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| Frequently Asked Questions |
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Question :
How can sales of counterfeit drugs be prevented?
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Answer :
Patients should buy their drugs from their regular pharmacies and should definitely not buy drugs over the internet. Furthermore, distribution channels must be supervised closely and purchases should not be made from unreliable wholesalers. Finally, penal sanctions towards counterfeit drug producers should be more dissuasive.
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Question :
What is the connection between R&D activities in drugs, and the investment climate ?
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Answer :
When we look at models worldwide, we see that the pharmaceutical sector and R&D activities play an ever more important role in national economies. Governments implement various incentives to encourage these studies. Investments by the pharmaceutical industry increase in countries offering such investments. R&D has a more important role in the pharmaceutical sector compared to other industries. As an example, in 2004, total resources allocated for R&D in the pharmaceutical sector has exceeded US$ 60 billion. Estimates show that this figure is expected to double by 2010.
R&D activities being long term and difficult as well as expensive increases the risks taken by the research-based pharmaceutical companies. Following an R&D process taking 12-13 years, thousands of molecules have to be scanned and a long-winded development phase completed in order for a drug to reach the shelves.
A new drug that is discovered at the end of all these processes offers patients a newer, more effective, and safer treatment option. Economical value of more effective and safer new drugs and the contribution of this value to the economy cannot be underestimated.
A drug’s adventure from molecule to finished product costs around EUR 900 million. (Source: EFPIA – European Federation of Pharmaceutical Industries Associations web site).
In order for long-term R&D investments to be made, adopted policies should not support only generic drugs. Such practices prevent innovation, and may affect the investments of innovative and research-based pharmaceutical companies in our country negatively in the mid- and long-term. After a certain period, these will start to hinder patients’ access to more effective and safe innovative drugs.
Our country currently attracts only one-thousandth of R&D investments worldwide. Investments coming to our country will also enable know-how and technology transfer.
In order for the pharmaceutical industry to grow, policies developed with a strategic approach and vision, are needed. Ireland has adopted transparency and innovation in drug policies and encouraged long-term investments. Creating a transparent, convenient and effective regulatory environment, forming even the educational policies in the country in order to supply infrastructure to targeted industries, demonstrates Ireland’s vision and determination. Today, Ireland is in the position of Europe’s drug manufacturer with exports of over US$ 48 billion. The country’s national income per capita has reached US$ 38,000.
While total drug expenditures in Ireland are realized as EUR 1.21 billion, taxes paid by companies in the industry to the Irish government is around EUR 3 billion. In other words, the pharmaceutical sector in Ireland has created three times the added value in taxes as the drugs consumed. The government pays for domestic drug expenditures with the taxes collected from the industry.
While Ireland’s 2004 drug exports, excluding chemicals, was EUR 17 billion, Turkey’s drug exports is only EUR 316 million. Currently, more than 1/3 of Ireland’s total exports consist of pharmaceuticals.
Share of R&D investments within the GDP is 1.1 percent in Ireland, while this rate is 0.6 in our country.
The country which was once the poorest in Europe and a source of migration has now become the richest European country after Luxembourg.
There are no reasons why our country shouldn’t be inspired from this success. In an environment where R&D is encouraged, where conditions for fair competition prevail and where transparency is a fundamental principle, Turkey is also in a position to be able to make a significant breakthrough in the pharmaceutical industry. What is needed is to take the steps to improve the investment climate and adopt consistent policies to move the industry to the future
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Question :
Why is the enforcement of Intellectual Property Rights and Data protection important?
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Answer :
Costly as well as long-term and challenging R&D activities increase the risks taken by the research-based pharmaceutical companies. An R&D process takes 12-13 years on the average and includes scanning tens of thousands of molecules as well as a difficult, lengthy development process. The cost of one drug from discovery till being placed on the shelves is around EUR 900 million on the average.
In order for research-based pharmaceutical companies who undertake millions of dollars’ worth of R&D activities to meet this investment and create resources for new research, protection of intellectual property rights within a legal framework plays a significant role.
