹³
 
When the first products were commercialized, there was no understanding of these products and how they could support malnourished patients. It was, therefore, necessary to define the regulatory category with a clear definition.
 
However, defining such specialized products is not a simple task for those not involved in their development. MNI, as the association of manufacturers providing FSMPs contributed to the discussion and helped define the key characteristics of FSMPs. The definition for FSMPs is today enshrined in the so-called FSG regulation (EU)609/2013:¹⁴
 
“…food specially processed or formulated and intended for the dietary management of patients, including infants, to be used under medical supervision; it is intended for the exclusive or partial feeding of patients with a limited, impaired or disturbed capacity to take, digest, absorb, metabolise or excrete ordinary food or certain nutrients contained therein, or metabolites, or with other medically-determined nutrient requirements, whose dietary management cannot be achieved by modification of the normal diet alone.”
 
In addition, FSMPs are also classified in three categories in the European Commission Delegated Regulation (EU) 2016/128:¹⁵
 

• Nutritionally complete food with a standard nutrient formulation which, used in accordance with the manufacturer's instructions, may constitute the sole source of nourishment for the persons for whom it is intended.
• Nutritionally complete food with a nutrient-adapted formulation specific for a disease, disorder or medical condition which, used in accordance with the manufacturer's instructions, may constitute the sole source of nourishment for the persons for whom it is intended.
• Nutritionally incomplete food with a standard formulation or a nutrient-adapted formulation specific for a disease, disorder or medical condition which is not suitable to be used as the sole source of nourishment.

 
The article “Revising the EU FSMP Regulatory Framework: Laying the Foundation for Future Nutritional Patient Care”¹⁶ provides an excellent summary of the provisions covering FSMPs in the EU.
 
While the regulatory framework for FSMPs is now adopted and implemented in the EU, many countries and regions are looking to the EU for inspiration to build their own regulation on FSMPs.
 
MNI is regularly invited to share its expertise on medical foods in countries and regions where regulation is being considered, initiated or reviewed.
 
Industry also can add value by information sharing and promoting good practice and regulatory convergence across the globe.
 
Malnutrition and the Value of Medical Nutrition: Creating Awareness
 
Today, there is still very limited knowledge of medical nutrition among regulators and the general public. There is also little awareness of the burden of malnutrition, also called disease-related-malnutrition. It is MNI’s responsibility to inform and educate regulators and the general public to fill the knowledge gap.
 
The prevalence of malnutrition is very high across the globe. In Europe, malnutrition—or the risk of malnutrition—affects 25% of hospitalized patients^17-19 and one third of people living in the community.²⁰
 
In Europe alone, an estimated 33 million people are malnourished²¹ or at risk of malnutrition. The additional cost of managing the malnutrition of these patients is estimated to cost healthcare systems 170 billion Euros ($191.2 billion) per year.²²
 
Malnutrition is a serious public health issue. It is crucial that health authorities (government, policymakers, regulatory authorities) take measures to manage malnutrition effectively. These measures should prevent malnutrition and provide access to nutritional therapies, including FSMPs.
 
MNI has developed case studies to help authorities and the general public understand medical nutrition, the indications for using such products, the different forms that they can take to fit healthcare professional and patient needs, why they should be used under medical supervision, and the science behind these products.
 
More recently, MNI has published a comprehensive dossier entitled Better Care through Better Nutrition: Value and Effects of Medical Nutrition.²³ The Dossier is a unique and comprehensive summary of the evidence base on the prevalence of malnutrition and the value and effects of medical nutrition. Data are presented by age group, healthcare setting, and, where possible, by patient group. With forewords from key stakeholders, it is a credible and valuable resource to address malnutrition and the health and economic benefits of nutritional care. The dossier is also available in a summarized booklet for a lay audience - Figure 1.
 
Figure 1. Medical Nutrition Dossier



 
To date, no one else has provided such an extensive and documented summary on the burden of malnutrition. MNI believes much more needs to be done to support malnourished patients and is committed to supporting health authorities in articulating effective nutritional care policies.
 
Supporting the Nutritional Care Community and Fostering Multi-Stakeholder Dialogue to Inform Nutritional Care Policies
 
As mentioned in the first part of this article, trade associations are willing to work with other stakeholders. MNI takes multi-stakeholder cooperation very seriously and supports activities building a vibrant and empowered nutritional care community.
 

• In 2008, MNI launched the MNI Grant to raise awareness on malnutrition and to reward initiatives tackling malnutrition at national level. Over the years, the MNI Grant has supported and stimulated ambitious initiatives which have contributed to improving nutritional care policies at national levels.

