During the Covid‑19 pandemic, pharmaceutical companies were among those whose activities were the most affected. They have been required to make a major effort to produce personal protective equipment and to research and develop treatments and vaccines for the virus. Some companies even joined forces by creating joint ventures with the aim of carrying out joint research and development.
To facilitate market access for safe and innovative products, national regulators often introduced new, exceptional rules to which operators had to adapt quickly.
This emergency also led many actors new to the pharmaceutical industry to seek legal advice. They included those who converted their industrial production to make personal protective equipment. Another example is wholesalers involved in online distribution who marketed various emergency-related products such as masks, gloves and virus tests.
All these companies had to implement a series of procedures to balance the need of solidarity, personal profit and citizens' safety. However, some institutions set up new emergency rules; to introduce products on the Italian market according to faster and simpler procedures, for instance. But the need to guarantee the full safety of citizens never lost its priority. Hence the need to clear legal advice.
The broadest shoulders bore the heaviest burden
Pharmaceutical companies who were already on the market saw the most significant impact to their operations. They were asked put in the greatest efforts to combat the pandemic, both in terms of production and of sharing innovative products with hospitals to launch clinical trials.
In Italy, AIFA – the state agency responsible for the regulation and supervision of the pharmaceutical market alongside the Ministry of Health – introduced a series of simplified rules for access to clinical trials or compassionate use programs. The main objective was to fast track the use innovative drugs in hospitals.
Some Italian clients took advantage of these simplified measures and sought legal advice on how to initiate clinical trials or compassionate use programs on their medicines. The requirements for accessing these procedures were not changed substantially meaning that there were no particular delays in the study of new rules or regulations, other than procedural ones. Undeniably the authorities also made enormous efforts with regard to legal operators, often making themselves available to discussion and clarify the new procedural rules.
Syncing state and business
This interaction between regulators and the business community was crucial to implement the rules comprehensively and efficiently. I hope these special circumstances taught us that discussions and debates between the government and industries are essential for achieving optimal mutual solutions.
However, some issues nevertheless emerged. There was confusion regarding the labelling of products imported from outside the European Economic Area. Although the new procedures were meant to speed up clinical trials or compassionate use programmes, they did not simplify labelling for the required drugs. This risked delays because companies could not always relabel products fast enough.
Marketing pharmaceuticals to healthcare professionals also presented legal dilemmas. Certain promotional campaigns from wholesalers were based on recent publications from scientists around the world who were searching for suitable virus treatments. However, the authorities in charge of approving advertising material before its dissemination maintained a rather restrictive attitude. The health authorities insisted on carefully monitoring all scientific information to avoid misleading doctors or sending them contradictory messages.
Learning to balance profit with public interest
However, this caution must be assessed in relation to businesses’ needs to exploit the opportunities (regretfully) created by the pandemic. Pharmaceutical manufacturers and distributors may benefit from highlighting that, according to the scientific literature, a particular product or active ingredient can have a beneficial effect on patients.
Yet here the authorities seemed to maintain a lenient attitude to sanctions. In most cases where a clamp down was deemed necessary advertising materials were merely prohibited, without the use of fines.
All in all, the pandemic seems, so far, to confirm the pharmaceutical industry’s central role in the state’s public health strategy, especially in emergencies. Studying new solutions inevitably involves dialogue between pharmaceutical industry associations and national regulatory agency representatives. This dialogue must focus on a careful evaluation of the interests at stake to strike the right balance between profits and the maximal protection of citizens' health.
Laura Opilio is head of the Dispute Resolution Department and Insurance & Funds practice at CMS, Rome, Italy.