The Eighth International Pharmaceutical Compliance Congress took place in Dubai, UAE earlier this year. The conference featured many useful programs and impressive speakers that highlighted how compliance is an increasingly global challenge. We recently featured coverage of India’s healthcare compliance challenges and opportunities. Today, we are focused on potentially an even more complex marketplace: Middle East and Africa (MEA), and the MEA Code of Promotional Practices.
MEA Business Outlook
- 60+ countries
- Population of 1.4 billion
- Large, young, and growing population, with an expanding middle class
- Large disparity in wealth, educations, and healthcare systems
- Burden of diseases – This area is “carrying the weight of communicable and non-communicable diseases”
- Relatively large pharmaceutical market of over $50 billion, but “extremely atomized.” No market by itself could carry the weight of the entire area.
The expected growth in pharmaceutical sales in the MEA is projected to more than double the global growth. Nearly 10% of global growth in the next few years will come from this area. IMS Health ranked eight MEA countries as “frontier markets,” which have high predicted growth rates.
Complexity of Operating in MEA
Despite the growing population and need for pharmaceuticals in the Middle East and Africa, Nabil Daoud, Eli Lilly’s regional Vice President in the Middle East, noted several risks associated with operating in the expansive area.
- High corruption index in certain areas, and a lack of transparency in procurement methods. Furthermore, the risk is compounded when companies must interact with distributers and intermediaries.
- Enforcement may not be able to keep pace with new laws- the regulations may be in place, but not the proper staffing or resources. Or, in some cases there actually are no applicable laws or codes to regulate the pharmaceutical products promotion and practices.
- Conflicting regulations can add to the difficulty of building clear compliance principles.
- Business model- In many of the smallwe MEA counties, pharmaceutical companies are not legally present on the ground. They operate through distributors which increases the risk level. Furthermore, companies must have policies for training distributors on the ground.
- Role of pharmacies- Pharmacies in most of the territories are legally only allowed to dispense medication. However, in many African and Middle Eastern countries, there would be little or no checking of a specific prescription. This is leading to pharmacists substituting the role of prescribers. Daoud cautioned companies not to be tempted to use these dispensing pharmacies for improper sales.
- Growing role of local companies- Sales teams from multinational companies bound by a strict set of ethics often have to compete with local companies who do not. Local companies are growing at a very high rate. This makes the market very difficult and unpredictable.
MEA Code of Promotional Practice for Pharmaceutical Compliance
The Middle East and Africa Code of Promotional Practices is a set of guiding principles that are developed and enforced by the pharmaceutical companies to self-regulate marketing and promotional practices. Currently the MEA Code is enforceable among 16 pharmaceutical companies in the region. The first addition was created in 2005, and it was revised in 2010. The Code is aiming to foster an environment where the general public can have trust and confidence in what is sometimes considered an untrustworthy industry.
The MEA Code covers all methods of promotion. It is initially inspired by the IFPMA Code, but tailored to specific issues faced in the MEA regions:
- Oral and written communications
- Journal and direct mail advertising Promotion
- Events and hospitality
- Education and sponsorships of HCPs
- Gifts and inducements
- Non interventional studies of marketed medicines
- HCPs paid services (speaking, advisory board)
- Pharmaceutical staff practices
- Relationships between member companies and patient organizations
- Internet usage
- Grants and donations
- Samples distribution
In parallel, many companies have engaged in initiatives not yet covered by the Code, including anti-corruption programs, local fair market value benchmarking exercise, and at the most sophisticated end, disclosure and transparency initiatives.
Key Challenges Encountered Since the Enactment of the Code
Daoud noted that initially the initiative encountered pushback because it made for an unfair playing field. Early on, the majority of efforts focused on education of HCPs and medical association on the changing ethical standards. This included “simple things like hospitality matters and selection of venues for congresses.”
Another continuing challenge is that only 16 companies are adhering to this Code, while local industry in some countries makes up more than 50% of the market. Daoud stressed “transitioning this initial frame of self-regulation to embed it into government regulation.” For example, Daoud noted that Saudi regulators are imbedding the compliance code into law for all local industry as well. “This is a great model to replicate,” states Daoud, “because we can’t operate in a bubble:” Multinational and generic standards must be the same.
According to Daoud, most important is the need for countries in the area to form trade associations. Currently, there are only formal legal association in a small selection of countries (including the UAE, Morocco, Egypt, South Africa). In other markets of the MEA, industry isn’t organized into a legal trade association in the country. Associations present an opportunity for making a wider Code with enforcement potential at the local level. Currently the Code is not attached to a local legally established trade association except in the short list of countries.
Thus, Daoud sums it up to say that while education is important, the education needs to be “anchored” into either a trade association or government regulation to provide more teeth.
Key 2013 Initiatives
Knowing the limitation of enforcement, the Local Ethics Review Board (LERB), which Daoud is a part of, focused on facilitating wider external outreach. In 2013, LERP added updates to the Code to specifically capture what was acceptable promotional behavior and what wasn’t.
LERB’s next education initiative focused on sending letters to medical associations reinforcing the location for medical events and congresses early on the process. Finally, Daoud discussed the development of a short video presenting the pharmaceutical industry mission and walking through the principles at the heart of the Code. The video will be presented before events and congresses to set the tone for ethical practices and self-regulation (in fact it was shown at the international compliance congress earlier in the day).
South Africa Code as Model
Daoud says that South Africa’s legally established trade association provides an example of strong initial self-regulation embedded also with government. In 2013, they finalized their code of ethics and a strong enforcement mechanism, where problems go up the chain from the association, to the Department of Health. South African companies ultimately can face sanctions as severe as deregulation.
Code Revisions Going Forward
Daoud summarized LERB’s ongoing efforts into three categories:
(1) Communications: maximizing education and targeting external stakeholders through letters and the compliance video described above.
(2) Code revisions to deal with the following
-Pharmacists dispensing with and without
-Samples should not be left with pharmacists
–Patient support programs- education process
-Transparency- Daoud says it will be a very long journey to reach a point where disclosure of payments to HCPs is required in MEA.
-Dealing with 3rd party.
(3) Enforcement Mechanisms: looking to replicate South African mechanism of a local association and self-regulation in parallel with government enforcement.