E-commerce of medicinal products: global freedom or national restrictions?

Renata Fialho de Oliveira
Veirano Advogados, São Paulo
renata.oliveira@veirano.com.br  

Beatriz Gonçalves Marconi
Veirano Advogados, São Paulo
beatriz.marconi@veirano.com.br

Introduction

The international trade of goods involves sellers and buyers situated in different jurisdictions, requiring them to deal with several aspects, such as taxation, customs, licences and administrative matters, to import and export their products in and to different territories. It contrasts with purely domestic trade, in which sellers and buyers operate within the same country and are subject exclusively to domestic legislation.

The rise of online purchase platforms has significantly increased the volume of the international trade of goods because it has become easier to find and buy goods originating from different countries, with a variety of price ranges, quality and range of choices. This scenario also applies to medical products.

On the one hand, international trade offers several advantages, such as: (1) a more competitive environment; (2) access to new products and technology; and (3) more demand for suppliers, and consequently, increase of productivity. It should be mentioned that the advantages extend to the countries involved, which can benefit, for instance, from: (1) an increase of monetary flow between countries; (2) the expansion of the consumer market; and (3) access to a greater variety of goods through the offering of imported products, for example. On the other hand, when a company decides to operate internationally, it must overcome challenges of different sorts, such as language restrictions, customs and sanitary requirements, currency and legislation.

When it comes to medical products, the challenges are even more complex, considering that the sector is highly regulated and that, in general, each country has its own rules and standards, with no international harmonisation of rules.

Challenges to global freedom in the e-commercialisation of medical products

Those that defend global freedom for the commercialisation of medical products argue that open and interconnected e-commerce for medical products can enhance access to a wider range of drugs. Consumers could potentially benefit from competitive pricing and a broader variety of medical products. Additionally, online platforms can ease patients' access to information.

However, there are several barriers for such global freedom to become an established reality. The most obvious is the highly distinguished regulatory standards and requirements for medical products adopted by each country. As a rule, they are provided for by national regulators as a means to safeguard public health by ensuring that products available in a given country comply with the safety, efficacy and quality standards set forth in the respective domestic regulation.

In view of this, the first challenge worth mentioning when one deals with global freedom in the commercialisation of medical products through digital platforms is reconciling the differing regulatory landscapes. Harmonising global standards for e-commerce for medical products is not a simple task, considering the various factors influencing regulatory decisions.

It should be noted that obstacles regarding the regulatory landscape are not restricted to rules for the registration of the medical product in the destination country. The issue starts even before marketing authorisations are obtained because, even at the clinical trial stage, there is huge variability between criterion acceptance among different countries. Ensuring consistency in trial protocols while accommodating regional differences remains a complex task.

In addition, safeguarding intellectual property rights may also present issues. Protecting intellectual property rights is a crucial aspect of commercialising medical products. Differing patent laws and enforcement mechanisms across countries can pose challenges for companies regarding shielding their innovations globally.

Furthermore, ethical standards concerning healthcare and medicine can differ significantly in different jurisdictions. Conducting business in a manner that respects local customs and values while adhering to global ethical standards is essential, but requires substantial adherence efforts.

The same applies to post-marketing actions because surveillance and compliance rules may also vary from one country to another, and can represent difficulties in ensuring a consistent and timely response to any adverse event, which is a crucial task for guaranteeing the safety and efficacy of medical products and maintaining public trust.

Thus, there are several challenges to overcome, which require collaboration and coordination among governments, regulatory bodies, industry stakeholders and advocacy groups.

Concerns that global freedom in the e-commercialisation of medical products may raise

Global freedom in the commercialisation of medical products through digital platforms also presents a long list of issues regarding guaranteeing quality and efficacy, counterfeits, unauthorised sales and the potential for misuse.

For example, the possibility that these platforms can create a profile without the need for specific registration and/or identity verification can serve as a facilitating element for the distribution of counterfeit products to massive consumer bases, and can even motivate the widespread use of these platforms by this type of offender and for such purposes.

Moreover, these platforms often become instruments for the illicit sale and distribution of medical products, including prescription drugs, circumventing the necessary oversight and violating regulatory requirements, thereby jeopardising patient safety.

Beyond the immediate risks posed to consumers, a broader challenge exists concerning national sovereignty. Nations are hesitant to give up their regulatory autonomy and reluctant to adopt foreign standards as the definitive criteria for product marketing. This objection results from the significant divergence in regulatory standards among global agencies, the complexity of harmonising the rules and the need for cooperative efforts.

E-commerce of drugs in Brazil

In Brazil, the sale of medical products, including drugs, is subject to strict regulations to ensure the safety and efficacy of these products. The National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária or 'ANVISA') is the regulatory authority responsible for overseeing and regulating the health sector.                     

According to regulations, especially ANVISA's Resolution No 44/2009, the sale of medicine through remote means (ie, phone, fax and internet) can only be carried out by pharmacies open to the public, with a responsible pharmacist present throughout operating hours. Additionally, pharmacies must provide a direct communication channel with the pharmacist for consumers to clarify their questions on medication and prescriptions. Drugs sold by pharmacies must be registered with ANVISA, and when applicable, their prices must be approved by the Drugs Market Regulation Chamber (Câmara de Regulação do Mercado de Medicamentos or 'CMED').

Various restrictions are imposed on the digital marketing of drugs; for example, there is a prohibition on displaying images of medication on the main pages of e-commerce websites.

Furthermore, the online sale of medication subject to special control is prohibited. Only last year, ANVISA definitively authorised the home delivery of medication subject to special control; however, to that effect, the pharmacy or drugstore should obtain the prescription at the address of the patient or receive it electronically. This method ensures that the sale of the drug is regular.

Note that this restriction may be reviewed by ANVISA in the coming years, considering that the review of the control and monitoring of drugs subject to special control is a topic under discussion according to ANVISA's 2024–2025 Regulatory Agenda (Matter No 1.3).

Despite the restrictions in the commercialisation of drugs through electronic means, there are initiatives aimed at fostering global accessibility to drugs. These initiatives go beyond merely facilitating the remote delivery of controlled substances, which was primarily motivated by challenges posed by the Covid-19 pandemic. One such initiative is ANVISA's Resolution No 289/2024, which delineates criteria for an optimised analysis procedure in which assessments carried out by an Equivalent Foreign Regulatory Authority may be used to analyse registration and post-registration petitions for medicine, biological products and vaccines, and a letter of suitability for the Pharmaceutical Input Dossier in the Brazilian territory.

Around the world, we find the same situation: countries with strict regulations regarding the commercialisation of drugs by electronic means, each with its own particularities, which take into account the political, cultural and social aspects of that particular country, but trying to find ways to break barriers without putting consumers in danger. Recently, for instance, the Court of Justice of the European Union (CJEU) decided that companies lacking authorisation to sell over-the-counter (OTC) medicinal products directly to the public can facilitate connections between customers and pharmacies, provided they do not engage in the actual sale of medicine itself. This marks a significant step towards relaxing rules concerning the e-commerce of medicinal products within the EU. ^[1]

Conclusion

It is undeniable that striking a balance between the free flow of goods and the need for regulatory oversight requires international collaboration, robust technological solutions and a commitment to protecting public health. Consequently, international trade agreements play a key role in allowing and making the international trade of medical products possible.

However, whether countries are willing to negotiate and remove barriers for the free flow of medical products should also be considered. After all, despite the undeniable advantages, there is a very complex and long pathway to global freedom, which involves the commitment of governments.

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