 

• MNI is an active member of the Optimal Nutritional Care for All (ONCA) campaign, a European public-private partnership that promotes screening for malnutrition and good nutritional care. The campaign started in eight countries in 2014 and is now rolling out in eighteen countries. In each country, stakeholders with an interest and expertise in nutritional care (including the academic world, authorities, patient groups and manufacturers) work together to drive and enhance nutritional care policies and provide access to quality nutritional care for patients. This campaign was described in this review in the article Innovating Patient Driven Nutritional Care Across Europe: The Optimal Nutritional Care for All (ONCA) Multi-Stakeholder Initiative.²⁴

 

• MNI also cooperates with the clinical and academic worlds. For instance, MNI has a long-standing cooperation with the European Society for Clinical Nutrition and Metabolism (ESPEN). The cooperation focuses on initiatives to improve clinical practice, such as the dissemination of ESPEN guidelines or initiatives aiming at strengthening the education of medical students on nutrition. Every year for the last ten years, MNI, ONCA and ESPEN have joined forces to bridge the gap between the academic/clinical worlds, and health decision-makers by inviting senior officials to the ESPEN Congress in a spirit of knowledge sharing.

 
Promoting Adoption of International Standards That Reflect Common Practice and Ensure Patient Safety: Case Study
 
Background
 
Enteral feeding therapies rely on devices to administer nutrition solutions to patients. These include giving sets, feeding tubes, syringes, pumps, connectors, etc. known as enteral feeding systems – Figure 2.
 
Figure 2. Overview of an Enteral Feeding System


 
The design and the testing of enteral feeding systems will be described by an international standard: ISO 20695.²⁵ The draft ISO20695 standard reflects current practice in the market and it is being increasingly adopted around the globe with a proven track record of guaranteeing the safety of patients on enteral feeding by minimizing risks linked to misconnections between various devices for different medical applications.
 
Threat
 
The standard was under review as part of the regular ISO standards creation process, and there were calls to change the design of certain devices. MNI analyzed the situation and anticipated how a modification to the design of devices would create confusion among users:
 

• Users would need to be trained to the new design.
• Users would need to phase two or more different designs, which might not be interconnectable with each other. This might result in the impossibility to start a feeding therapy; or in the need to replace parts of the enteral feeding system or to use adapters to facilitate a connection.
• Using adapters should be avoided as this might cause confusion or even distress and again opens the possibility for accidental misconnections again between systems for different medical applications leading to potential safety risks for the patients.

 
Action
 
MNI and the Global Enteral Device Supplier Association (GEDSA)²⁶ joined forces to support the adoption of ISO 20695 and developed a joint position paper.²⁷
 
The adoption of the standard will be an important and much-needed milestone to provide a unique set of rules at the global level for enteral feeding devices. It will provide clarity and certainty for uses and will strengthen safety of patients on enteral nutrition.
 
Outcomes
 
As this article goes to press, it is not possible to share a clear outcome as the review process for ISO 20695 is ongoing. However, it is important to note that the active involvement of trade associations such as MNI and GEDSA have been instrumental to federate industry around an international standard, providing for a single design for enteral feeding devices worldwide.
 
Conclusion
 
Trade associations are key actors on consultations to have a balanced and future proof policies, regulations and standards. Cooperation between industry associations and government is very important for the policy making process. In the healthcare sector, there are many ways that trade associations can make an impactful and beneficial contribution to their community including patients and healthcare professionals.
 
In turn, trade associations can gain government’s and stakeholders’ trust and respect by following a few basic guidelines:
 

• act as a consolidate, co-ordinated voice of the sector
• provide evidence-based information
• share commercially neutral positions that reflect the consensus views of the sector
• work towards convergence
• be trustworthy, patient and transparent
• support the community

 
Trade associations should continuously ask themselves: How can we participate to make the process better and ensure my input helps to reach the objectives set by the community?
 
