The pharmaceutical industry is an ever-growing and expanding market. As the value of the European pharmaceutical market has more than doubled in the last two decades, medicine has become increasingly unaffordable and unavailable for patients. Considering that the research and development of medicine are mostly publicly funded, the EU has a large interest in this development due to their investments. Unfortunately, the influence of the pharmaceutical industry has grown exponentially as well and has led to EU legislation that favours the financialisation of the pharmaceutical market.

The rising prices and inaccessibility of medicine have led to a clear dichotomy between viewing people in need of treatment as clients instead of patients. Patents and strong intellectual property laws have emphasised this dichotomy, leading to extended patenting and increased monopoly pricing. As patents are originally designed to serve as a financial incentive for the production of medicine, an argument can be made that patenting can lead to increased innovation. Since the pharmaceutical industry is one of the most important European industries, it can be debated as well whether the current pricing represents the true, and fair, cost of a healthy life.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) is the largest and most influential lobbying group for pharmaceutical companies in Europe. EFPIA spends well over EUR 6 million on their campaigns annually, which has led to 112 top-level meetings between EU officials and representatives of Big Pharma with the Juncker-administration of the European Commission alone. As the main lobbying body for the pharmaceutical industry, EFPIA’s interests lie in strong patent laws and increased profits. This lobbying organisation is incredibly influential in European decision-making surrounding the pharmaceutical industry and has had a hand in most major legislation regarding the sector, like the renewed SPC regulations, the Pharmaceutical Strategy for Europe and regulations in the Health Technology Assessments of medicine.

The European Medicines Agency (EMA) is the body in the EU-centralised approach towards pharmaceutical production that regulates, assesses and approves medicine before it can be produced and distributed, after which the European Commission takes a final stance on the approval. EMA is largely funded, for 90% of its budget, by pharmaceutical companies, which causes a major corporate influence in their decisions. It has been found that EMA has approved drugs with low or uncertain therapeutic value, which calls the independence of the body into question.

Although pharmaceutical pricing is a national competence, the European Network for Health Technology Assessment (EUNetHTA) has been established as the framework for managing the Health Technology Assessment (HTA) bodies. These bodies assess and decide on the therapeutic value of a drug. It communicates the decided upon price, based on the therapeutic value, to the national governments.

Medicines for Europe is the largest representative body of the generics industry in Europe, supplying almost two-thirds of all European medicine. SPCs and evergreening fundamentally impact the generics industry, as the production of biosimilars is not able to start until a patent has completely expired.

Médecins Sans Frontières (MSF), or Doctors Without Borders, is one of the largest non-governmental organisations (NGOs) promoting equal healthcare, with healthcare workers and health initiatives all over the globe. They represent the interests of patients and are a loud voice in the conversation surrounding a fair and sustainable healthcare system.

The Pharmaceutical Strategy for Europe, which was adopted in November 2020 by the European Commission, highlights the four main objectives of the EU in order to ensure access to safe and innovative medicine. These four objectives are access to affordable medicine, supporting competition and innovation, enhancing crisis management, and ensuring a strong EU presence in the pharmaceutical market. The entire Strategy mentions very little about the increasing influence of the pharmaceutical industry and the detrimental effects that this has on the lives of patients, and instead focuses on the role of national governments in the pricing and distribution of medicine.

The European Patent Convention is the main legislative framework for all patents in Europe. This legal framework is carried out by the European Patent Office (EPO). They are responsible for all patents and secondary or extended patents across the continent. It currently has 38 members, including all Member States.

The EU-wide Regulation on Health Technology Assessment (HTA) is meant to regulate the existing HTA bodies by providing a framework by which they can operate in a centralised manner, which will lead to fairer pricing and fewer discrepancies between countries. The main goal of this regulation is to reduce duplication between national governments and to lay down rules about involvement in clinical assessments. This regulation has largely replaced the Joint Actions EUNetHTA.

The use of evergreening, which is the prolonging of patents through the invention of ‘new medicine’ that has actually been just slightly modified without improving the therapeutic value, has impacted the lives of patients for decades. As no European legal definition or legislation exists around the topic of evergreening, this way of extended patenting is commonly abused.

Another type of extended patenting is the usage of supplementary protection certificates (SPCs). These prolong an already existing patent by five years, commonly by slightly tweaking the formula through long laboratory processes, which increases pricing and is enough to qualify for an SPC. Through these practises, pharmaceutical companies try to maximise their profits by not letting go of monopoly pricing. SPCs are a factor that leads to a stagnation of production in the generics industry, as they prolong patenting that prevent biosimilar companies from producing.

The COVID-19 pandemic has highlighted the inequality in global medicinal distribution. Although COVAX and the European Commission promised equal distribution of vaccines across the world, strict IP laws and ‘hoarding’ of vaccines by Western countries have led to what some leaders call ‘vaccine apartheid’. Despite promises of a waiver of IP rights for COVID-19 vaccines, this has not yet been made a reality, due to the lobby of Member States with strong ties to the pharmaceutical market.

Other regulations, like financial incentives that encourage the development of medicine for rare diseases (so-called orphan drugs), are commonly abused in order to gain extra profit. Two major problems surround this way of playing the system. Firstly, research and development (R&D) budget is given to the now more profitable orphan drug research, while the larger needs of common illnesses are neglected. Additionally, the exorbitantly high prices of these orphan drugs lead to inaccessibility for the patients who do need these treatments.

The extensive lobbying of EFPIA perfectly shows the far-reaching influence of Big Pharma on European decision-making. Large campaigns in Brussels, with messages like “without incentives, innovations stop”, and many conversations between lobbyists and EU officials have created a free reign for pharmaceutical companies to align the EU’s decisions with their interests. This connects to the financialisation of the pharmaceutical sector: the increased value of the industry and increased investments in financial strategies have led to an industry that is more interested in the profits of its shareholders than the lives of its patients.

Following decades of rising prices in relation to extended patenting and intellectual property rights, concerns have been raised about the effectiveness of patents in increasing competition and innovation. The pharmaceutical industry is a complicated market, with many viewpoints to consider. Although incentive for the production of life-saving medicine is needed, abuse of monopoly pricing, patenting systems, and therapeutic value mechanisms runs rampant in that very same industry. Because of the current global COVID-19 pandemic, accessibility and affordability of medicine are needed now more than ever.

• How, if at all, should the EU create a balance between economic growth in the pharmaceutical industry and medical innovation?
• What is the role of patents in accessibility and affordability of medicine?
• What role does lobbying play in the decision-making process in regards to pharmaceutical pricing and the determining of therapeutic value?
• Does, or should, economic interest lead to innovation?
• How can the EU prevent the forming of a shared monopoly in the pharmaceutical market?
• How has the privatisation of national healthcare systems, in countries like the Netherlands, affected the accessibility of medicine?