Enforcement of patent and data protection under property rights is among the most important factors supporting R&D in the pharmaceutical sector. Patent enables the drug’s generic not to be produced for at most 20 years. Data protection, on the other hand, foresees public authorities not to share the drug’s data with other companies during the 6 years following the initial application for registration. Data exclusivity may not be added to the 20-year patent period. If the drug is registered on the 14th year while it is under patent protection, a 6-year data exclusivity is observed and evaluated within the 20-year patent period.
In order for pharmaceutical companies to make long-term investment plans in our country and for Turkey to attract global foreign direct investments, it is very important for intellectual property rights to be enforced according to international standards.
China and India are two striking examples to the case.
In order to attract international investments, China offers both significant incentives in recent years and also adopts international standards in protecting international property rights.
Similarly, India has also attached increasing importance to intellectual property rights and has become a center for clinical studies. In this extremely fast-growing sector, the country attracts nearly US$ 100 million of investments each year. In the next four years, these revenues are targeted to be US$ 1.5 billion.
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Question :
Are drug expenditures in Turkey high compared to other healthcare expenses?
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Answer :
There are disputed points and ambiguity in this subject. Certain difficulties prevail in comparing and estimating public healthcare expenses and drug expenditures. The rate of total drug expenditures to total healthcare expenses in Turkey is known to be around 25% (according to National Healthcare calculations made in accordance with the OECD methodology). This seems to be high in OECD terms. We can list some of the reasons why drug expenditures in our country seem high as follows:
It is clear that in Turkey, number of physicians and patient beds per capita are low compared to OECD countries; therefore there are less visits to doctors and also high patient density per doctor. This results in meeting healthcare services primarily by drugs supplied from pharmacies. It should be considered that in Turkey, costs and prices of healthcare service factors (primarily such as labor, service and laboratories) are significantly low compared to global standards. Contrary to OECD, in Turkey, public healthcare estimates include drugs used in hospitals within drug expenditures. In OECD countries, this item is evaluated among hospitalization costs. Furthermore, while hospitals buy drugs with low prices through tenders, they invoice them to institutions over market prices. Therefore, the share of drugs within both total healthcare expenses and in particular within public healthcare expenses, seems artificially high.While in other OECD countries, drugs used by “hospitalized” patients are supplied and administered by hospitals, 30% of hospitalized patients in Turkey buy their drugs from independent pharmacies. Considering that in OECD countries, drugs used by hospitalized patients are evaluated not as drug expenditures but within the general healthcare expenses, this is seen as another reason why drug expenditures in Turkey seem statistically high. Public reimbursement institutions reimburse public healthcare institutions (MoH and Universities) for hospitalization costs over heavily subsidized prices. This subsidization is roughly estimated to be at least 35%. The burden for this subsidization is met by the Ministry of Health from the General Budget, and by Universities. However, this burden is not reflected on healthcare expenses of reimbursement institutions. This in turn causes the drugs/total healthcare expenses rate in the public sector to seem high against drugs. Contrary to OECD countries, in spite of recent partial arrangements, Turkey continues to reimburse most OTC drugs on the same level with prescription drugs. This proportionally increases Turkey’s public drug expenditures in comparison with other countries.
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Question :
Are original drugs expensive in Turkey?
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Answer :
Original drugs in our country are the cheapest in Europe. In our country, patients have access to original drugs more cheaply than patients in Europe.
The “reference pricing system” has been enforced as of February 2004. With the new regulation enforced in accordance with harmonization with the EU, cheapest prices from among drug prices of the cheapest five countries in Europe are accepted as a basis. These countries are currently determined to be Italy, Spain, Greece, Portugal and France. The reference price for our country is the cheapest price for a drug in these five countries. Original drug prices in Turkey are on the average 28% cheaper than the cheapest in the 5 referenced countries.
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Question :
Do companies that are not members of the AİFD not conduct any research?
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Answer :
These companies mostly produce generic drugs. In other words, they produce generics of drugs developed by research-based pharmaceutical companies, whose bioequivalence with the original is proven. Of course, this does not mean that they do not conduct any research at all. However, R&D activities are not as fundamental for these companies as they are for the research-based pharmaceutical companies.
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Question :
How do you supervise practices?
