As you may know, I am the shadow rapporteur for the LEFT group on the ENVI Committee opinion on a Pharmaceutical Strategy for Europe. I was also the shadow rapporteur on the report on the shortage of medicines and, more recently, on the report on EU options for improving access to medicines.
In the time that has passed since my colleagues and I drafted that report - in the second half of 2016 - little has changed for the better. In fact, the overall situation has deteriorated. However, the current COVID-19 pandemic is certainly not to blame; the problem goes back much further than that.
The EU’s patent law, which hampers innovation and access to medicines, has not changed in the past five years. Access to drugs for cancer or rare diseases in some poorer Member States continues to deteriorate, due to their parallel export to richer EU countries.
“Access to drugs for cancer or rare diseases in some poorer Member States continues to deteriorate, due to their parallel export to richer EU countries”
In the meantime, the unresolved problem has deepened, as healthcare systems in some countries, such as Germany or Denmark, have begun to build on their savings of parallel imports. In last 10 years, Germany has doubled the market share of parallel imported drugs.
Meanwhile in Denmark, these drugs make up more than a quarter of the entire market. This situation becomes more of a paradox when you understand that generic drug manufacturers are currently subject to stricter rules than parallel traders when it comes to the repackaging, distribution and responsibility for the quality of products.
Regarding issues of access, EU Member States face shortages of COVID-19 drugs, vaccines and other medical devices required for the vaccination campaign.
However, the issue of these shortages is not new; it has blighted the EU for decades. This pandemic has shown the true depth of the problem, highlighting the extent to which pharmaceutical companies limit access to lifesaving medicines and profit from the public health crisis, while benefiting from billions of euros in public subsidies without having to forgo their intellectual property rights.
Medicines and medical devices are not consumer goods, and patients’ lives cannot be measured in purely economic terms. Both are an essential public good and a core element of health policy. The historic reasons that underpin the EU’s generous data and market exclusivity system are no longer valid, particularly not in a post-COVID-19 world.
The idea of ‘sufficient’ profit should guide policymakers, with ‘sufficiency’ estimates driven by transparency of cost and pricing. The flexibilities inherent in patent law should not be rendered ineffective by exclusive rights granted through the medicines regulatory system.
The EU must finally find the right approach towards ‘evergreening’, ‘patent thickets’ and ‘defensive patenting’. The transparency of the entire system must be improved, including transparency of research, registration and publication of all clinical trials, as well as that of financial and other links between the industry and public institutions, healthcare professionals, academic researchers and non-governmental organisations.
“This pandemic has shown the true depth of the problem, highlighting the extent to which pharmaceutical companies limit access to lifesaving medicines and profit from the public health crisis”
The EU market is distorted and – worse still - individual healthcare systems are fragmented and do not cooperate with each other. This suits ‘big pharma’ nicely, having learned to work very efficiently in this system. So, what should the EU’s Pharmaceutical Strategy include? For me, the completely unsatisfactory patent protection law should be completely redesigned. Furthermore, we should have a permanent system for purchase of innovative medicines for cancer and rare diseases at European level.
Here, we can draw on the positive experience we have gleaned from pandemic purchases through Advanced Purchase Agreements (APAs) and Joint Procurement Agreements (JPAs). The issue of medicine shortages, particularly those caused by parallel exports, must also be urgently addressed. We cannot make the same mistake that we did five years ago.
Personally, I support the return of strategic companies producing medicines and medical devices to the EU. However, in this case it is not clear how such returns will be financed. And herein lies a particularly sore spot for the entire Pharmaceutical Strategy - a lack of funding. The idea that half of the Strategy’s priorities would be funded by the EU4health programme is completely absurd.
The total budget of this programme was eventually 60 percent of the original proposal. It needs to cover priorities such as the development of the ECDC, the EMA, supporting the WHO and arranging the stockpiling and financing of the European Union’s entire Beating Cancer Plan.