At the World Orphan Drug Congress in Boston, Paul Stanton, Senior Director, Inceptua Early Access, had the opportunity to present on a topic of critical importance: “Considerations for Running Early Access Programs (EAPs) in Sanctioned Countries.” The presentation aimed to shed light on the key factors that Pharma, Biotech, and Service Providers need to consider when evaluating their standard medicines access practices with the goal to ensure that patients in heavily sanctioned countries can receive innovative medicines.

In this Q&A, Paul Stanton delves deeper into the considerations and strategies for successfully running EAPs in these challenging environments.

How many patients worldwide are affected by the challenge of treating those in sanctioned countries?

To set the scene, 1/3rd of the world’s population live in sanctioned countries (based on US, EU, or UN sanctions).  Whilst there are varying degrees in the number and types of sanctions, 2.6 billion potential patients are not getting access to the medicines that they need.

What are sanctions and trade controls and what about medicines – aren’t they exempt from sanctions?

Sanctions and trade controls are limitations that target trade, financial, and other dealings with a country, person, or activity.  The subject or target of sanctions may be a foreign government or government official, all persons in a comprehensively sanctioned country or territory, or a private person.

Sanctions screening should be a critical part of a firm’s regulatory compliance framework and helps protect businesses from illegally engaging with any sanctioned companies, entities, or individuals. Medicines are exempt from sanctions, although this exemption does not apply where the end-user is a person, entity or body listed in Annex IV (COUNCIL REGULATION (EU) 2022/328 of 25 February 2022).  It is therefore essential to check if every institution, or every entity in the medicine’s supply chain, is linked to a sanctioned individual.  This check can be conducted by utilizing a screening tool, which are specialized tools organizations use to ensure compliance with various international and domestic regulatory requirements.

To what extent are patients impacted and what are the regulations?

In the real world, although medicines are exempt of sanctions, in reality US and EU sanctions have deterred international banks and firms from participating in commercial or financial transactions with these countries, thereby affecting the access to medicines (Human Rights Watch, Current Access to Medicines in Iran, 2019).

Medical Devices are also exempt from sanctions, although as with Pharmaceuticals, you need to check that the technology does not have a dual use, to ensure no parts of the medicine can be used in military applications (chemical or biological weapons).  Something as benign as mineral water, could be used for nuclear fusion, which therefore has a potential military proliferation.  In the US, the Bureau of Industry and Security (BIS), is responsible for regulating the export of most commercial items, often referred to as “dual use” items which are those having both commercial and military proliferation applications.  Most countries have clearly defined definitions and regulations regarding the exportation of dual-use items, so it is important to ensure that these regulations are adhered to and to check your product against these regulations.

Which countries are impacted?

The sanctions list is complex, and it is not one list.  US, EU, and UN sanctions are the main western ones, however, sanctions may apply against countries in the west (Chinese sanctions against the US for example).  So, it really depends on where the medicine is coming from and where it is going to, to understand which sanctions apply.

Based on US, EU and UN sanctions, Russia is now the world’s most sanctioned country, followed by Iran, Syria, and North Korea.  Cuba, Venezuela, Myanmar and even China also feature on the sanctions lists, which means that large swathes of the world’s patients are residing in sanctioned countries.

What are the requirements for delivering medicines to a sanctioned country?

Depending on which countries could be seen as part of the export, you need to comply with multiple regulations. For example, if it is a US Product, with a US company performing the trade, conducted by US employees, then an organization would need to comply with US regulations.  However, if it a US product (more than 10% US origin), with a UK company performing the trade, conducted by EU employees, then the company would have to follow US, EU, and UK regulations.

What factors that can drive a company’s approach to running an EAP in sanctioned countries?

There are numerous factors and considerations that can drive a company’s approach to running an EAP in sanctioned countries, these include:

• Company Policy – Does your company’s policies and SOPs allow for the distribution of medicines to sanctioned countries

• Logistical – Do you, or your partners, have the logistical expertise to deliver complex medicines to often hard-to-reach countries?

• Supply chain risk/leakage – How do you ensure that the medicine ends up in its intended destination, and in the hand of the intended patient?

• Political – What is the current political situation, and is the intended destination a current conflict zone?

• Financial – If you’re charging, who will invoice? Some banking entities won’t transact with certain sanctioned countries

• Demand – Where are there ‘pools’ of patients with an unmet need to access a specific medicine?  Epidemiology in certain regions can create disease ‘hot spots’ so it may be an area of high unmet need.

• Public Perception / Press – Will this be perceived positively or negatively by the media and the wider community?

• Patent Protection – Some countries have less stringent patent laws, so by importing a medicine to that country are you risking the creation of unauthorized generics

• Regulatory – What are the regulation to supply a medicine into a specific, potentially low- or middle-income country?

• Insurance policies – Does your insurance policy cover transactions into specific sanctioned countries

What are the due diligence activities needed to compliantly supply medicine into a sanctioned country?

There are various due diligence and sanction screening activities to compliantly supply medicines (Early Access or otherwise) into a sanctioned country. Here are a few to consider:

• Is your company ok with these transactions? Is your compliance department ok with the transaction?

• Does your bank agree to the transactions?

• Will the Transaction/shipment will be insured?

• Describe, in detail, the financial flow including supplier, customer, all parties involved?

• Describe, in detail, the manufacturing supply chain of the goods being shipped

• Cold chain or ambient? Not frozen? (Cryo vessels are sanctioned)

• Do you have a freight forwarder that agrees to the transport(s) to Country X?

• Is your 3PL ok with the set-up and do you have a freight forwarder that agrees to the transport(s) to Country X?

• Do you know all the stakeholders?

• Who is the end-user(s)?

• Any US origin? US content? How much (in %). Any UK origin? UK content?

What are your key, concluding remarks?

Sanctions screening is a critical part of a firm’s anti-financial crime framework and helps protect businesses from illegally engaging with any sanctioned companies, entities, or individuals.  It is particularly important to conduct proper due diligence when dealing with sanctioned countries, as the US treats sanctions list violations as a serious threat to national security and foreign relations.  Sanctions violations can incur significant fines, so it is important to approach this diligently.

Conversely, by not taking these steps you are potentially not reaching a large patient population, and they will not access innovative, perhaps life-saving and life-improving medicines.