Amélie Robine, lawyer: “The MEDISAFE project offers a comprehensive approach to combating counterfeit medicines”

Why focus on the legal aspect of medicines?

Amélie Robine – A drug is not a product like any other: its sale must be regulated for reasons of public health and safety. The current health crisis clearly illustrates this. For example, in late March 2020, the World Health Organization warned against the “growing number of falsified medical products that claim to prevent, detect, treat or cure COVID-19” and their potential side effects.
 

A drug is not a product like any other

This trend has been confirmed by Europol, the European police agency: again in late March, it announced that Operation Pangea had led to the seizure of 4.4 million counterfeit medicines and the arrest of 121 people linked to organised crime groups.

How to fight against counterfeit medicines?

Amélie Robine – You have to focus on both the preventive and repressive components. Pharmaceutical regulations come into play upstream: the stronger they are, the more a country will be able to ensure that the medicines marketed are quality medicines. A public body – the National Agency for the Safety of Medicines and Health Products (ANSM) in France – is responsible for authorising the placing on the market: it checks that the product complies with applicable standards, decides who can dispense it… Once the product has been marketed, this body’s role is to monitor the side effects and it may have to decide to withdraw a product deemed to be unsafe.

On the downstream side there is criminal law. It includes offences in the event of non-compliance with pharmaceutical regulations. This can involve trafficking in medicines or marketing a drug that is not authorised or contains the wrong active principles. Criminal law aims to be both repressive and dissuasive through strong sanctions (fines or prison sentences).
 

Strike this balance between pharmaceutical regulations and criminal law

To function well, a health system needs to strike this balance between pharmaceutical regulations and criminal law, which is not the case in all countries. The originality of MEDISAFE lies in the fact that it combines these two components in an overall approach to the issue: in addition to strengthening pharmaceutical regulations, it addresses the issue of the safety of medicines, paying special attention to criminal law.

What is the situation in MEDISAFE’s partner countries in Central and East Africa?

Amélie Robine – Missions conducted under the MEDISAFE project have allowed us to meet our counterparts and assess the legislative and legal framework. The analysis of the data collected shows that Central and East African countries must work on both the regulatory and criminal components.
 

Pharmaceutical regulations are more or less developed depending on the country

Pharmaceutical regulations are more or less developed depending on the country. Kenya, Ghana and Ethiopia already have strong measures, but regulations are more in their infancy and need to be strengthened in other countries in the region. The other difficulty is the lack of specific criminal legislation for medicines in general and counterfeit medicines in particular (manufacturing, transport, sale…). Under criminal law, to be able to prosecute, the reprehensible conduct must be provided for by law. Even if it is always possible to use general provisions – for example, the prohibition on document counterfeiting – it is useful to have targeted legislation as a deterrent. Furthermore, there must be exemplary sanctions, yet they are often weak in this region, for both fines and prison sentences. Consequently, trafficking in counterfeit medicines is today very lucrative with little risk to traffickers.

Have initiatives already been taken?

Amélie Robine – The situations and issues differ depending on the country – a big country with many neighbours like the Democratic Republic of Congo faces more challenges than Malawi –, but counterfeit medicines kill people everywhere, so African countries are taking up this issue.
 

Several of them have signed the MEDICRIME Convention

Several of them have recently signed the MEDICRIME Convention, a binding legal instrument that aims to harmonise the definition of criminal offences in the field of counterfeit medicines and provide signatory States with tools to fight against this problem in a more effective and coordinated way.

The other development is the creation of the African Medicines Agency, the treaty for which has been signed and is in the process of being ratified. It includes a “model law” proposed by the African Medicines Regulatory Harmonisation (AMRH) Programme housed at NEPAD. This model law aims to facilitate the harmonisation of pharmaceutical policies and regulations in Africa. This harmonisation is crucial, as trafficking in counterfeit medicines is largely transnational. Consequently, if all countries have the same basis, this will subsequently facilitate controls and limit the entry of medicines that are not compliant with the defined criteria.

What are the other possible ways of coming up with effective regulations and oversight for the pharmaceutical market?

Amélie Robine – In addition to the development of appropriate legislation, it is necessary to take action at several levels and this requires mobilising everyone, from the patient to the legislator.
 

This requires mobilising everyone, from the patient to the legislator

This firstly requires improving knowledge of legislation: the authorities responsible for market surveillance need to know the laws that can be used to fight against counterfeit medicines. They need to benefit from training for this.

It is also necessary to develop coordination between stakeholders, as the fight against counterfeit medicines is multidisciplinary. Some countries set up interdepartmental units (health authorities, foreign affairs, customs, police…). It is also useful to set up specialised units at border posts to carry out targeted controls and pass on information if a suspicious batch is identified. This requires implementing processes to organise this reporting and ensure it reaches the right people.

How is it taken into account in the MEDISAFE project?

Amélie Robine – MEDISAFE offers a comprehensive approach to fight against counterfeit or substandard medicines, based on three pillars: prevention, detection and response.

We propose activities tailored to needs, based on the initial diagnostics and our exchanges with the stakeholders in each country. For example, to strengthen the legal framework, we offer assistance to countries that are conducting a legislative reform in the field of medicines (legal definition of medicines, link with the MEDICRIME Convention…). For instance, between July and September 2020, we organised webinars on the possible legal responses to fight against trafficking in counterfeit medicines related to the Covid-19 crisis – until we are able to resume the on-site technical assistance.

This legal assistance is coordinated with the other project components: technical capacity building for our partners via training (detection of counterfeit medicines, etc.), development of interdepartmental cooperation, promotion of regional and international cooperation and, finally, awareness-raising work at all levels – administrations, health and legal professions, general public.

 

 

Amélie Robine holds a Ph.D. in Law and is a lawyer at the Paris Bar. She works as a legal expert for the MEDISAFE project, which is financed by the European Union and implemented by a consortium led by Expertise France. This regional project is helping 11 East and Central African countries (Burundi, Democratic Republic of Congo, Ethiopia, Ghana, Kenya, Malawi, Rwanda, Seychelles, Tanzania, Uganda and Zambia) strengthen their prevention, detection and response mechanisms against substandard or counterfeit medicines.