The European Union's latest struggle to regulate and democratize the pharmaceutical market has exposed again the huge power of influence acquired by the big companies.
In April 2023, the European Commission launched the legislative process for the first major overhaul of the bloc's medicines regulations in 20 years. The legislative package aims to make access to medicines more secure and affordable, encourage innovation, and reduce red tape. It touches on everything from medicines access to drug shortages and the bloc's pharma regulator, according to an analysis by Politico.
The European Parliament and the Council of the EU must reach a negotiating position on the Commission's texts and then hash out a compromise agreement on each of the laws before they can finally be voted through. Given the size and political sensitivity of the package, it's unlikely this will be done before European Parliament elections in 2024.
Therefore, the legislative process is still in its initial stages. But the slow ride is due not only to the complexity of the package but mainly to the attempts of the Big Pharma influence groups to keep their profits secure.
Cutting the perks and broadening access
The most critical change pushed by the EU Commission is cutting the perks that drugmakers enjoy to let unbranded rivals enter the market earlier, driving down consumer prices. It proposes slashing the time pharmaceutical companies sell their medicines without competition. Currently, companies that develop branded medicines have ten years to sell a new drug unchallenged, after which rivals can launch unbranded "copycat" drugs that quickly drive down prices — and profits.
The problem is that the EU single market does not function when it comes to life-saving medicines. Patients across the bloc don't have the same drugs available when battling disease. On average, a doctor in Romania or Poland waits two years to prescribe the same cutting-edge medication as their counterpart in Germany. If someone suffers from a life-threatening illness such as cancer, that's the difference between life and death.
"Patients in Western and bigger member states have access to 90 percent of newly approved medicines. This number is as low as 10 percent in Eastern and smaller member states. This is truly unacceptable," said Health Commissioner Stella Kyriakides in her speech in April.
The Commission's idea is to punish companies that don't launch their product in the EU's 27 markets within two years. If they don't play ball, they will face earlier rival competition.
Big Pharma's threats
As legislators in the EU Parliament begin their long wrangling over the details of the text, the lobby groups go full steam. On 3 October, The European Federation of Pharmaceutical Industries and Associations (EFPIA) published its official response to the draft Pharmaceutical Legislation, claiming that the proposals "would harm patient access to medicines and innovation" and asking the European Parliament to "take the opportunity to amend the legislation so that it can foster the development of new treatments."
Lower profits will mean fewer new treatments, EPIA says through the lines. And to make things clear, EFPIA comes up with the "my way or the highway" type of argument:
" The sweeping consensus from innovators and investors - those who develop new medicines and vaccines in Europe - is that the cumulative impact of the proposals would lead to companies, both large and small, carrying out research and development outside of Europe. The reduction - by a quarter - of Europe's regulatory data protection (RDP) for innovations, and the addition of complex and unattainable targets for companies to recover that – will undermine competitiveness. It will accelerate a trend in the region - which has already lost a quarter of its R&D investment to countries like the USA and China over the past two decades."
EFPIA represents the biopharmaceutical industry in Europe and includes 37 national associations, 38 leading pharmaceutical companies, and a group of SMEs.
A hold-up on Social Security
A report published in January 2023 by two health NGOs claimed that the pharmaceutical industry disproportionately influenced EU institutions, harming public health, particularly during the COVID-19 pandemic.
The pharmaceutical lobby's influence on EU institutions like the European Commission and the Parliament increased significantly during the COVID-19 pandemic – a trend that also impacted the health of citizens, according to the Global Health Advocates (GHA) and StopAids report. "Private interests exerted an inordinate amount of influence on European decision-makers during the pandemic, resulting in a lack of transparency on publicly-funded vaccine contracts," Rowan Dunn, EU advocacy coordinator at GHA, told EURACTIV France in an interview.
At the start of the COVID-19 pandemic in March 2020, the European Commission sought to provide EU countries with vaccine doses as quickly as possible. In June 2020, the Commission concluded contracts with pharmaceutical companies to deliver COVID-19 vaccine doses to member states.
Known as the European Vaccine Strategy, these bulk vaccine purchases have helped speed up the manufacture of doses and ensure equitable access to vaccination for all citizens across the bloc. While most doses were purchased from Pfizer, vaccines produced by Moderna, AstraZeneca, Janssen, Novavax, and Valneva also received the green light from the European Medicines Agency.
By the end of July 2020, the first doses were being administered, and by July 2021, 70% of adults in the EU had received at least one dose of the vaccine. But, according to the report, the Commission, faced with the vaccine emergency, gave in to specific demands from pharmaceutical laboratories, including pricing, the transparency of contracts, and intellectual property.
"The advantage of intellectual property is that pharmaceutical companies have a monopoly and can therefore make a maximum profit," Belgian MEP Marc Botenga, a member of the European Parliament's Special Committee on the COVID-19 pandemic, said. "By giving pharmaceutical laboratories control over the price of doses thanks to intellectual property, there has been a hold-up on our social security," he added.
To highlight how influential the pharmaceutical lobby is, the report refers to the vaccine purchase contracts between US pharmaceutical giant Pfizer and the European Commission, which have been at the heart of the recent controversy.
Text messages allegedly exchanged between European Commission President Ursula von der Leyen and Pfizer CEO Albert Bourla over a contract relating to the purchase of 1.8 billion doses of COVID-19 vaccines have caused quite a stir. The European Parliament, NGOs, and the EU Ombudsman are calling for these redacted and thus unreadable documents to be made public.
Faced with numerous questions from EU lawmakers, pharmaceutical giant Pfizer remained vague about the opacity of its vaccine purchase contracts and the text messages exchanged with Ursula von der Leyen.
Despite the relatively successful vaccination campaign in the EU, the pandemic has highlighted the very strong influence of pharmaceutical companies on public authorities. To increase transparency and limit this lobbying, StopAids and GHA recommend that future negotiations between the Commission and pharmaceutical companies be conducted "fully open and transparent" and use "established processes rather than informal channels."
A research group Corporate Europe Observatory report in 2021 showed that, according to data aggregated from the EU's Transparency Register, pharmaceutical corporations spend at least €36 million annually to influence EU decision-making, either directly or through lobby consultancies.
The latest data compiled by Lobbyfacts.eu shows that EFPIA spends more than €5.5 million annually, involving 34 lobbyists.