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Answer :
For supervision, we have a supervisory committee that receives and evaluates relevant complaints. Complaint mechanism has started to function as of April 2004. There have been 120 complaints until present. Most of them were member companies’ complaints about other members. Complaints from physicians (2) and from the press (2) have been evaluated by the AİFD Promotions Supervisory Board and have been decided upon following due process.
Promotions Supervisory Board consists of 7 people, two of whom are independent and five of whom are company representatives. Secretary General of AİFD is the impartial chairman of this board and does not have a vote. The board is created with people who are respected in the pharmaceutical industry, whose objectiveness is beyond suspicion and who were elected with the companies’ votes.
Complaints may come from companies, individuals or the press; and anybody may file a complaint by citing a news article in the press as reference. For example, a member company may declare that they do not find the conduct of another member company compliant with ethical rules. First of all, we recommend high-level contact between general directors and enable a discussion between them. If no results are achieved from this discussion, then the matter goes to the Promotions Supervisory Board.
At this stage, Secretary General of AİFD starts the mechanism. Reporter of the board reviews the subject, and prepares a report. We include the matter in the agenda of the first meeting. In the meeting, we listen to the company representatives along with the report, and the board members discuss to arrive at a decision. If representatives of the relevant company are members of the Promotions Supervisory Board, then in the interests of impartiality, they cannot play a part in the decision-making process.
Complaints may also come from IEIS (Pharmaceutical Manufacturers Association of Turkey). Similarly, a member company may file a complaint about an IEIS member. We do not have any sanctions over non-member companies, but we notify IEIS. They then warn their own member concerning the subject. We also have a joint supervisory committee. This committee may also be considered as a board of appeals. Any unresolved questions are evaluated at this board, which may be deemed as a joint board of both parties. This board’s functions have so far never been required, but it has been structured to be appealed to when necessary.
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Question :
How does data protection encourage developing new drugs?
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Answer :
Developing a new drug and presenting it in service to humanity requires a period between 12-13 years. Therefore, when the drug is launched in the market, around 7-8 years of patent protection period remain. This is valid for markets of developed countries such as the US and European countries. In other countries, for example in Turkey, receiving registration for a new drug may require longer than 2 years in some cases. In such a case, patent protection period is reduced even more. On the other hand, the company who spends close to EUR 1 billion to develop a drug needs to have this investment returned. This is necessary in order to allocate new resources for R&D activities and to pursue developing new drugs. Therefore, protecting the data concerning the drug that the company has discovered after years of allocating manpower, time, and resources for an additional rational period against unfair commercial exploitation, even if the patent period has expired, shall enable a breather for the return of investment and encourage continuing such activities.
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Question :
How much prevalent is the counterfeit drug problem worldwide?
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Answer :
According to the findings of the World Health Organization, 6% of drugs worldwide are counterfeit. A wide range of counterfeit drugs from hypolipidemia to cancer drugs have been found in the US. Drug distribution in our country is generally safe, however in some developing countries, it is estimated that 50% of drugs are counterfeit. This rate goes up to 80% in Africa. Drugs with high sales rates are counterfeited in particular. For example, most of the malaria drugs in Africa are targets for counterfeiting. Most of these counterfeit drugs are produced in India and China.
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Question :
How would a counterfeit drug be recognized?
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Answer :
If the product is being sold at a significantly cheaper price, this should be noted. It is also useful to check whether there are any signs of a product label having been removed or changed, or whether the expiry date has been changed. A usual practice of the counterfeiters is to remove the original label, and change it with a fake one. To do this they use lighter gas, acetone or some other solvent that may leave a sticky trace on the container. Furthermore, colors on the fringes of the label may be faded or vanished because of the solvent. Counterfeiters usually buy products near expiry date and change labels. Therefore, it is necessary to seek clever tampering on the product label and compare it with previously bought products. On the packaging the paper grain, dimensions and thickness of labels, paper’s gloss and whether there is any difference on the gloss may also be checked. Difference in types and fonts of characters, printing color and embossed characters are also signs of a counterfeit drug. When a counterfeit drug is detected, the doctor, the pharmacy that sold the drug, the legal producer and the Ministry of Health should be notified.
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Question :
Is data protection sufficiently enforced in our country?
