Over the past five years, the cosmetic industry has met with several legislative changes. Within the new legislative package, including the new REACH and CLP, it is important to find a comfortable routine that will minimize costs while staying effective and compliant with all regulations.
Interview with Pieter Dylst
Read the interview with Pieter Dylst.
What are the main challenges in pricing and reimbursement of generics?
"At this moment, governments throughout Europe are faced with constrained healthcare budgets as a consequence of the financial and economic crisis. At the same time, governments have to find ways to accommodate the entrance of highly expensive innovative medicines. This combination means that governments are continuously looking for ways to generate savings on healthcare spending. In this regard, expenditures on generic medicines have been an attractive target. Many governments throughout Europe have imposed measures which severely affect the generic medicines industry such as price cuts, paybacks, etc. This worrying trend threatens the long-term sustainability of the generic and biosimilar medicines industry in Europe, which is essential to ensure future competition in the pharmaceutical market and increase patient access."
Find out more:
Why are supergenerics getting more attention from big pharma players?
"First of all, I would like to call products of this type ‘value-added medicines’. In the past, the originator side of the industry developed medicines without worrying too much about the continued development of innovations for these active substances. Nowadays, several pharmaceutical companies are looking at those existing molecules and applying innovative concepts to develop medicines which deliver considerable improvements for patients, payers and/or healthcare professionals. For example, the added value may be created thanks to better health outcomes, quality of life, improved tolerability, better adherence, less frequency, reduction of medical errors or any other innovative solution addressing unmet needs for the key stakeholders."
"Pharmaceutical companies realise that there is still a lot of untapped potential with medicines of this type. While the development of highly innovative medicines with new treatment mechanisms is becoming more and more challenging, our industry is prepared to apply modern mechanisms on existing molecules to create value for all the various stakeholders."
Will patients pay higher prices for better-formulated or re-innovated generics?
"At this moment, the biggest challenge in Europe is that authorities and payers do not recognise the added value that medicines of this type bring to stakeholders, including patients. Instead, they apply the generic medicines pricing structure and no higher prices are allowed. This has resulted in pharmaceutical companies deciding to market products in the US but not in the EU, ultimately denying patient access to innovative treatment options."
What are the policy-driven changes impacting generics sales worldwide?
"Overall, we see that uptake of generic medicines is positively influenced by many factors. First of all, education and information remain important as some stakeholders in some countries worldwide still have questions on the quality, safety and efficacy of generic medicines. Also, INN prescribing/generic substitution has led to the largest uptake of generic medicines in European markets."
How do you see the future of the generics industry?
"With the great patent cliff behind us, the generic medicines industry is faced with the development of generic medicines which are more complex to manufacture (e.g., respiratory products), biosimilar medicines and value-added medicines. The development of these types of medicines require much more investment compared to traditional generic medicines, and governments and authorities need to realise this and adapt their policies."
"Also, I expect more consolidation in the industry, as already observed over recent years, which will be crucial for the industry to increase economies of scale in this increasingly challenging environment."
Interested in this topic?
Advanced Protein Aggregation & Characterization
This training will focus on occurrence of particles in drug products, effects of protein aggregates, critical process and parameters. Attendees will gain overview of on utility and limits of predictive experiments, learn concerns from the authorities and relevant aggregation guidelines, and more.
Corporate Compliance & Transparency in the Pharmaceutical Industry
This two-day conference will serve as a platform for an open and dynamic dialogue with HCPs and patients to achieve common goals. Learn how to embed compliance in the business and develop one simple system for managing compliance & transparency in a complex and regulated environment.