Ana Popovic, general manager of Serbia’s generics association, Genezis, gives her thoughts on how the generics industry has progressed in the country, what room for improvement remains, and the impact of EU succession.
Where does Genezis stand in 2017 and what is keeping you busy at the moment?
“The Serbian market is a generic-dominated market, with the local manufacturers still enjoying a privileged status.”
In January 2018, Genezis celebrated its fifth anniversary in the Republic of Serbia and these days, besides the activities in Serbia, we are focused on the newly founded representative office in Montenegro.
Your association consists of international generic pharmaceutical companies. How many companies does Genezis represent and is there a possibility of a common agenda and advocacy goals since these companies are in competition?
Genezis was founded as a non-government, non-for-profit, non-political and independent association of manufacturers and marketing authorization holders of generic drugs, with a clear intention to unite and represent the common interests of all its individual members on the markets of Serbia and Montenegro.
The association gathers and supports those generic companies which provide millions of patients worldwide with quality, efficient, safe and accessible drugs. The 15 companies that we count as members include Sandoz, Teva, Gedeon Richter, Wörwag Pharma, B Braun, Belupo, Bosnalijek, Nobel Ilac, Jadran Galenski Laboratorij, Goodwill Pharma, Extractum Pharma, Sopharma Trading, SK Pharma, Unifarm Medicom and Farmalogist. Genezis gathers all of these generic companies and liaises with the health authorities in Serbia by harmoniously posing questions, providing answers, striving to unite their different interests in one common cause, all for the benefit of patients, to make therapy more accessible.
Therefore, we pay special attention to cooperation with all the relevant state and public institutions in charge of health of the citizens of Serbia and try to justifiably contribute to the implementation of adequate measures that will make the modes of quality therapy accessible to the majority of patients. It is also worth mentioning that we provide support in creating adequate legal framework, with a clear demand to ensure the treatment with generic drugs upon expiration of the patent rights of original and innovative drugs. It is our firm belief that this can contribute not only to wider accessibility of treatment but also to substantial financial savings.
The opportunity given to the generic companies on this market equals the opportunity given to patients for the treatment with those drugs used in the treatment of patients in Europe and the world, and it means an increase in the number of accessible drugs by shortening the procedures and meeting legally binding deadlines. Our challenges are related to the possibility of automatic inclusion on the Drug List, whereupon competitiveness and innovativeness on the pharmaceutical market would be stimulated.
How would you describe the Serbian generics market and its characteristics?
The Serbian market is a generic-dominated market, with the local manufacturers still enjoying a privileged status. Generic drugs outnumber the innovative ones on the Drug List, for which the funds are allocated from the state budget. Genezis Association nurtures good relationships not only with the government institutions in charge of health, but also with other associations, those that gather pharmaceutical industry as well as those that gather patients, doctors and pharmacists. Genezis Association, as a socially responsible association, makes efforts to enable access to drugs to a larger number of patients by registering and marketing quality, effective and safe drugs like those used in the treatment of patients worldwide, which are also favourably priced.
In 2017, the Serbian government acknowledged the healthcare sector as national priority and is working with the World Bank to reform it. What are your main suggestions to update Serbia’s regulatory environment and foster the growth of the sector?
In addition to the Health Insurance Law, it is important to mention the Law on Medical Devices, which has already been adopted by the Government, as well as the Law on Medicines, which is due to be adopted by the end of 2018. Specifically, the main suggestions would refer to meeting legal binding deadlines and dealing with too long procedures. If we take the drug manufacturer’s standpoint, this primarily refers to obtaining the marketing authorization permit, renewal of registration of the registered drugs and variances. It is without doubt that the contribution to the health system would be bigger by accelerating introduction or automatic inclusion of drugs on the Drug List.
One of President Vucic’s priorities is to make Serbia an EU member by 2020/2022. What will this mean for the pharmaceutical industry, and specifically what are the implications for your members?
Accession to the EU would, first of all, lead to accelerating many procedures. The regulatory frameworks would be uniform, and all the procedures would be in compliance with the EU which would make doing business a lot easier, since the principal companies of our members are located in Europe and they already do their business in compliance with EU regulations.
In the 2018 Ease of Doing Business Report 2018, Serbia improved from 91st position in 2015 to 43rd. With FDI predicted to reach approximately 420 million by 2020, what would your advice be to a CEO of a company looking at Serbia as an investment destination?
The economic growth of Serbia is on the level of the development of EU countries, which accounts for an increased number of foreign investments in Serbia, as well as the government investments in various segments of industry, especially in the road infrastructure, which will contribute to the faster economic growth in our country.
Throughout your active and productive tenure as managing director of Genezis, what have been some of the accomplishments that you are proudest of?
My satisfaction is twofold. Firstly, I think that gathering together the market competitors with a minimum of common interests is a big success; secondly, it is the position of Genezis, which has become a recognised association involved in the work of the government institutions. By this I mean that, as a Genezis representative, I am a member of the Working group under the Ministry of Health involved in adoption of the Law on Medicine.
If we come back to Serbia in five years’ time, where will we see Genezis and your members?
The membership of the Association will have grown, as it is expected that a number of the world’s generic companies will have come, due to the improvement measures brought by the Government. The regulations will be in compliance with the EU and all the procedures related to the drug authorization will be shorter. The association members, which have grown stronger, will have a wider portfolio on the Drug List, and the number of patients to whom the therapies will be available will have increased, so that along with larger allocations for health insurance, all our fellow citizens will have the opportunity to be treated with new drugs and procedures, just like the EU population is.
What is your final message to our international readership?
Increasingly improved positioning of Serbia on the Ease of Doing Business List accounts for the fact that Serbia is the right investment destination, not only for the pharmaceutical industry, but also for investments in all other industries. The official statistics showing that Serbia is one of most visited countries in the region, with Belgrade as one of the most visited capital cities, accounts for the hospitality of our people and attractiveness of our cities.