Vaccines in times of pandemic

Legal aspects

The panel dedicated to the legal aspects included three excellent speakers, all of whom are experts in pharmaceutical law.

Kiko Carrión García de Parada, lawyer and partner at the international law firm Eversheds Sutherland, told us about safeguards at the vaccine development stage and the accountability associated with vaccinating everyone in the chain. However, he made it clear that an adverse effect is not the same as a suspected adverse effect, and that a causal relationship and a detailed scientific and pharmacological study are necessary, not a mere coincidence or a routine occurrence. He detailed the possible adverse effects that could occur and stressed the importance of the principle of patient protection and indemnity. It is an excellent accountability framework.

Paulino Fajardo Martos, partner at Herbert Smith Freehills spoke about the types of liability and the extremely stringent liability system that applies to the field of medicinal products and vaccines. He explained the redress mechanisms for possible damages, focusing on no-fault compensation schemes, which protect injured parties with an effective management system without the need for lengthy litigation and provide an excellent opportunity for public-private collaboration in the face of any claims. This ensures there is a good risk/redress system balance.

He provided an interesting comparative law analysis of these no-fault compensation schemes, exploring the various models followed by different countries and highlighting aspects such as who finances these funds, how to file these claims and for what amount.

Most European countries already have these no-fault compensation schemes and Spain should consider them since it has necessary legal mechanisms.

Jordi Faus Santasusana, partner at Faus & Moliner, gave an interesting presentation on marketing authorisations, which serve to accredit the degree of safety that we should legitimately expect from a product and are based exclusively on health considerations.

He told us that the regulations also allow the possibility of providing medicinal products without marketing authorisation, as is the case with compassionate use for special requirements, an emergency scenario that allows a temporary use authorisation. This is not the case for the current vaccines but the COVID-19 vaccines have received conditional marketing authorisation. This is nothing new, having existed for years (more than 30 conditional marketing authorisations were granted between 2006-2016, of which only 2 were withdrawn for commercial reasons), and it is used for unmet medical needs and in cases where the benefit of immediate availability outweighs the risk of additional data requirements. These authorisations are subject to significant batch control and pharmacovigilance conditions.

He acknowledged the information and transparency efforts made by regulatory authorities, but also the confidentiality of commercial conditions, which is intrinsically necessary to protect public interests. Overall vaccine cost figures are transparent, without the need for access to the unit prices of commercial agreements, which would undermine the authorities’ bargaining power.