Spain – Javier Anitua, Managing Director
What more needs to be done in Spain to communicate the value that generics bring to stakeholders who set prices?
The sustainability of Spain’s health system is vital for all of its citizens. The pharmaceutical industry cannot continue to suffer in the regulatory framework through short-term measures like price cuts. Rather, our stakeholders must find more meaningful, long-term measures such as access to substitution through affordable medicines like generics. Without generic medicines, there are no originators, and vice versa; the two are interdependent. If the industry creates more accessibility with the same quality, safety and efficacy of medicines after patents expire by using generics, then Spain can immediately reduce health costs and benefit from further innovation. This country is below the European average in terms of generic medicines volume and value penetration and there is no price difference between reimbursed off-patent brands and generic medicines. This is a big issue for generic companies because of the difficulties surrounding changing patients’ consumption habits. When patents expire, patients will not change their medication if there is no financial incentive. The future of developing new medicines will depend on the proper penetration of generic medicines in Spain.
Is the awareness of generics where it needs to be in Spain now, particularly at the pharmacist level?
There is still a lack of communication that needs to be emphasized greatly. The government and all stakeholders need to clearly state the role, efficacy, quality and safety of generic medicines and why they are bioequivalent. Generic medicines meet the same requirements in terms of control, authorization and commercialization in Spain as the originator drug. Other countries like France have encouraged substitution (dispensing and prescribing), and France saved nearly EUR 2 billion (source: Gemme) in 2013 as a result. There is no such incentive scheme in Spain at the pharmacist level despite mandatory prescription by INN. Furthermore, implementation varies for each autonomous community, meaning we have 17 markets. Therefore we should trigger this encouragement, as well as price differentiation and incentives for patients.
Generics arrived later to Spain than in other European countries. Is this the primary reason for Spain lagging behind the rest of Europe, or does the conservative nature of Spanish culture play a role?
There is a need for education in this regard. Spain has evolved and progressed to a degree in that the interaction and consumption of generic medicines is increasing, but there is a lack of clear information on the role generic medicines play regarding the sustainability of the healthcare system and how they are bioequivalent to any other branded product in quality and efficacy. These kinds of educational attitudes should be administered by the authorities not only to patients but health professionals as well.
You have been actively involved in the maintenance of Spain’s current pharmacy model, and Mylan Spain has been involved in providing training for pharmacists in the country. What concerns you most in terms of a change to the system?
The need of patients to be more and more assisted is exploding geometrically because of an ageing population in a country with limited resources. The population pyramid of Spain looks more like a nuclear cloud which means that by 2050 nearly 40 percent of Spaniards will be above 64 years old (Source: Population Ageing and Development 2009: www.unpopulation.org) . There is a high correlation between the health needs and ageing. Spain must adapt its resources to the needs of the society. In addition to an ageing population, advances in medicine means we will have more chronic patients which triggers a support role from the pharmacist. Society’s current way of living is gradually limiting availability for taking care of ageing people.
The good news is that Spain has 22,000 pharmacies, nearly as many as Germany with half the population. This works out to be about 2200 people per pharmacy on average (Source: PORTALFARMA). This provides us the capacity to have a pharmacy within walking distance from home in 99 percent of the Spanish population. We have the framework that will help with the crucial role of pharmacist, but to truly resolve this significant social issue, we need to make these pharmacies viable. In Spain, the average price of medicines has dropped by 27, 1 percent in five years, between 2005 and 2010 because of short-term price cuts (source: FARMAINDUSTRIA 2011). This means that the average Spanish pharmacy has lost its net margin by 34 points over the last five years, with a net margin of less than seven percent. (Source: Antares Consulting 2014) This trend cannot continue for long.