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Answer :
There are two important questions in practice. As a member of the World Trade Organization (WTO), in accordance with the Trade-Related Aspects of International Property Rights Agreement (TRIPS), Turkey was obliged to enforce data protection as of 1 January 2000. Decision no 2/97 of the EU Association Council and the Council Directive no 87/21 (has become Council Directive no. 2001/83 upon subsequent amendments) mentioned in this decision foresaw the enforcement of data being protected for at least 6 years as of latest by the end of 2000.
However, Turkey has enforced data protection with a delay of 4 years. In this case, it is still not clear whether data protection will be enforced for registration applications made between 2000-2005.
Another question is having a registration application in any European country to be accepted as the beginning of data protection period in Turkey, also. Considering that it sometimes takes 2 years to conclude a registration application in our country, it is clear that this procedure practically decreases the data protection period.
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Question :
Is it correct for laws protecting intellectual property rights to be interpreted as “We will have to buy drugs more expensively”?
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Answer :
Here, we believe that whether the drug to be purchased shall reach treatment targets or no, and whether it increases the patient’s quality of life should be considered primarily. As generic drugs may be produced without high R&D costs, original drugs naturally have higher prices than generic or copy drugs. Discovery of an original drug requires a long and costly R&D process. Data protection means the research data for a drug that has been discovered after a long and difficult R&D process is not shared with other companies for 6 years following the application for registration. Data protection does not mean the drugs to be more expensive.
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Question :
Is the patent protection in Turkey enough?
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Answer :
In our country, the Patent Law has been enacted in 1955 and started to be enforced as of 1999. This law offers protection only to those products that have been patented after 1995. However, as many products were patented before this date, they cannot avail themselves of patent protection in our country.
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Question :
It is said that a National Drugs Agency needs to be established. What shall the function of this agency be, and what should it be?
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Answer :
As AİFD, we believe that the Turkish pharmaceutical sector is in need of such an agency. The National Medicines Agency may play a significant role both during the processes of globalization and harmonization with the EU; and in order to establish international standards in the pharmaceutical industry and also to increase its global competitive power. It shall increase the level of institutionalization in the industry rapidly.
However, while this agency is being founded, a comprehensive discussion including all the industry should be created, and the approach should be compliant with international norms and standards. In case it is founded and it functions with the correct approach, the National Medicines Agency may be an institution that accelerates harmonization with the EU and removes bureaucratic obstacles hindering foreign capital.
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Question :
What are AİFD’s efforts on ethical promotion practices?
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Answer :
One of the most important items in the agenda of the pharmaceutical sector is principles of ethical promotion. Ethical promotion is among the topics with priority for AİFD ever since it was established.
In April 2003, three months after AİFD was established, upon the Ministry’s request, work on the Draft Promotion Regulation has been initiated. In addition to the Regulation Regarding the Promotional Activities of Medicinal Products for Human Use published on the Official Gazette dated October 12, 2003, we have prepared the AİFD Code of Promotion considering the EU Directive (2001/83/; 2004/27/EC) which set the basis for the Regulation, World Health Organization Ethical Criteria for Medicinal Drug Promotion, Turkish Medical Association’s Principles of Physician and Drug Promotion, and the rules of international pharmaceutical manufacturers associations (IFPMA and EFPIA) of which we are a member. During our studies, we did not ignore the experiences reflected since 1990 in the Promotional Guideline of the Pharmaceutical Manufacturers Association of Turkey (IEIS).
Successful promotions realized in our country since the beginning of the 1960’s; publications, warnings, complaints of professional organizations such as the Turkish Medical Association and the Turkish Pharmacists’ Association, ABPI-Association of British Pharmaceutical Industry’s promotion principles reflecting 50 years of experience and EU legislation has been shedding light on our studies, now as in the past. The initial text of AİFD principles were approved by AİFD’s Board of Directors on January 28, 2004 and enforced on 1 April 2004. The principles have been revised in August 2004 to include comprehensive explanations and more restrictions on promotion.
