Esteemed Members, as the Association of Research Based Pharmaceutical Companies (AIFD), since our foundation in 2003, we are continuously pursuing our raison-d’être, which is to increase and improve the access of patients in Turkey to innovative medicines and therapies and to create an “ethical and transparent” healthcare business and working environment.
During the past 18 years AIFD has steadily emerged in Turkey as the valued, respected and effective civil society organisation in healthcare sector in Turkey. For AIFD reaching this position, lion’s share of credit should no doubt belongs to you, AIFD member companies; who value human health above all considerations, strive relentlessly to find solutions to the unmet needs in healthcare sector, trust in the potential and future of Turkey and keep investing in, generating employment, share your global know-how and experience in the service of the population , to you, AIFD member companies, who keep creating value for the people, patients and the economy of Turkey. We would like to convey our gratitude for your continuous support, belief and dedicated efforts during these 18 years.
During the year of 2020, as the Board of Directors elected at the 17th Ordinary General Assembly held on February 14, 2020, we continued to work in line with the above mentioned organisational mission; 2020 is a year which will probably be remembered by all of us, as one, if not the most, extraordinary year of our lives. We present to you our activities of this unusual year under the main headings together with the annual report.
2020 was a year that was out of extraordinary not only in our 18 years of AIFD history but probably of the last hundred years of our planet’s history. The pandemic caused by the new type of SARS-CoV-2 virus that was first observed in China during the last months of 2019 became the sole determinant of the global agenda. One week after 11 March 2020, the day Turkey has officially reported the first patient, the total number of patients reported worldwide had already approached 250 thousand. Today, the total number of patients reached 100 million, and the total number of deaths approaches 2 million. The number of patients in Turkey alone, while you are reading these lines would have probably surpassed two and a half million people.
Well before the first patient was reported in Turkey, AIFD had established a round-the-clock information sharing network among its member companies’ HR and workplace safety managers to share information pertaining to work and working place safety and health. Following the announcement of the first COVID-19 patient in Turkey by the Minister of Health, we have issued a circular to all our members on March 13 recommending them to suspend all face-to-face contacts of their field sales representatives, the first in the Turkish healthcare industries and fully in line with our commitment towards the community and our employees.
As the pandemic was at the focus of AIFD agenda as well, the AIFD Board of Directors met almost weekly from March to July to evaluate the developments. With the guidance of the Board of Directors, AIFD prioritized, planned and carried out a massive support for the fight against the pandemic in our country. During the same period, we had invited several opinion leaders to AIFD General Managers meetings, again held almost weekly and listened to their evaluations.
AIFD provided, together with its members, critical support to the fight of our Ministry of Health against the SARS-CoV-2 pandemic in several fields. Mechanical respirators which were in dire need in intensive care units during the first weeks of the pandemic outbreak were provided by AIFD from its resources after consultation with Public Health Agency (Halk Sağlığı Kurumu) and the General Directorate of Public Hospitals and distributed to the respective hospitals as suggested by the General Directorate of Public Hospitals.
AIFD and its members also made cash donations to the Presidential campaign of "We suffice to ourselves, Turkey" (“Biz bize yeteriz, Türkiyem”).
During the same period, following the humanitarian support proposals from our member companies to the healthcare system of Turkey, we as AIFD coordinated all these contributions and thus provided in kind donations worth over 3.5 million TL to the General Directorate of Public Hospitals in 2020.
When the donations made directly by AIFD members to our healthcare system are included, AIFD total humanitarian aid to Turkey amounted to over 22 million TL.
In line with the strategic goals we shared with you in our General Assembly in February 2020, we planned to work in very close cooperation with all our stakeholders. The most important elements of this plan were the AIFD strategic initiatives such as AIFD BIO-Startup programme, the launch of Clinical Trials Report commissioned to IQVIA and of the Biotechnological Medicines book, and the initiation of the Patient Associations Development Academy.
Though the priorities have changed during the year, we had nevertheless kept these main strategic issues in focus, adapted them to the new era and new processes.
