Esteemed members,
We as AIFD have been working since our establishment in 2003 and #WeWontRest, in order to increase and improve the access of patients in Türkiye to innovative medicines and treatments, and to provide an “ethical and transparent” work and working environment in the field of health.
On the 100th anniversary of the founding of the Turkish Republic, and in the 20th year of the AIFD, we as AIFD has come to the fore as a respected and effective civil society organization representing the innovative pharmaceutical industry in the field of healthcare in Türkiye. The lion’s share of credit for our present position on the 20th anniversary of AIFD , undoubtedly is due to you, the member companies of AIFD, who put human health above all else, who offer their global knowledge and experience to our country and create value for the people, patients, and economy of this country by striving relentlessly (#WeWont Rest) to find solutions to unmet health needs, trusting and investing in Türkiye's potential and future, creating employment, and valuing human health above everything. We would like to convey our gratitude for all your continuing support, belief, and efforts for the last 20 years.
We held our last ordinary (18th) General Assembly on October 22, 2021, due to the global 2020 SARS Cov-2 pandemic conditions, which suddenly entered our agenda as all over the world and then set the whole agenda. In 2022, we continued our work with the Board of Directors elected at the 18th Ordinary General Assembly. In this report, under the main headings we present to you all the activities we have realized in this year, which covers our exit process from the global pandemic.
As you are all aware, in 2021, AIFD Board of Directors set the strategic priorities for the 3rd decade of the 21st century under four main headings;
- Improving access to innovative medicines,
- To assure compliance with international regulatory standards,
- Ensuring a sustainable price structure,
- Making Turkey an innovation center for the pharmaceutical industry,
- To develop a common value system for AIFD members and the industry.
In order to conduct a more effective and efficient policy advocacy and to contribute to the shaping of the health agenda for the needs of the future in all these priority areas as AIFD, while continuing our patient initiative and corporate communication activities effectively and strongly, we have established an "Advocacy Core Committee", reporting directly to the Board of Directors since 2021.
The issue of the euro exchange rate for pharmaceutical pricing, which is the top priority and the most important common agenda for all stakeholders of the Turkish pharmaceutical industry, has maintained this priority position for 10 years. The fact that the euro exchange rate was not updated in the period between July 2011 and May 2015, the fact that the updates made in 2015 and afterwards fell far behind the current euro exchange rate, and the significant depreciation of the Turkish lira against foreign currencies, especially in 2017, 2018, 2021 and most recently in 2022, have seriously damaged the financial sustainability of the pharmaceutical sector, despite 3 exchange rate adjustments in 2022.
Following two adjustments made in 2015, the euro exchange rate for drug pricing was set at TL 2.1166 in 2016 and then at TL 2.3421 for 2017, an increase of 10.7% compared to 2016. In 2017, as a result of the rapid and significant depreciation of the Turkish Lira against the euro for the first time in many years, by the end of the year the current exchange rate was twice higher than the exchange rate used for pricing medicines. In 2018, which started with these difficulties, the pressure of both inflation and budget discipline led to an exchange rate adjustment that was lower than the exchange rate update required by the legislation in force, and the euro exchange rate used as the basis for drug pricing for 2018 was set at 2.6934 TL, when it should have been 2.8866 TL according to the legislation. 2019 was the second year in which the trend of deviating from the legislative requirements that started in 2018 continued. An amendment was made to the legislation determining the euro exchange rate for pharmaceutical pricing and the exchange rate coefficient, which was set at 70% in 2015, was redefined as 60% and accordingly, the exchange rate for 2019 was set at 3.4037 TL with an increase of 26.4% and for 2020 at 3.8155 TL with an increase of 12.1%.
In 2021, while the legislation in force required a 26% increase in the calculation of the periodic euro value, on February 19, the exchange rate adjustment was limited to 20% and the periodic euro value was set at 4.5786TL. With this decision, for the third time, the legislation in force was not applied as required. Not even a month after the 2021 periodic euro value was published, it fell below half of the current euro value.
2021, especially starting from November, was the second period of rapid depreciation of the Turkish lira in the last 10 years, and as a result of this rapid depreciation, the periodic euro value used in pharmaceutical pricing fell even below 30% of the current value.
In 2022, an exchange rate adjustment of 37.43% was made in accordance with the legislation in force and the periodic euro value was set at 6.2925TL. Due to the continuing depreciation of the TL against the Euro during the year, a second exchange rate adjustment was made in July 2022, bringing the periodic Euro value to 7.8656TL. By December 2022, the current euro value was approximately 2.5 times the periodic euro value. The issue of financial sustainability, which we, as all stakeholders of the Turkish pharmaceutical industry, have been persistently raising, led the administration to bring forward the exchange rate adjustment envisaged for 2023, and the periodic euro value entered into force as 10.7577 with an increase of 36.77% in December.