One solution involves exploring other incomes to the pharmacies, which is why Mylan Spain is pushing its manifesto with the support of the main Spanish Societies of Pharmacists. This initiative involves the recognition of preventive role that pharmacies can play through professional pharmaceutical services. As far as drugs related services are concerned, an example could rely on the dispensing of medicines with added value like PDS, which guarantees treatment compliance and prevents errors when taking medicines (Source: Study about PDS in Baix Llobregat, SEFAC, 2012). The lack of adherence in Spain has an estimated cost in one year of more than 11 million of euros (source: Sessions of Treatment Adherence,2013). So, Spain could save €11 million of euros per annum and prevent 14,000 casualties applying measures such as PDS. The role of generics is also crucial in the sense of reducing costs by higher substitution instead of price drops. Essentially, we need to look at the long-term, meaning we need more cooperation. We need to establish an agreement of sustainability for pharmacies and provision of medicine with every industry stakeholder. Innovation needs to come, but to provide that innovation we need to activate the use of generic medicines instead of creating more short-term price cuts.
What impact can Mylan’s recent investments in biosimilars have?
We aim to launch all of Mylan’s innovations in Spain. Apart from having a diversified portfolio with more than 1300 products worldwide, Mylan Spain will also add its full strategic growth vectors or markets, which include biosimilars, injectables and ARV treatments. Just like generic medicines, we need to incentivize the use of biosimilars whenever a biological product’s patent expires. This necessitates the establishment of a clear framework regarding pricing because they are more complex to produce than standard formulations. If we want to attract this competition that will enable access to high quality medicines to 7 billion people, we need to establish these incentives when patents expire.
Where does Mylan fit in the Spanish market?
Flexibility is crucial for this to happen, but the most important aspect is the role we play. We have to be very active in education in generic medicines, and we must continuously provide access to high quality medicines to Spanish people. Mylan applies the same standards of quality in all its facilities worldwide, and Spain is of course a testament to this. We also have full integration of our supply chain and 80 percent of our products are supplied internally. That is also a significant difference in terms of reliability and quality of our products which is significant in our industry. So on one side we have quality, and on the other a broad portfolio with innovative products to come.
How important is Spain in Mylan Europe?
The relationship between Mylan Spain and Mylan Europe is one of the most fluent I have seen, and as I mentioned I like the entrepreneurial culture in Mylan. We are always encouraged to share best practices. We have been pioneering initiatives in terms of balancing local and global culture. We recently launched a blog in Spain to support the community retail pharmacy model. We want to create a think tank through this blog, and to gain adherence from patients and pharmacists across Spain in order to enable Spanish pharmacy viability (blog: www.apoyatufarmacia.com).
Portfolio services are also crucial. We want to trigger the supportive role of the pharmacist to be more focused on preventive treatment. One great example of these professional services encouraged by Mylan is the HIV screenings, which can be run at the pharmacy level and thus it is very convenient for patients. The youth of Spain is increasingly becoming infected (Source: Santiago Moreno, HP of Infectious Diseases in Hospital Ramon y Cajal, 2014) and the difficulty for going through diagnosis can act as a deterrent. This screening has already been piloted in the Basque country for five years in some pharmacies. The prevalence of the disease is one percent. If we need to screen 100 to find one infected patient at a cost of less than €2000, the benefit of immediately treating a person plus preventing infections is extremely cost-effective. We want to trigger these approaches as often as possible where limited resources can provide great benefits to the Spanish society. The protocol of connection proves how relevant is cooperation amongst all health care professionals is. We hope to mimic our model in the Basque Country around all of Spain. The model works and is cost-efficient, providing added value and revenue to pharmacies and benefiting all of society.
You have a broad array of experiences; what drove you to come to Mylan?
I was very attracted by the mission of Mylan to provide access to high quality medicines to seven billion people, which is incredibly thrilling and meaningful. I also really liked the entrepreneurial and action-oriented culture that the company offered, while being a global company with more than 20,000 employees. Given its balance between local and global, Mylan is one of the fastest interaction-oriented companies that exist, respecting local differences while taking advantage of our unique global platform.
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