The Bulgarian generic pharmaceutical industry expects stability, not short-term solutions and opposition. The COVID-19 pandemic was and continues to be the most serious health, social, psychological and economic test for all societies. Health systems, even in the most powerful and highly developed countries, have faced unprecedented difficulties - shortages of staff, capacity, beds, equipment, medicines. An emergency restructuring of all medical care and an urgent supply of medicines and later vaccines was needed to meet the enormous needs of patients.

In a crisis situation, drug manufacturers also had to respond by redirecting their efforts and investing additional financial resources to avoid chronic shortages of essential medicines not only to treat viral infections and their complications, but also other acute and chronic diseases. All costs for substances and raw materials, together with their transport, have increased several times in a very short time due to the huge congestion and practical blockage of logistics chains.

Therefore, the most important task of governments was to prevent shortages in the drug market. Most EU countries have already learned lessons from the crisis. The European Commission has taken urgent and radical action on the basis of COVID-19's experience in setting up an organization and making recommendations to Member States for swift action in individual countries. A Pharmaceutical Strategy and an Industrial Strategy have been developed and submitted to the European Parliament for discussion. The main guidelines are:

• Removing barriers to fair access to medicines and maintaining conditions for healthy competition. Ensuring continuity of treatment for both COVID-19 patients and chronically ill patients on the basis of generic and biosimilar medicines, creating favorable and mitigating conditions for price referrals and reducing additional financial resources. burdens at increased production costs. Improving tender procedures!

• Market and regulatory reforms to ensure the availability and sustainability of the supply chain! Creating conditions for continuous supply of raw materials from third countries for the production of medicines by European manufacturers. Creation of green supply corridors and fast cross-border crossing. Short-term restoration of the production of raw materials on the territory of the EU countries.

• Promoting affordable innovation by removing barriers to generic, biosimilar and value-added medicines.

• Facilitating and accelerating the administrative services and activities regarding the regulations in the drug agencies and in other institutions related to the health of the Bulgarian citizens. Rapid introduction of electrification of healthcare as a guarantee for the effective functioning of all health care systems.

The Bulgarian Generic Pharmaceutical Association has taken all steps to prevent shortages of vital medicines, both at the beginning of the epidemic and especially during the second wave in October and November 2020, by ensuring emergency supplies of critical medicines.

The main goal of BGPharmA is to support and guarantee the implementation of the drug policy of the state by providing real access to drug therapy to Bulgarian citizens suffering from mass socially significant diseases such as hypertension, heart and brain vascular disease. These diseases cause the highest mortality in our country and unfortunately, Bulgaria is in the most unfavorable place of all EU countries.

Thanks to generic medicines, over 2 million Bulgarian citizens have the opportunity to be treated, and the NHIF to make the lowest costs, because the prices of these medicines are the lowest in Europe and each generic medicine costs 30% less than the original / reference / product. After the introduction of the first generic competitive drug on the market, the cost of treatment decreases several times a year. All countries around the world, including the richest and most developed countries, are constantly creating conditions for the availability of a large number of generic drugs in their markets, which through strong competition achieve the most favorable prices for these groups of drugs. BGPharmA appeals to the government to ensure stability in all units and processes related to the production, distribution and supply of medicines to patients, so as to prevent breakdowns and problems in stocks.

We call for mutual respect between the institutions related to the regulation and payment of medicines for citizens, increasing the efficiency of work by preserving their independence and the division of activities of these extremely important units, such as the recommendations of the World Bank.

We believe that the team of the Ministry of Health will successfully cope with this important, difficult and responsible task in a period of caretaker government. Sudden, short-term, unjustified changes can only destabilize the fragile balance achieved in the drug supply system! At the moment, it is important for all participants in the healthcare processes to unite in convincing and motivating Bulgarian citizens for rapid and mass vaccination to achieve mass immunity, which will guarantee overcoming economic difficulties and stabilizing the upward development of the economy and the state. In our opinion, the funds invested in healthcare should not be seen as costs, but as strategic investments. Only a healthy nation can build a strong state! The Bulgarian generic business will continue to be a guarantor for providing efficient, safe and reasonably priced treatment to Bulgarian citizens!

The Bulgarian Generic Pharmaceutical Association is a representative organization of Bulgarian and foreign generic and biosimilar manufacturers. BGPharmA unites over 15 productions in Bulgaria with over 17000 employees, which represents 10% of the generic productions in Europe and are one of the largest taxpayers in Bulgaria. The member companies of BGPharmA create over 4% of the country's GDP. The Association is a member of the European Generic and Biosimilar Association - Medicines for Europe, which represents the European generic, biosimilar and value-added medicines industries, which provide high-quality medicines at competitive prices for millions of European patients. The companies represented by Medicines for Europe provide nearly 170,000 skilled jobs in Europe and invest up to 17% of their turnover in research and development. The vision of European manufacturers of generic and biosimilar medicines is to ensure sustainable access to high-quality medicines for all European patients, based on 5 important pillars: patients, quality, value, sustainability and partnership.