Despite all the constructive approaches of the administration, the periodic euro value is still half of the current exchange rate from day one, which should be underlined as the serious sustainability issue for the pharmaceutical industry.
As AIFD, together with other sector actors, we have been strongly voicing that the current regulation will not be sufficient to move forward on this issue, which concerns the entire Turkish pharmaceutical industry, and that the entire drug pricing regulation must be revisited.
Drug pricing policies, which is the root cause of the financial sustainability problem has a fundamental and vital repercussion on the healthcare system in the access to innovative medicines. The results of the WAIT study, which is conducted annually by IQVIA covering all European countries and showing patients' access to innovative medicines approved by the European Medicines Agency (EMA) in the last four years, show that patients in Türkiye can only access 15% of these innovative medicines as of 2021, and that this access rate has decreased from 20% in the last four years to 15% today. As AIFD, we communicated the alarming results of this study to all stakeholders in a highly transparent and effective manner in 2022 and created common working grounds to improve this situation. We will continue these efforts in 2023 without interruption.
You can find the developments in 2022 on financial issues related to access to medicines, especially pricing, the legislation published and enacted in 2022, and what we, as AIFD, have done in this field in a comprehensive manner under the heading "Price and Reimbursement Policies".
2020 was a lost year in terms of licensing processes due to the inability of scientific evaluation commissions to work effectively. By the end of 2020, the number of applications awaiting marketing authorization had reached approximately 2000, almost tripling the Agency's maximum annual evaluation capacity. 2021, which started with such a challenging "legacy" for TITCK, was a year in which this huge burden was resolved to a significant extent and the Agency started to work effectively and efficiently again. In 2022, as in 2021, AIFD, together with other industry representatives when necessary, continued the efforts to improve the delays in the marketing authorization process, to abandon the cost-oriented approach in the prioritization process, and to accelerate the access of innovative medicines to patients without compromising the scientific evaluation approach. For the year 2022, the number of files pending license evaluation at the Agency and those whose preliminary review has been completed and are waiting to be evaluated is still high, and the waiting time in the slot is calculated as approximately 1 year in the first half of 2022. In the last period of 2022, it was observed that this period decreased to approximately 6 months as a positive development.
You can find a comprehensive overview of the developments in 2022 on the licensing of medicinal products for human use, particularly on prioritization, the legislation published and enacted, and what we, as AIFD, have done in this area under the heading "Licensing and Compliance with International Standards".
AIFD's vision for the Turkish pharma sector is congruent with the official vision of Türkiye's 11th Development Plan. This vision is to ensure that the Turkish pharma sector achieves global competitiveness in all links of the pharmaceutical value chain. When we talk about global competitiveness, one of the most important and "sine qua non" requirements is for the national pharmaceutical authority to become a global brand. In 2018, while evaluating the previous year, we underlined that the most positive and important development for the pharmaceutical industry in 2017 was TİTCK's membership to the Pharmaceutical Inspection Co-operation Scheme (PIC/S) and emphasized that this important development, which means the first stage of the acceptance of Türkiye's pharmaceutical authority into global networks, is in fact a very important step towards the globalization of Türkiye's pharmaceutical industry. Our Agency continued its vision of integration with global networks, which it started with PIC/S, with the ICH membership, which we, as AIFD, strongly supported. 2022 will go down in history as the year when TITCK becomes a reference authority recognized by the World Health Organization. As AIFD, we always express the importance of "global" competitiveness, "global" standards, and being a "global" brand as a country, institutions, and sector, primarily for patients and the healthcare system, and at least as much as a development policy element. We will continue to express on every platform that it is vital for our institutions to always act with this "global" vision.
As AIFD, in line with our core mission of #WeWontRest and work together with all our stakeholders to ensure that patients in our country have access to the latest treatments, we always emphasize the vital importance of clinical research, which enables us to understand the impact and safety of new drugs and treatments on humans, on human health, its strengthening effect on scientific and clinical practices, and continue to emphasize that our country has a significant clinical research capacity. The biggest impact on "economic development", one of the two main axes of our AIFD value story, comes from clinical research, which is the biggest link in the global pharmaceutical value chain. Prepared in 2019 by IQVIA with the support of EFPIA and shared with the public in the last quarter of 2020, one of the main emphases of the clinical research report, which is a roadmap for the Turkish pharmaceutical industry, was that clinical research generates high added value in the fields of economy, health and science. We have always stated and continue to state that the policies to be implemented in this field in cooperation with the public-academia-private sector will make our country one of the most important players in clinical research, first in our region and then in the world. In 2021, the clinical research investments of the pharmaceutical companies represented in AIFD in Türkiye doubled compared to the previous year and amounted to USD 325 million. In 2022, Türkiye became the leading country in its region in terms of the number of active clinical trials being conducted, just as stated in the 11th Development Plan. We share the pride of this important achievement with all our stakeholders and our members who have contributed to it, and once again emphasize our desire and determination to take our country even further in this field.
