Generics: can they ensure viability of National Health Systems?
Use of generics has broadened patient access to quality treatments in the past 10 years. At the same time, in the rest of Europe, generics serve as the perfect chance for ensuring viability of national Health Systems.
More specifically, increased generics’ penetration in the Greek market could ease the cost burden on the Greek NHS at a rate equal to that seen in other European markets – for example, without any competition from generics, EU governments would be forced to spend an extra 100 billion Euros in 2014.
1.What exactly are generic drugs and what market share do they hold globally?
Jacek Glinka: A generic medicine is developed to be the same as a medicine that has already been authorized (the ‘reference medicine’). It contains the same active substance as the originator medicine, and it is used at the same dose to treat the same disease as the reference medicine. Therefore, generic medicines and originator products are authorized to the same standards of safety, quality and efficacy. All that is done at the highest standards of approval, quality, manufacturing (GMP) and post-marketing surveillance of generic medicines.
2. In what ways does the use of generic drugs assist the sustainability of the Greek NHS?/In what ways would Greece benefit from the wider use of generic products?
Jacek Glinka: Across the European healthcare systems, generic medicines offer an incredible opportunity for sustainability: patient access to high quality medicines has more than doubled over the past 10 years thanks to generic medicines.
While generic medicines already contribute to the sustainability of healthcare budgets, the value that they bring to Europe can still be expanded. Generic medicines currently make up 56% of dispensed medicines within Europe. At the same time, these account for only 22% of pharmaceutical expenditure.
The sustainability of NHS is a concern in all the countries. As Medicines for Europe president, I have been participating in meetings early this summer with Ministry of Health of several countries where we have encouraged discussion around that topic. In Greece, as you know and have reported, healthcare spending was severely affected by the economic crisis, leading to a decrease of approx. 40% during the period 2009-2015.
This is where generics play their part – now in Greece still 7 in 10 medicines are original products (protected & non-longer protected), in market value (Deloitte, June report). With a higher penetration of generics, the NHS could potentially save as much as the other European markets – for example, without generic competition, European governments would have had to pay an additional 100 BN EUR in 2014.
Milan Černek: Factors such as the aging population or increasing incidence of chronic diseases escalate pressure for the healthcare budgets everywhere. Generic drugs reduce cost of treatment or, in other words, we could treat more people for the same money, making sure at the same time that all Greek patients have access to high quality medicines.
3. What market share do generic drugs hold in Greece?
Milan Černek: Government planned to reach 60% penetration of generic products until 2014. On the contrary, according to EOF data, the Greek pharmaceutical market is still dominated in value by original products (protected & non-longer protected). According to SFEE data for the first 6 months of 2017, the actual penetration of generic drugs is 21.3%.
In our local portfolio, generics stand for less than 20% and we plan to increase this share through bringing in Greece for example MS treatment as well as a strong HIV portfolio. Just in the last days we’ve obtained price approval for HIV equivalent (generic) of Truvada (tenofovir /Emtricitabin); with this combination, we are bringing the opportunity for payers to make significant savings for the HIV treatments – based on our estimates, the potential saving for the healthcare system, if 50% of patients will use generic product, could be of 2 million EUR annually or, in 3 years’ period, it could come close to 7 million EUR, compared to the situation where the use would be exclusive with the branded product. But for the local system to get full advantage of generics, we need to higher penetration than the current one.
4.What are the reasons for the low penetration of generic drugs in the Greek market?
Jacek Glinka: Generics not only have a low penetration rate, but the increasing trend from the last years has slowed down recently because of a number of factors.
First, registration process is among slowest in EU which delays the entry of generics. A solution we’ve seen in other countries is an accelerated of the process, which can give better chances to generics. Thinking in an integrated manner, improvements can be done in the pricing and reimbursement system as well, as the current unpredictability leads to decreases in efficiency of measures.
Now, second in my opinion to boost generics use in Greece would be, as we’ve seen in other countries, the introduction of incentives for all stakeholders; such as higher discounts for generic products, digressive margin, to be attractive for pharmacists to support generic substitution.
Not least, what is missing is a monitoring mechanism to track the uptake of generics.
5.What is Mylan’ s CSR activation?
Milan Černek: We are proud to say that we contribute both financially as well as with our own team to help local communities in Greece. Last year, we’ve supported more than 400 children and their families in need, while our employees gathered nearly 150 hours of volunteer work. We’ve worked with A Child’s Smile, Together for Children Association, The Ark of the World, Desmos – in the Ladies Run, as well as being involved in blood donation.
This is in our DNA for as long as we’ve been here in Greece; Mylan in Greece has evolved into a diversified healthcare company, with some of our medicines having helped Greek patients for more than 60 years.
We directly employ 130 talented individuals in Greece and, though working with 6 manufacturing units in the country for some of our medicines, we indirectly create a number of 1,000 jobs. It is therefore fair to say that, based on our history and operations in the market, Mylan is a strong local player in Greece, providing both generics and innovative products from across a wide range of therapeutic areas.
6.Is Mylan planning to expand its portfolio in Greece and activate in new therapeutic areas?
Milan Černek: Our portfolio is currently ranging over more than 50 branded, generic medicines and OTCs – across some of the most important therapeutic areas. These are medicines used for example in cardiovascular diseases – for hypercholesterolemia, which reduce risk of infarct and stroke. We are key player in CNS segment, with wide portfolio covering treatment of depression, schizophrenia, epilepsy. Our portfolio includes also painkillers, derma products and flu vaccine – on this latter, 30% of people are protected against flu each year use a Mylan vaccine; with this affordable-price product, we’d like to continue to contribute at increasing vaccination rate in Greece. We have also popular OTC products like Pulvo or Omacor.
On top, most recently for example we’ve brought generics in the HIV area, as well as an innovative product – Dymista – in allergy. On medium term, we will start to play in the biosimilars market, with some very interesting therapies. In a nutshell, on short terms, this year, we launch or will launch 19 new products or line extensions.
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