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What Makes a Good Patient Advocacy Strategy in Russia and CIS?


Nick Hicks looks at the challenges of devising a patient advocacy strategy amid the complex political, cultural and regulatory landscape of Russia and CIS.

Nick Hicks looks at the challenges of devising a patient advocacy strategy amid the complex political, cultural and regulatory landscape of Russia and the CIS region.

As growth in traditional markets continues to flatten, firms are shifting more towards emerging regions like Russia and the CIS as fundamental growth drivers. Despite sanctions, the Russian Pharmaceutical market remains attractive being one of the fastest-growing in the world, with annual growth of 9% with a projected value of 21 billion dollars in 2019(1). There are large unmet medical needs. Improved diagnostics will lead to better detection of non-communicable diseases and life style disorders, such as diabetes, cancer and cardiovascular diseases.

A challenging business environment includes controlled pricing, promotion of cheaper generic alternatives and a far more rigid regulatory environment with greater obstacles to bringing innovative drugs to market than in the West.

Though advocacy communications is now a recognised part of a company’s access plan in established markets, there is not a clear cut path to success in creating an advocacy strategy. There are already many different factors influencing the engagement pathway a company takes with a patient group to communicate and engage with them and other stakeholders; within the region these are even more complex due to the political, cultural and regulatory differences.  Companies must view and shape their advocacy strategy using a very different set of lenses to those used in the West. The panel discussed three factors that can shape a company’s advocacy strategy in the short term and proposed several ways of moving forward.

No well-defined compliance regulations or framework
Existing legislation only provides a description for the role of patient groups. Proposed new legislation on working with pharma is working its way through the governmental system but there is no date when these will become law. Companies are likely to create their own compliance systems. Seen as a challenge and an opportunity by the panel since different company practices could lead to confusion and misunderstanding. But also the opportunity to develop a strong foundation of ethical compliant working built on trust, transparency and common aims.  

The AIPM (Association of International Pharmaceutical Manufacturers), an EFPIA member since 2013, has been adapting key compliance regulations for HCPs to the Russian market and will soon follow up with patient group guidelines. One responsible approach discussed by the panel was the possibility of companies working through the AIPM to invite different patient groups together to discuss how best to set up an ethical working approach. The EFPIA Code of Conduct (2) and the IAPO (3) (International Alliance Patients Organizations) consensus framework for ethical working being used as the discussion frame work.

Different dynamics of advocacy landscape and patient groups
Time spent identifying the key influencers and stakeholders is one of the most important parts of an advocacy plan as understanding their interactions shapes a company’s advocacy strategy. Thorough analysis of each group’s priorities, policies and positions provides insight into the issues that matter to patients. But regionally these interactions are complex and often, opaque, making it difficult to find a meaningful starting point. Tracking appropriate international initiatives can easily be undertaken internally though to identify suitable opportunities.

One such example is EUPATI(4), (European Patients Academy on Therapeutic Innovation), an EU funded initiative which aims to increase capacities and capabilities of patients and patient organizations. EUPATI provides an independent forum for patient groups and industry to meet. Russian is one of the working languages allowing far greater opportunities for Russian based companies to engage  with patient groups than would normally be possible.

Regionally the government plays the role of customer, regulator and partner. Governmental expectations on the behaviour of patient groups are directive with more acquiescent conduct sought. Patient groups are expected to be loyal to the government (who may also fund them) and its schemes and actions even though they may be detrimental to the group’s aim and purpose. The expected tolerance required to  be shown by patient groups in accepting faults in the government system  only contributes to a more passive “tick box” involvement. This in turn creating greater challenges for a transparent, trust based partnership approach based on common aims with pharma. The impact of such a cultural difference on adoption of a global advocacy strategy must be taken into account during early planning.   

Geopolitical tensions have resulted in the government imposing restrictions on the number and funding of NGOs including patient groups by overseas companies.  Budgets have been decreased by over 350% with resulting staff reductions. A large number of groups have ceased to exist, often there is no patient group representation in certain diseases. Companies may need to support patient groups becoming re-established but this can lead to accusations of company control if only one company is involved. Russian companies are not are not affected by the new legislation, complicating the mix even further.  With the deteriorating economic situation in the Region, “Import substitution” and  “localization”, two major trends and buzzwords will take on more significance. The price pressure on international pharma will only increase so that local companies will receive full support from the government in public tenders.

Physicians running patient groups are more common who often have multiple roles and touch points reflecting these different responsibilities.  This creates a different dynamic for companies wish to partner with a group where the clinician is also the main contact point with the organization. Patients’ organizations bring their own unique knowledge on the challenges of living with a disease which risks being missed by bypassing direct engagement with the patient group. Understanding such insights provides valuable pointers to areas of common interest that build can build trust and value for both the company and the patient group.

Company culture and therapeutic area
For many companies working with patient groups is a new activity and the country manager must clearly see the role of advocacy. Conventional sales metrics cannot be used to measure advocacy which will need to be seen as a strategic investment, not a bottom line expense. A perspective which short term, will face challenges when compared against traditional sales focused activities.

The level of institutional relationship existing with the patient group dictates the speed with which an advocacy partnership can be established.  In a new disease area, a company must build up a trust/transparency based approach. This takes normally about three years.  Finding the right mix of hard/soft metrics and KPIs will make justifying advocacy spend to senior management much easier. Alignment of objectives with the wider company programme becomes key.  