As AIFD, one of our main strategic priorities is to "make Türkiye an innovation center for the pharmaceutical industry." You can find our achievements in 2022 under the "R&D and Innovation" section of this report for new initiatives in the field of healthcare, especially clinical research, and "mutual recognition agreements" that will play an important accelerator role in our global competitiveness.
In 2020, within the framework of the AIFD Patient Initiative and in line with the determined roadmap, the AIFD Patient Associations Development Academy Program was launched under the leadership of the Social Innovation Center, and 9 patient associations, which were determined in line with the outputs of our previous patient association mapping study, participated in the program consisting of two-year online training, mentoring and consultancy modules. Graduating 9 patient associations in 2022, the program continued to provide training and consultancy services by incorporating 7 new associations during the year and continued to provide consultancy support to 9 graduated associations.
As AIFD, the KUM (KVKK Compliance Model) (KVKK: Personal Data Protection Law) Project was implemented as a pilot project in 2022 with the aim of solving the general problems experienced by patient associations in Personal Data Protection Law related issues, and KVKK audit services were provided to 5 patient associations with the support of a specialised law firm. The problems commonly observed at the end of the study were shared with the participation of all patient association representatives in the third of the #Together for Health Gatherings webinar series.
In addition, a needs survey was conducted with patient associations in order to ensure the correct and effective use of digital communication tools, which have increased in use especially in the post-pandemic period and to understand the needs of association representatives in the field of digitalization. The research, which consisted of qualitative and quantitative evaluation processes, was completed with the participation of 35 Patient Associations and 2023 projects were determined in line with the emerging needs.
In 2023, we will continue the Patient Associations Development Academy with an expanded training program, the KUM project by increasing the number of associations it serves and expanding the scope of the # Together for Health Gatherings webinar series.
Our achievements on patient initiative, which is one of the long-term strategic agenda item of AIFD, under the title of Patient Initiative Activities.
2022 was another intense year in which the value of innovation and the contribution of innovative treatments to human life, to the society and to the economy were explained through interviews, written and visual content in print, digital and online channels within the scope of AIFD corporate communication activities. In 2020, we had launched EFPIA's Europe-wide #WeWontRest campaign with the Turkish hashtag #ÇareBulanaDek. In 2022, as in 2021, in addition to adapting the content produced by EFPIA to Turkish and Türkiye, we continued an effective public relations and press communication with the content produced by our corporate communication partner MPN under the guidance of the AIFD Corporate Communication Steering Group. We adapted EFPIA's new #makingtheimpossiblepossible project into Turkish and continued to explain the value of innovation with the Turkish version of the slogan "#WeWontRest until we make the impossible possible."
The results of the perception survey we conducted at the end of 2021 guided our corporate communication activities in 2022. As mentioned above, one of our important communication topics in 2022 was the results of the WAIT study conducted annually by IQVIA, which shows access to innovative medicines in European countries.
You can find more comprehensive information on AIFD's corporate communication activities in 2022 under this topic.
In 2022, a first for AIFD was the AIFD Innovative Medicines Symposium. The event, assigned by the Board of Directors at the beginning of 2022 and planned under the leadership of the Advocacy Core Committee, was held on December 7 at the Hacettepe University Conference Center as a physical meeting with widespread participation of industry, public, specialty and patient associations, allowing online access. This event will be repeated in the years to come as an AIFD brand activity.
In addition to these initiatives and activities that AIFD has shared with you in the form of main headings above, you will be able to find in the report the details of all the activities carried out by the strategic management committees.
In line with the AIFD vision of “increasing and improving the access of patients in Türkiye to innovative medicines and treatments and providing an ethical and transparent business and working environment in the field of health”, which is our reason for existence in our 20th year as since our establishment, #WeWontRest and we will continue to enhance our contribution to the health of our people and the economy of our country by cooperating with our stakeholders with a constructive approach.
We would like to express our sincere thanks to you, all the members of the large AIFD family, for being with us during this very challenging and honorable journey and celebrate our strong unity on our 20th anniversary.
Sincerely,
Dr. Mete Hüsemoğlu
Chairman of the Board
Dr. Ümit Dereli
Secretary General
