On April 26, the European Commission presented a pharmaceutical regulation reform proposal, a law that has not been touched for 20 years. The package, which had been brewing since 2020, bears the imprint of the pandemic trauma. covid-19 revealed cracks on the walls of the European pharmacy: dependence on foreigners for manufacturing, opaque contracts with pharmaceutical companies, high drug costs, etc. Faced with these challenges, the Commission has (timidly) opened the melon of the pharmaceutical business.
Now, the regulation will go to Parliament and the Council. For it to be approved before the 2024 European elections, it is crucial that Spain prioritize it in his semester of European presidency, in the second half of 2023. If it were not approved on time, it could be in a toast to the sun Last week, various organizations sent a letter to the health minister asking for that prioritization. Ministry sources affirm that “the pharmaceutical package will advance during the Spanish presidency of the EU, although it is materially impossible for it to end in six months& rdquor ;. These are the keys to the proposal.
Deadlines for new drugs
The time for evaluation and authorization of a new drug decreases from 400 to 180 days, thanks to a simplification in the structure of the European Medicines Agency (EMA). It establishes a critical drugs list, which companies must guarantee by reorganizing their production and generating stocks. “There is an intention of the Commission to strengthen pharmaceutical production in Europe, after years of relocation& rdquor ;, he explains James Vidal, Policy Advisor to Health Action International (HAI). However, there is no commitment to public production. “That would establish competition that would limit price abuse by companies,” he notes. Juan Jose Rodriguez Sendinpresident of the Fair Access to Medicines Association (AAJM).
Covid-19 vaccines were created thanks to decades of public research and advance purchases by states. The Commission proposes that companies publish the public investment in clinical trials. “We do not disagree, but it is very difficult to allocate shared costs,” he says Iciar Sainz from Madrid, director of the international department of Farmaindustria. “It is a first step, but this data does not include the value of the work of public investigators, nor tax exemptions & rdquor ;, observes Vidal. “Nor is it obliged to disclose the company’s actual research and development costs: that information would be essential to negotiate fair prices,” he observes. Ellen’t Hoen, expert lawyer in intellectual property. In addition to research, the price of drugs is also influenced by marketing and the high margins of pharmaceutical companies.
Lift patents in case of emergency
One is created european compulsory license, that is, a system that allows the widespread production of medicines even when the monopoly of the inventing company is in force. This ‘Red button’ it could be tightened only in the event of a public health crisis, such as a pandemic. “We are against the lifting of patents. During the pandemic, the industry has responded in an exemplary way and it has supplied the world market without a compulsory license& rdquor ;, says Sainz from Madrid. For the other sources, on the contrary, the measure falls short, because it does not allow suspending the protection in other cases: for example, if the company abuses its dominant position to impose an inflated price.
encourage antibiotics
Bacteria resistant to antibiotics portend a health crisis on the scale of the pandemic. The Commission aims for a “market failure & rdquor;: No company wants to produce new antibiotics at a time when it is imperative to reduce their use. To correct it, the transferable exclusivity bonds. If a pharmacist produces a new antibiotic, they are compensated with a bonus. With it, the company can increase the monopoly time in the production of another drug of its own. Or you can sell the voucher to another pharmacist. “The idea is good, but the conditions are so restrictive that it will not be effective& rdquor ;, says Sainz from Madrid. “It does not seem to me the best way to encourage the development of antibiotics. It would be better finance it directlygiving a role to HERA [dirección general dedicada a las emergencias sanitarias creada en 2021]”, says ‘t Hoen.
Less time for generics
The Commission dares to touch the heart of the pharmaceutical business: the monopoly in the production of new medicines that allows them to recover investments and make profits. This is achieved with patents and with the data and market exclusivity: this last mechanism prevents in practice that a generic of a certain drug can be marketed for a few years. In its proposal, the Commission cuts this protection from the current 10 years to 8. That allows the generic enter a little earlier and give a break to public coffers, increasingly aggrieved by the exorbitant costs of innovative drugs.
“This approach worries us and many. It is a notice to the investment funds that it is going to protect innovation less& rdquor ;, says Sainz from Madrid. “The Commission touches on some interests of the pharmaceutical companies, but seeks make up for with other incentives, such as transferable vouchers & rdquor ;, says Vidal. This expert regrets that the concept of affordability of the drugs, which was in the first drafts, has disappeared. “You cannot pay exorbitant figures and leave a public service in the hands of the industry. There is some concern in European spaces to modulate this situation. They seek to give an apparent answer. But no substantial changes& rdquor ;, concludes Rodríguez Sendín.