In 2020, we transposed the AIFD BIO-Startup program into the "CoronaSprint" project, supported by the Istanbul Development Agency, in cooperation with TUSEB, and focused entirely on developing solutions to the SARS-CoV-2 epidemic and its secondary effects.
After a two-month long continuous marathon within the scope of the BIO-Startup CoronaSprint Project, the solution roadmaps developed by 16 startups for the problems related to SARS-CoV-2 were evaluated and a monitoring and tracking mechanism was established to meet all the identified needs of these projects. Using the BIOS-tartup program graduate pool as a resource, the CoronaSprint project has turned into a self generating ecosystem. As AIFD, our aim is to ensure the continuity of this ecosystem and to keep it alive. We will continue to work together with our member companies, TUSEB and other relevant public and private institutions and organizations in order to realize projects that require technology development, business model change or innovations in policies.
Last year in the 2019 Annual Report, we had mentioned the IQVIA report (financed by EFPIA ) that highlights the contribution of locally conducted clinical trials to Turkey and to its important potential role in global competitiveness. The report prepared from the outset in a inclusive manner with the contribution of all stakeholders including the public entities, on one hand made a comparative assessment in the world and in Turkey the development of clinical trials that account for 62% of the global R&D investments; on the other hand, developed concrete proposals and a roadmap in line with the 11th Development Plan target of "establishing Turkey as the leading clinical trials country in its region." The study, completed by the end of 2019 with the conviction that to reach the common goal the public authority and private sector should work together, was planned to be launched in March 2020 in collaboration with TITCK and TÜSEB; and the next step was planned to establish a calendar and priority roadmap together with these stakeholders to target, in the medium term, to at least double the size of clinical trials in Turkey.
However, due to the SARS-CoV-2 pandemic, "Benefits of Clinical Research Strategy for Turkey, a Roadmap for Innovation -Based Growth " report, prepared in 2019 by IQVIA with the financial assistance of EFPIA under the co-ownership of AIFD, TITCK and TUSEB was shared with the public after a five months delay, on September 17th during the TUSEB Biotechnology Program.
Report launch keynote speeches were delivered by Prof. Dr. Emine Alp Meşe, Deputy Minister of Health, the Republic of Turkey; Assoc. Prof. Dr. . Tolga Tolunay, Director of the Turkish Pharmaceuticals and Medical Devices Agency (TİTCK); Dr. Mete Hüsemoğlu, Chairman of the AIFD Board of Directors and Ms. Nathalie Moll, Director Geneal of EFPIA. Following the presentation of the report by Ms. Şule Sencer Akbil, IQVIA Engagement Manager, a panel titled " The Importance of Clinical Trials for Turkey and What Type of a Joint Working Model to Implement the Roadmap?” was organised. Prof. Dr. Ahmet Gül from Istanbul Univ. Medical School was the moderator of the panel where Ms. Nihan Burul Bozkurt, TITCK Clinical Trials Department Head; Mr. Kutluhan Taşkın, from Presidency of the Republic of Turkey, Directorate of Strategy and Budget, General Manager of Plans & Programs; Dr. Hasan Arslan, Deputy General Manager of Public Hospitals, Ministry of Health; Prof. Dr. İlhan Satman, Board Member of the Turkey Institutes of Health and Mr. Özgür Ertok, Country Manager of IQVIA Consulting took part as panelists.
As AIFD, in line with our basic mission which we define as “working with all our stakeholders to facilitate the access of patients in Turkey to the newest treatments”, we always state that clinical trials that enable us to understand the effect and safety of new drugs and treatments on people are of vital importance for human health. We can safely state that our country has a significant clinical research capacity. One of the main findings of the report shared with the public is that clinical research produces high added value in the fields of economy, health and science. Policies to be implemented in cooperation with the public-private sector will enable our country to become one of the most important actors in the world in clinical research, as well as to establish an ecosystem that feeds other valuable elements of the pharmaceutical value chain such as basic research, manufacturing and export. As AIFD, we believe that this report will be an important roadmap for all stakeholders of the pharmaceutical industry.
