Twenty years ago. 2004. The year the Olympics returned to their birthplace of Athens. I was also returning home to Italy to commence a new job in the biopharmaceutical sector, then and now a critical European industry.
It was also the year, in Brussels, that two directives — governing medicinal products for human use, and community procedures for the authorization of medicine products — were adopted. These directives provided the framework for medicine development since.
Such medicine development takes time. Still in 2004, at AbbVie (or Abbott at the time), scientists were persevering with test after test to turn an idea into a molecule, and to turn that molecule into a cancer medicine.
Their winding road was long, but ultimately successful, during which time this group of researchers were the first to map a new protein family. In 2006, human trials began. Ten years later, the drug was approved in Europe for a type of blood cancer.
Twenty years ago, chemotherapy dominated the treatment of these patients. It is not the case anymore.
Today, as an Italian and a European, I am proud this drug is approved, reimbursed and available to patients in my country and across the Continent, from Portugal to Poland, from Ireland to Greece. There are many such stories and Europe has made a significant contribution.
A framework for the next 20 years
However, over the last 20 years, the share of new treatments originating in Europe has fallen from 50 percent to 22 percentii. We need to consider what environment is needed for Europe to enhance its scientific power.
Today, as members of the European Parliament review the biopharmaceutical legislation perhaps for the next 20 years, I believe science gives us reasons for optimism. Here are three reasons why.
- We are developing medicines more quickly.
For people affected by disease, time is of the essence. The faster we can develop and approve new treatments, the more time we save. And science wants to move faster. At AbbVie, we’ve set ourselves the goal of accelerating the process to develop drugs in half the time.
For people affected by disease, time is of the essence. The faster we can develop and approve new treatments, the more time we save. And science wants to move faster.
We are now using advanced analytics powered by artificial intelligence to speed up the start of clinical trials, doing so 50 percent fasteriii. That’s what’s happening today. It’s tangible.
European regulatory policy has served its purpose over the past 20 years, but while industry makes the changes it can, so too can the system evolve. The legislative proposals take important steps towards modernizing the framework, such as making greater use of regulatory flexibilities and setting a target to accelerate approval timelines. This creates optimism that the EU can bring the speed of European approval to levels competitive with its counterparts in the U.S., Canada and Japan to ultimately get medicine into a patient’s hands faster.
2. European science can deliver for European patients
In Europe alone, the pharmaceutical industry spends €41.5 billion a year on research and developmentiv. At AbbVie, around 6,500 people work exclusively on research and drug manufacturing at 10 sites in six EU countries. This contributes to jobs, skills and the economy, not to mention sophisticated supply chains serving European patients.
But the strategic autonomy of the pharmaceutical sector in Europe is not limited to buildings alone. We invest in and partner with European small- and medium-sized enterprises (SMEs), which are an essential part of a dynamic European science base.
We invest in and partner with European small- and medium-sized enterprises (SMEs), which are an essential part of a dynamic European science base.
In Europe, 27 percent of approved products come from SMEsv, and collaboration with a pharmaceutical company considerably increases the chances of success. At phase III of drug development, the success rate is 63 percent with a pharmaceutical partner and 0 percent withoutvi. An AbbVie cancer medicine, the fruit of such a European collaboration, is being launched across Europe as we speak.
We need this ecosystem in Europe, and for global pharmaceutical companies to invest here. To ensure these collaborations flourish in the future we should maintain predictable and competitive intellectual property policies across Europe.
3. Treatment results are improving every year — that’s something to celebrate
Pharmaceutical legislation is vast and, yes, highly technical. But it can mean we forget about the health care advances we have made. Perhaps this is because scientific progress is incremental – we improve results through trial and error.
Take psoriasis, for example: thanks to successive waves of innovation, the number of patients with no detectable psoriasis has risen from 4.2 percent with the first biological treatment to 40 percent with current therapiesvii. Let’s take a step back and celebrate the progress. We’ve improved the quality of life for people across Europe, alleviated pain, and enabled people to stay in work and be free from the burden of their disease.
For this to continue in the future, we need to maintain a broader definition of unmet medical need, and I urge policymakers to seize opportunities to do so in legislation, as many European patient groups have called for.
For this to continue in the future, we need to maintain a broader definition of unmet medical need.
Today’s decisions; tomorrow’s medicines
Today, my role extends beyond Europe and I want European citizens to continue to have the opportunities I had to work within this sector and for patients to benefit from it.
I firmly believe we can take steps to modify our European pharmaceutical policies in a way that is sustainable, competitive and encourages medicines to be launched across the European Union rapidly.
Twenty years ago, my colleagues in AbbVie held out hope that their work would one day make it to patients. It has.
I am sure in 2004, when the previous directives were adopted, European policymakers also looked ahead to the positive impact this would have on medicine development.
We must now imagine the needs for the next 20 years.
References:
[i] Breaking the rules of science to treat cancer; AbbVie; September 2023; Available at: https://www.abbvie.com/who-we-are/our-stories/breaking-the-rules-of-science-to-treat-cancer.html#:~:text=The%20AbbVie%20team%20had%20a,brought%20more%20questions%20than%20answers. Last accessed: February 2024
[ii] The Pharmaceutical Industry in Figures; Key data 2021; Pharmaprojects & SCRIP; March 2021; as cited in Attachment to EFPIA’s response to the European Commission’s open public; EFPIA; October 2023; Available at: https://efpia.eu/media/636688/efpia-attachment-to-the-european-commission-open-public-consultation-on-the-revision-of-the-general-pharmaceutical-legislation.pdf. Last accessed: February 2024
[iii] 5 ways AbbVie is working to deliver medicines in half the time; AbbVie; November 2023; https://www.abbvie.com/who-we-are/our-stories/5-ways-abbvie-work-to-deliver-medicines-in-half-the-time.html. Last accessed: February 2024
[iv] Year referenced 2021. The Pharmaceutical Industry in Figures; Key data 2022; EFPIA; Available at: https://www.efpia.eu/media/637143/the-pharmaceutical-industry-in-figures-2022.pdf. Last accessed: February 2024
[v] Where do new medicines originate from in the EU?; Lincker et al; 2014; Available at: https://www.nature.com/articles/nrd4232. Last accessed: February 2024
[vi] Takebe T et al., Clin Transl Sci. 2018 Nov; 11(6): 597–606. Available at: https://ascpt.onlinelibrary.wiley.com/doi/full/10.1111/cts.12577. Last accessed: February 2024
[vii] Addressing unmet medical need; EFPIA; October 2023; Available at: https://efpia.eu/media/5mdnhjcq/addressing-unmet-medical-need.pdf and Armstrong, A. W. et al. Comparison of Biologics and Oral Treatments for Plaque Psoriasis: A Meta-analysis.JAMA Dermatol. 156, 258 (2020). Last accessed: February 2024
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