In consideration of EFPIA’s new rules from November 2004, relevant EU Directives published until 2004 and warnings from our members, we have published the second version of AİFD Code of Ethical Practice in November 2005. Principles have been published in Turkish and English. Furthermore, an abridged pocket guideline that can easily be referenced by representatives has been published as 11,000 copies in September 2004 and distributed to sales teams of member companies.
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Question :
What are the phases of development for a new drug ?
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Answer :
The initial phase of drug research consists of determining a molecule from among thousands developed as a result of extensive lab studies, which may have a positive effect on the disease, or may contribute to the quality of life.
Patent application is made for the newly discovered molecule (to the American Patent Institute in the US). If the application is approved, patent rights up to 20 years are received.
For the new molecule, an application is made to an authority in the pharmaceutical industry (FDA in the US) and research approval is received. First of all, lab studies are conducted to research whether the molecule is toxic or not, and to determine its pharmacological effects.
For the molecule found safe in laboratory environment, a new application is made to receive license for clinical studies, and trials on people. Clinical trials on people, which are conducted on a voluntary participation basis, consist of 3 phases, and take a long time.
Phase I is the first phase, and between 20-80 healthy volunteers participate in a controlled hospital environment. The purpose is to determine the drug’s dosage, how it is metabolized in and expelled from the body and any acute side effects.
Phase II is the second phase, conducted with the participation of 100-300 volunteer patients who have the disease that the drug aims to treat. The purpose is to collect data on the efficacy and safety of the drug.
Phase III is the third phase, conducted with 1.000-3.000 volunteer patients. The purpose is to see the effectiveness and side effects of the drug, and to compare it with standard therapy.
In some cases, clinical studies continue after the drug is approved and launched in the market.
Phase IV is the phase where the purpose is to collect data on the long term risks and benefits of the drug, as well as its appropriate dosage of administration.
This whole process takes on the average 12-13 years. (Source: EFPIA – European Federation of Pharmaceutical Industries Associations web site).
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Question :
What are your comments on the steps the government has taken in the pharmaceutical sector recently? What are the changes realized in this area?
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Answer :
As a result of the changes made in 2005, significant improvements have been realized in healthcare services, and patients’ access to drugs has improved significantly. We can list the positive changes as follows:
Nearly 10 million green card holders have been offered outpatient treatment and drug access, 34 million SSK members have become able to buy drugs from independent pharmacies. Thus, access to drugs and treatment has increased for a total of 44 million people.Drug use per box has increased by 17% in 2005 and 13% in 2007.As a result of voluntary price reductions by the Turkish pharmaceutical sector, the increase in real terms in public drug expenditures has become 3% in 2005 and 5% in 2006. Significant savings are realized in public drug expenditures. The government supplied more drugs with lower YTL cost, to the benefit of patients. While significant healthcare benefits were realized on the one hand, the burden on public finances was reduced. Furthermore, transfer of the SSK hospitals over to the Ministry of Health and opening private hospitals to SSK and other insurance members have been an important step in extending healthcare services all over the society.
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Question :
What does bioavailability mean?
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Answer :
Bioavailability is used to denote the proportion of the administered drug that passes to systemic circulation without being transformed. Generally, when determining bioavailability, a single dosage is administered to 12 healthy volunteers and within the time period that passes from the administration of the drug until its release is completed, the drug’s plasma concentration curve is determined.
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Question :
What does bioequivalence mean?
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Answer :
Bioequivalence is two drugs with same or similar pharmaceutical form having equivalent effects.
In order for bioequivalence to be demonstrated, disintegration and dissolution tests and the drugs’ maximum plasma concentrations (Cmax), time to reach Cmax (tmax) and areas below the drugs’ maximum plasma concentration – time curve (AUC0-∞) in generally 24 healthy volunteers are compared.
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Question :
What does generic drug or copy drug mean?
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Answer :
When the patent period and the data protection period of the original drug expires, its equivalent with the same active substance is produced in compliance with legal and scientific rules. This is called the generic product. Copies of an original that are manufactured before the protection period expires can only be called copy drugs. These are generally of unproven bioequivalence and may constitute a health risk.
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Question :
What does it mean for an original drug and generic drugs to be equivalent?