Another very important AIFD event that should be mentioned was the launch of the book "Biotechnological Medicines" to the science community, which is the product of a long endeavour of more than two years, that took place on the closing day of the TUSEB Biotechnology program.
The book, compiled with the original and objective research of academicians expert in their fields and with the unconditional support of AIFD, is a very large reference source for biotechnological medicines that covers all aspects of the production, quality, pre-clinical and clinical studies and product safety of biological and biosimilar drugs and is responding to a genuine need.
As AIFD, we always state that patients should be at the focus of a "healthy" functioning health system and we advocate that patients should be an independent party in the decision processes in the health systems.
In 2020, we implemented a very important program in line with this vision within the framework and roadmap of the AIFD Patient Initiative. AIFD Patient Associations Development Academy was initiated as a two-year online training, mentoring and consultancy program for 9 patient associations under the Social Innovation Center, in line with the outcomes of the earlier patient association mapping study. The program, which will continue in 2021, will have its first graduates in 2022.
2020 has also been a year during which AIFD had intensive corporate communication activities. We transposed the EFPIA European #WeWontRest campaign, with the tag #ÇareBulanaDek in Turkey. Besides adapting EFPIA generated content to Turkish and Turkey, following the suggestion of AIFD Corporate Communications Executive Group, we conducted a vibrant campaign by using content produced by the MPN, our corporate communications partner. Immediately after the SARS-CoV-2 pandemic appeared in Turkey, our focus shifted naturally to convey from all our social media accounts the pandemic related actions of our members to the attention of the public. Encouraged and motivated by the positive feedback we received we embarked on a second series, this time about our members’ innovation stories relayed by their General Managers and Country Leads. With this momentum, our corporate communication efforts will continue in 2021 with contents generated by our members.
The details of all the work done by the strategic management committees, apart from the initiatives and activities shared above, are available in the body of this annual report.
The most common and top priority issue of all pharmaceutical suppliers, registration /permit holders in Turkey, for almost ten years since 2011, continues to hold this primordial and important spot in the industry agenda: the Euro exchange rate to be utilised in pricing calculation of pharmaceuticals. The Euro-Turkish Lira pharma pricing exchange rate was kept constant from July 2011 until May 2015; in 2015 and subsequent years the conversion rates were updated at rates well below the then current foreign exchange rates; as a result the financial sustainability of the industry is severely damaged. After the two adjustments made to the exchange rate to be used as the basis of pharmaceuticals price calculation, the Euro echange rate to TL was fixed at 2.1166 TL/Euro in 2016, then to 2.3421 TL/Euro in 2017, with an increase of 10.7% over 2016 fixed rate.
In 2017, as a result of the rapid and serious depreciation of the Turkish Lira against the Euro for the first time after many years, the current exchange rate had reached the double of the fixed exchange rate used in pharmaceutical pricing at the end of the year. In 2018, in addition to these issues, under the constraints of both the inflation and the budget discipline rules, the industry was further confronted with a pharma specific exchange rate fixed below the rate dictated by the legislation; the Euro exchange rate for pharmaceuticals pricing was fixed at 2.6934TL/Euro, well below the 2.8866 TL/Euro FX rate stipulated by the legislation. 2019 was the second year of diversion from the applicable legislation. With an amendment to the 2015 legislation determining pharma specific exchange rate calculation scheme, exchange rate multiplier which was defined at 70% in 2015 was reduced to 60% and subsequently 2019 pharma specific exchange rate was fixed with 26.4% increase over previous year at 3,4037 TL/Euro for 2019 and with 12.1% increase at 3.8155TL/Euro for 2020.
We respect the efforts of the public administration to contain the health expenditures to ensure the sustainability of health services, which are in line with global trends in healthcare. On the other hand, in a market that is growing in volume under demographic trends and aiming to meet the quality expectations of the marketplace, from the industry standpoint, the policy aiming to keep the value of the sales shrinking or stable or marginally growing is far from being sustainable. We maintain that the access of the patients in Turkey in particular to newly developed medicines and treatments can be improved only after a broad consensus on the pricing policies. We are fully aware that we have a long way to go to achieve a fully healthy and sustainable pricing and pharmaceutical financing structure.