Implications and challenges

Established markets now adopt a patient centric approach with advocacy strategies towards beyond the pill initiatives. Short term, this is unlikely to influence advocacy within the region which has to first address many other factors. The panel did identify defining advocacy within a regional context as important as this will help allocation of resource and measurement of success. A commonly used version of advocacy within mature markets defines advocacy as  building  mutually-beneficial partnerships  with all stakeholders in a position to influence the successful uptake and use of medicines, services or devices - be it patients, health care professionals,  professional  associations, payers, ministers etc.  Implicit within it is (i) the need for a planned approach to move patient groups, clinicians and nurses to a position where they are effective advocates (ii) an understanding of the compliance parameters & ethos within which a company can engage with external stakeholders in advocacy activities.

It remains unclear what path the reimbursement in Russia will take and how the current budget constrains will affect patients’ access to innovation. HTA, where it occurs, is still in its infancy and the patient specific pathway infrastructure seen in for example TLV, G-BA or NICE is non-existent. The uncertainty over the focus for further reimbursement has four possible options; socially unprotected categories, the working population, those at a severe stage of diseases or those with treatable conditions.  Advocacy strategies will be different for each path. Short term, companies will focus on generic type advocacy strategies such as capacity building and disease awareness until greater clarity has been achieved.
Patient groups are generally not well developed notable exceptions being MS, Cancer, HIV and Diabetes. Few patient groups will have worked with pharma and managing expectations and ensuring understanding of the division compliance has created in project funding and partnering will need careful handling. Pharma may have also limited experience in working with patient groups. Developing the skill of balancing the medical science with the empathy necessary for effective working with patient groups will become an important internal proficiency.  Moving the patient groups through the various development stages in order for them to become involved in advanced advocacy strategies is not going to happen overnight and without an agreed set of compliance rules companies are likely to proceed with caution.
Two ways forward in the short term1. Do No Harm – avoid two common pitfalls

Patient groups say that problems with Pharma begin when transparency and communication fail leading to suspicions, creating a lack of trust. So the old medical maxim of, “First do no harm”, provides a good working philosophy for companies just setting out in establishing relationships with patient groups. One of the main pitfalls for creating lack of trust is reaching out to a patient group before internal clarity on what a company wants to achieve has been reached.  “It’s always too early then it’s too late” means that activities are not thought through in sufficient detail in the early stages of the planning process leading to a mis- match of shared aims. Then rushed in at the last moment or pursed halfheartedly, to the detriment of all concerned.

Many relationship management problems with patient groups are caused by having multiple contact points within a company. Establishing responsibility for managing stakeholders is crucial to ensuring credibility and consistency of message as well as appropriate timing and impact of communication. Clear roles, responsibilities & points of contacts are vital for effective patient group co-ordination. A single point of contact allows early identification of potential issues or discrepancies.
The other pitfall to avoid is using an inappropriate engagement strategy for the current capacity and development of the patient group. Using the incorrect strategy leads to a mismatch of aims and disappointment in outcomes from both sides. Going too fast in the early partnership stages often leads to problems so progressively develop the type of strategy in line with where the patient group currently finds itself and the operational objectives. 

2. Leverage Western Patient Groups Experience

Companies must make more use of patient group working best practice. Success with patient groups in the early stages is likely to come by starting small on well-defined projects which aim to build trust and credibility. Western patient groups are a very useful resource for training their Russian and CIS counterparts. Facilitated invitations between relevant groups to participate in training provide a responsible and high value service which some Russian based companies are already taking advantage of and helping such meetings occur.

This was the first time the Forum covered working with patient groups. The panel discussions showed that a Western approach is not going to work in such a complex and culturally different market place without considerable modification. Advocacy has first to show what it can do for a business and to do this it must part of an integrated plan and approach. Getting there is going to take time and the ongoing financial and geo political situation will continue to act as constraints. What was clear was the commitment for Pharma to work with patient groups based on a strong ethical foundation of trust and common aims.

Ten tips for developing an advocacy strategy in Russia and CIS

  • Obtain senior management buy in on long term, non-sales advocacy approach.

  • Have a compliance system aligned with company culture and history in place before reaching out to patient group.

  • Understand advocacy within your specific company environment and context.

  • Understand where advocacy can have the biggest impact on the business.   

  • Use and adapt global material such as compliance contracts.

  • Ensure internal clarity on aims of working with patient group is understood.

  • Resource level to successfully implement an advocacy initiative is identified.

  • Do the landscape mapping internally; it is always work in progress.

  • Start small. Build trust and reputation first by focussing on patient group needs.

  • Have a consistent point of contact.

References and links

1.    IMS Health Market Prognosis March 2015.
2.    http://transparency.efpia.eu/uploads/Modules/Documents/code_po2011.pdf
3.    https://www.iapo.org.uk/consensus-framework-ethical-collaboration
4.    EUPATI http://www.patientsacademy.eu/index.php/en/

About the Author

Nick Hicks is director of Commutateur. He facilitated a series of panel sessions featuring patient groups and pharma representatives on establishing an ethical and compliant advocacy strategy within Russia and the CIS at the annual Russian Pharma Forum, St Petersburg, in May 2015.

The date for next year’s Russian Pharma Forum meeting is May 17–19, 2016.



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