Author: Maja Kambovska, Healthcare System Partner at Roche Macedonia and Member of the AmCham Healthcare Committee
*The article in Macedonian language, published by Kapital can be found at the bottom of this page.
Advancing healthcare through IP
Intellectual property, by the innovation it enables, has supported transformational advances in healthcare. Life expectancy in Europe has risen by up to three decades over the last century. Cancer mortality rate has declined by 21% since its peak in 1991 in Europe and HIV has been transformed from a death sentence to a manageable disease. In the past 30 years alone, more than 1100 new medicines have been introduced in Europe. These medicines have protected, improved and extended many lives. Research and development of new medicines demand many years of intensive effort, considerable investment, and a willingness to accept significant risk. On average, only one to two of every 10’000 molecules complete the journey from lab bench to bedside. By providing a time limited protection, patents give innovators the degree of certainty they need to continue to invest in the future and to turn science into valuable medicines.
How intellectual property rights can be leveraged to improve our healthcare system and deliver more access to innovative medicines
For innovative companies, it is the existence of robust IP provisions that makes it possible to identify, develop and deliver innovative solutions to some of the most challenging health issues. With responsible IP use as a foundation, pharmaceuticals companies are able to collaborate with governments, health systems and payers in order to support access to medicines.
As North Macedonia is preparing for EU accession and gearing its economy to become competitive and meet the standards of the EU single market, the government should consider the role of a strengthened IP system in encouraging the transition to an innovation-based economy delivering societal benefits and economic growth.
The Macedonian legislation on intellectual property rights is to some extent aligned with the EU acquis. When it comes to the rules applicable to innovative medicines, for example, the rules on patent protection are well defined, and the supplementary protection certificate for medicinal products is regulated, providing for a period of five years additional protection.
There is room for improvements in the legal and institutional framework, in particular to make sure that the IPRs framework and the Law on medicines and medical devices, as the primary law regulating medicines, are mutually aligned and fully harmonized with the latest EU rules. Such interventions take time and require a dialogue between the government, the private sector and all other stakeholders, in order to bring realistic and long-term benefits to the economy and society. But there are several ways in which IPRs linked to innovative medicines can help improve our healthcare system immediately:
- Recognizing the value of innovation by all healthcare system institutions, including government, healthcare providers and others. The value of innovative medicines goes beyond the effectiveness of treatment. It extends to providing a better quality of life for the patients, less burden on the healthcare capacities, less burden on the caretakers. In the long run, a healthier population contributes more to the work force and to the economy and leads a happier life. The value of innovation, underpinned by IPRs, should be considered in decision making processes such as health technology assessment (HTA) and reimbursement inclusion, conclusion of managed entry agreements, clinical guidelines, national strategies etc.
- Public procurement procedures that take into consideration the innovative nature of medicines and the value of innovation. The current practice of slow and lengthy tender procedures often results in delays in the availability of hospital medicines for the patients. Yet, the national public procurement rules allow for speedier procedures in cases when exclusive rights, including IPRs, apply, under certain conditions, which can be used in the case of innovative medicines. This can contribute to more efficient delivery of healthcare services, in particular at the hospital level where timely and continued access to innovative medicines can be lifesaving.
- Adoption of the new Law on medicines harmonized with the EU rules. The Law on medicines is an important enabler of an ecosystem founded on innovation. The new draft Law contains modernized rules on quality and safety of medicines, requirements for sustainable supply, and other provisions that support innovation. The new Law on medicines is a requirement in the EU accession process, and the draft has been prepared in a transparent, consultative way, so its adoption should be prioritized.
- Investments in R&D and innovation and partnerships between the public and private sector. The government should prioritize health and economic policies that incentivize innovation, and should join forces with the business community in partnership initiatives. Companies that have an inherent innovation mindset, a global presence and state of the art knowledge should use these assets for advancing healthcare in the country not just for medicines related innovation policies, but also for topics such as digitalization or funding of healthcare.