The “localisation requirement” was the other important agenda item of 2020 to which as the representatives of the global pharmaceutical industry we devoted substantial time and efffort since the last quarter of 2014. We have communicated during the last five years whenever possible to all of our stakeholders that the “localisation requirement” policy included in the 10th Development Plan and the 64th Government Action Plan would have potential negative consequences due to its implementation method, specially its divergence from the principle of “encouragement” to which it should have had to adhere, that the current localisation requirement does not fully coincide with Turkey’s global competitiveness objectives, that the expected economic gains would be limited. We shared our vision that Turkey, which already has a strong local manufacturing capacity, should instead focus in areas with substantially higher value added sectors such as research and development and specifically in clinical trials and thus become a global player in this field; we have also shared our alternative model proposals to realize this vision. The Health Services Pricing Commission decisions regarding the products to be "inactivated", that is, to be excluded from the reimbursement scope as per February 2018 were published first on February 8, 2017, then on April 25, 2017 and finally on January 19, 2018, and subsequently implemented. Although it was defined in five consecutive stages, only the products included in the first two stages of the original decision were removed from the reimbursement. Turkish Pharmaceuticals and Medical Devices Agency officials declared that the other three stages would not be implemented. The EU Commission, launched a panel investigation in April 2019 unfortunately alleging that the implementation of the localisation requirement in pharmaceutical sector in Turkey is in breach of the WTO agreement. As AIFD, we hope that this intergovernmental process would result as soon as possible in compromise with optimum results for our country.
Two years ago, in 2018, while assessing the previous year’s pharmaceutical sector, we had underlined as the most positive and important development in 2017 was the membership of the Turkish Pharmaceutical and Medical Devices Agency to PIC/S (Pharmaceutical Inspection Convention/Scheme) and emphasised that this heralds the acceptance path of the Turkish Medicines Authority to the membership of global networks, which also means the globalization of the Turkish pharmaceutical sector. As AIFD, we always emphasize the importance of "global" competitiveness, "global" standards, being a "global" brand as a country, institutions and sector. We also warmly welcome and fully support Turkey Pharmaceuticals and Medical Devices Agency’s initiative to apply as the next step to the membership of ICH in order to become a global pharmaceutical authority ; we express once again clearly that we will provide every support to our institution in this process. We express and will continue to do so on every platform that it is vital that our institutions always act with such “global” vision.
2020 has been a truly lost year due to the inability of the scientific evaluation commissions to work effectively in the licensing processes, an ongoing issue since 2019. The number of applications waiting to be registered has reached almost three times the highest annual evaluation capacity of the Authority, with approximately 2000 pending applications, as per end of the year 2020. As AIFD, together with other sector representatives, we will continue our endeavours in 2021 as well to improve on the delays in the licensing processes, insist on waiving the cost-oriented approach pursued in the prioritization process, without any concession on the scientific evaluation approach, to ensure that the patients access of innovative drugs is not further delayed.
Fully in line with TITCK’s vision of becoming a “global reference authority” and the Turkish pharmaceutical sector vision of “global competitiveness” we firmly advocate both the revision of the pending Regulatory Regulation and the development of the guideline for biosimilar products and their implementation, in line with this vision while not cutting corners, without compromising from scientific evaluations or the global standards.
As AIFD, in 2021, just as we have been doing since our foundation, in constructive and positive cooperation with our stakeholders and partners, we will continue to enhance our contribution in the healthcare of the population and the economy of Turkey towards our firmly believed vision of “enhancing and improving access of patients in Turkey to innovative pharmaceuticals and treatments and enabling an ethical and transparent business and working environment in the healthcare sector”.
We would like to express our sincere thanks to you, all the members of the the large AIFD family, for being with us during this very challenging and honourable journey.
Sincerely,
Dr. Mete Hüsemoğlu
Chairperson
Dr. Ümit Dereli
Secretary General