References
 

1. Wikipedia. Trade Association. https://en.wikipedia.org/wiki/Trade_association. Accessed 5 June 2019.
2. Cambridge Dictionary. Trade Association. https://dictionary.cambridge.org/dictionary/english/trade-association. Accessed 5 June 2019.
3. Wikipedia. Regulation. https://en.wikipedia.org/wiki/Regulation. Accessed 5 June 2019.
4. Regulations, Directives and Other Acts. https://europa.eu/european-union/eu-law/legal-acts_en. Accessed 5 June 2019.
5. Cambridge Dictionary. Regulation. https://dictionary.cambridge.org/dictionary/english/regulation. Accessed 5 June 2019.
6. OECD Council Recommendation of the Council on Regulatory Policy and Governance – 2012. Accessed 5 June 2019.
7. Wikipedia. Public Policy. https://en.wikipedia.org/wiki/Public_policy. Accessed 5 June 2019.
8. Cambridge Dictionary. Public Policy. https://dictionary.cambridge.org/dictionary/english/public-policy. Accessed 5 June 2019.
9. European Committee for Standardization. What is a Standard. https://www.cen.eu/work/ENdev/whatisEN/Pages/default.aspx. Accessed 5 June 2019.
10. About BSI. Business Standards Company (BSI) website. https://www.bsigroup.com/en-GB/about-bsi/. Accessed 5 June 2019.
11. Medical Nutrition International Industry Association website. https://medicalnutritionindustry.com/. Accessed 5 June 2019.
12. Codex Standard for the Labelling of and Claims for Foods for Special Medical Purposes. Accessed 5 June 2019.
13. Binzak Blumenfeld B. “A Long-Awaited Update to the FDA Draft Medical Food Guidance.” November/December 2013. www.fdli.org. Accessed 5 June 2019.
14. Regulation (EU) No 609/2013 of the European Parliament and of the Council of 12 June 2013 on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control and repealing Council Directive 92/52/EEC, Commission Directives 96/8/EC, 1999/21/EC, 2006/125/EC and 2006/141/EC, Directive 2009/39/EC of the European Parliament and of the Council and Commission Regulations (EC) No 41/2009 and (EC) No 953/2009. Accessed 5 June 2019.
15. Commission Delegated Regulation (EU) 2016/128 of 25 September 2015 supplementing Regulation (EU) No 609/2013 of the European Parliament and of the Council as regards the specific compositional and information requirements for food for special medical purposes. Accessed 5 June 2019.
16. Bushell C and Ruthsatz M. “Revising the EU FSMP Regulatory Framework: Laying the Foundation for Future Nutritional Patient Care.” Regulatory Focus. July 2018. Regulatory Affairs Professionals Society.  
17. Russell C and Elia M. “Nutrition Screening Week in the UK and Republic of Ireland in 2011. Hospitals, Care Homes and Mental Health Units.” Redditch, BAPEN. 2012.
18. Schindler K, Pernicka E, Laviano A, Howard P, Schutz T, Bauer P, et al. “How Nutritional Risk is Assessed and Managed in European Hospitals: A Survey of 21,007 Patients Findings from the 2007-2008 Cross-Sectional Nutrition day Survey.” Clin Nutr. 2010;29(5):552-559.
19. Meijers JM, Schols JM, van Bokhorst-de van der Schueren MA, Dassen T, Janssen MA and Halfens RJ. “Malnutrition Prevalence in the Netherlands: Results of the Annual Dutch National Prevalence Measurement of Care Problems.” Br J Nutr. 2009;101(3):417-423.
20. Kaiser MJ, Bauer JM, Ramsch C, Uter W, Guigoz Y, Cederholm T, et al. “Frequency of Malnutrition in Older Adults: A Multinational Perspective Using the Mini Nutritional Assessment.” J Am Geriatr Soc. 2010;58(9):1734-1738.
21. Ljungqvist O and de Man F. “Under Nutrition: Major Health Problem in Europe.” Nutr Hosp. 2009;24(3):368-370.
22. Ibid.
23. Better Care Through Better Nutrition: Value and Effects of Medical Nutrition. A Summary of the Evidence Base. 2018 Edition. Accessed 5 June 2019.
24. De Man F, Smit C and Ruthsatz M. “Innovating Patient Driven Nutritional Care Across Europe: The Optimal Nutritional Care for All (ONCA) Multistakeholder Initiative.” Regulatory Focus. October 2017. Regulatory Affairs Professionals Society.
25. ISO/DIS 20695.2. Enteral Feeding Systems: Design and Testing. International Organization for Standardization (ISO) website. https://www.iso.org/standard/68853.html. Accessed 5 June 2019.
26. Global Enteral Device Supplier Association (GEDSA) website. http://gedsa.org/. Accessed 5 June 2019.
27. Joint MNI GEDSA Position Paper on ISO 20695 Standard. 15 April 2019. https://medicalnutritionindustry.com/files/user_upload/intranet/position_papers/Joint_MNI_GEDSA_position_paper_ISO_20695.pdf. Accessed 5 June 2019.

 
Disclaimer
 
This article reflects the personal opinion and experience of the author. It should not be construed as an official position by any organization with which the author is affiliated.
 
About the Author
 
Léa Coulet is executive director at the Medical Nutrition International Industry, the trade association for the medical nutrition industry, based in Brussels. Coulet has more than 15 years of experience in policy and regulatory affairs in a wide range of health issues, including nutrition, public health, pharmaceutical policy, market access, global health, standardization and medical technology. She can be contacted at leacoulet@medicalnutritionindustry.com.
 
Cite as: Coulet L. “The Value of Engagement with Trade Associations in Policy-Making, Regulation and Standardization.” Regulatory Focus. June 2019. Regulatory Affairs Professionals Society.