The adherence of the pharmaceutical industry to the goals of sustainable development must also be planned and then evaluated in accordance with specific and peculiar characteristics of this production area. In fact, the ambition to govern the production cycle by leaving the next generations with quantities of total resources – environmental, economic and social – not less than at present must be declined in the context of not only business but also social function in the production sector.
In 2020, the Pharmaceutical strategy for Europe 2020 was published as a white paper on the European Union’s expectations for the development of the pharmaceutical sector, including its ability to act sinergistically in achieving the Union’s development goals.
The first important point to make is that the first indicator of sustainability that the pharmaceutical industry needs to help achieve is the goal of medicines available to all citizens, regardless of income, residence, or pathology. It seems almost like a tautological statement, but only because we, in this small part of the world, are used to considering the availability of medicines an established achievement. Yet, it is increasingly plausible that the new generations in europe will not necessarily have this availability. Social welfare requires the possibility of access to effective and sustainable medicines and treatments especially for the vulnerable, with disabilities, or belonging to minorities. This goal requires a rethinking of areas and investment strategies that should increasingly be directed towards areas of medical needs that are not fully met. Just to mention some of the critical issues present in the European Union, the management of microbial resistance, in particular from Gram-negative, the emergence of systemic fungal infections as well as, of course, viral infections, senile dementias and above all the management, even just compassionate, of over 7000 rare and ultra-rare diseases.
The case of antimicrobial resistance
But the very example of bacterial resistance can retrospectively give a clear idea of what means sustainable development and help convince that terms such as “sustainability”, “objectives of sustainability”, “sustainable development” are not just slogans (although, objectively, they tend to be, in different contexts, used too frequently) but objectives and methodological tools to be applied in industrial and economic policy planning. If we imagine going back to the 1980s, in Europe or the U.S., medium to long-term planning of the therapeutic areas to invest in and a “medical need” analysis would have led (as of course it did) to a move away from research and investment in infectious diseases and toward focusing on oncological, chronic, metabolic diseases. The result is that, 40 years later, we have entered the “antibiotic crisis,” and current medical resources for infection management are less than what was available to past generations. The choice, we would say today, was not driven by sustainability considerations, but the real point is to understand how the problem could have been avoided.
Right now, for example, staying still in the area of bacterial resistance, there is a strong pressure toward curbing the use of antibiotics for both human and animal use. If these choices are justified and promoted in the context of the sustainable development model called One Health, one has to ask whether this does not lead to further disengagement in the discovery phase of new active ingredients or new mechanisms and whether, in fact, we are accompanying new generations to a future without antibacterial treatments. Similar argument could be made for rare diseases, for which in addition to the inherent difficulties of intervening on the etiopathogenic mechanism, there is a barrier to development related to revenue on very high risk investments. But this, of course, puts an increasing number of European citizens in a position of not having access to treatments, sometimes not even compassionate ones. A pharmaceutical industry that adopts a sustainable development model, therefore, must first define investment plans on medical needs projected in the medium to long term.
Ensuring the sustainability of the NHS
Immediate corollary of the above is the economic sustainability of public health systems and of general taxation that must accompany the extended accessibility of pharmaceuticals. The transformation of the pharmaceutical industry from a blockbuster model (one medicine per so many patients) to a model of personalized medicine (drugs sewn to specific genotypes or phenotypes), where the price of the pharmaceutical products has become a variable independent of its industrial cost, runs the risk of endangering universalistic health care systems and mutualistic, on the other hand to deprive entire segments of citizens of the availability of medicines. The financial adjustments that public health system gradually tend to implement to ensure at least a sufficient level of service delivery are likely to have even opposite effects in the medium term, risking blocking investments and innovation, see the so-called payback mechanism in Italy. These are issues that undoubtedly affect the sustainability of the pharmaceutical industry in the medium to long term but which paradoxically see the pharmaceutical industry sustainability goals in the medium to long term impose – for the industry and the representation – a negotiated approach that takes into account the needs to establish reimbursability models, cost-effectiveness definitions, access to generics/biosimilar that enable the “affordability” of the medicine for both the patient and the payer system. If the model enables this outcome, then the sustainability of the industry will also be preserved.
The globalized supply chain
Last but not least, a critical factor in achieving sustainability goals for the industry is the complexity of the supply chain. It is often observed that offshoring and outsourcing of some activities allow better adherence to various sustainability goals, particularly those related to impact on emissions to the environment and climate neutrality. But the globalized supply chain undoubtedly produces other critical elements that often manifest themselves in the disruption of stocks and shortages of particular drugs or even classes of drugs. The globalization and complex supply chains have in some cases resulted in a lack of technology and raw materials for the production of certain active ingredients, intermediates or excipients. In the case of price tensions, political instability or real industrial or marketing strategic decisions, suddenly entire regions may find themselves in lack of availability, which naturally impacts the weakest or most exposed population group. Further corollary is the quality of the drug. Lack of transparency, and sometimes lack of real information, about the supply chain results in the risk of low-quality drugs coming to market, contaminated by manufacturing impurities, when of course not falsified entirely. The sustainability of the pharmaceutical sector, therefore, requires the increasingly widespread adoption of good manufacturing procedures and, above all, quality control and self-assessment procedures. On the one hand, this will certainly have an impact on costs, especially of raw materials and intermediates, but it will have the advantage in the medium to long term enabling the achievement of the goals of zero-pollution of the European green deal. The emission of manufacturing residues into the environment in indeed the main source of concern for the environmental sustainability of the pharmaceutical industry. While the increasingly widespread implementation of “green” production methodologies (from flow chemistry to solvent-free techniques) makes it possible to significantly reduce the environmental emission of volatile solvents, the problem of contamination, impurities and misuse (including the discarding of not used) has the potential for a far-reaching impact in terms of microbial resistance, endocrine disruption and entry into the food chain, requiring the implementation of procedures, by industry but not only, of risk assessment and conditions of use of medicines.
The road to adherence to sustainability goals for the pharmaceutical industry requires the mobilization of resources that are of great importance but have equally great potential for economic return and reputation in the public eye.