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Answer :
Generic drugs are drugs that registration authorities permit to be sold because they believe they have similar effect with the original drug. A generic drug should have the same amount of similar active substance as the original drug, should be in the same formulation (as tablets, capsules or ampoules) and should have the same effect on the patient. Until around 20 years ago, it was believed that the same amount of active substance showed the same effects, and was therefore equivalent. However today, in order to register generic drugs, it should be proven that the drug’s distribution in the body (bioequivalence) and accumulation (bioavailability) is also the same as the original drug.
Many drugs that were given registration in the past in Turkey have been recalled from the market by the Ministry of Health, because they could not present studies proving bioequivalence.
Furthermore, whether biotechnological drugs that are based on the latest developments can have generics is a matter of dispute. It is still being discussed whether generic drugs that are products of biotechnology should get registration following similar processes as the original drug, even if they include the same active substance.
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Question :
What does it mean to be a research-based pharmaceutical company?
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Answer :
Research-based pharmaceutical companies work to discover new drugs and therapies. This means allocating resources, technology, and working environment to tens of thousands of scientists and for many years of studies.
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Question :
What is a ‘generic’ drug?
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Answer :
When the legal protection period for an original drug expires, pharmaceutical companies may launch similar drugs in the market. These are called ‘generic drugs’. A generic drug should contain the same active substance in the same quantity as the original. It should be in the same formulation and pharmaceutical form. Its bioequivalence with the original drug should be proven.
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Question :
What is an ‘original’ drug?
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Answer :
Original drug is an international term used for a new drug that has been proven to have a positive effect on a particular disease after extensive research, laboratory and clinical studies; which is based on a patented molecule, and which previously had no other similar drugs.
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Question :
What is Data Protection? Which sanctions does it impose? What is its period?
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Answer :
Data protection is an intellectual property rights procedure that aims to encourage research-based pharmaceutical companies who allocate a large part of their patent period to R&D activities on the drug. It protects innovative companies and those who develop drugs to increase the quality of life from unfair competition. It prevents data submitted to authorities by the research-based company within the scope of registration application to be referenced by competitor companies, or to be disclosed to them.
Data protection period is 5 years in the US and was 6-10 years in the EU countries until the end of 2004. As of this date, the said period has been accepted as 8+2+1 years in the EU. Turkey enforces data protection for 6 years as of January 1, 2005.
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Question :
What is drug promotion? What kinds of activities does it include?
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Answer :
Drug promotion includes explaining basic properties of a new drug to physicians and pharmacists. This is done by sales representatives and both physicians and pharmacists thus find the opportunity to update and improve their knowledge on new developments and treatments in the pharmaceutical sector. Thus, it is a task that has important dimensions in patient healthcare.
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Question :
What is the contribution of innovative drugs to society?
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Answer :
Innovative drugs increase the quality of life for people and extend their lifetimes. However, this is not their only contribution to society. Using these drugs correctly and appropriately enables employees to do their jobs and reduces disabilities, operations, hospitalizations. They reduce the cost of treatment. They increase the quality of healthcare services, while reducing costs. Furthermore, they contribute to the development and enhancement of the pharmaceutical industry, and increase investments. Innovative drugs create value for the society in all their aspects.
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Question :
What is the cost to research-based pharmaceutical companies of the process to develop a new drug?
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Answer :
Research-based pharmaceutical companies spend around 15-20 percent of their budgets on R&D activities. This rate is higher than some high-technology industries such as electronics, aviation or automotive. Recent research shows that the average cost for the process of discovering a new molecule and developing it into a drug reaches around EUR 900 million (Source: EFPIA – European Federation of Pharmaceutical Industries Associations web site).
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Question :
What is the purpose of research-based pharmaceutical companies?
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Answer :
Our purpose is to enable Turkish people’s access to new and original drugs and to contribute to finding effective solutions to the problems of the healthcare industry in Turkey. We work to establish a climate in the healthcare sector where results from R&D efforts are used for the benefit of patients and where innovative and effective healthcare services are offered to the society as a whole.
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Question :
What is the significance of protection of intellectual property rights for patients?
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Answer :
Enforcing intellectual property rights in a healthy way plays a significant role in the development of innovative drugs and therapies. The patients then have stronger access to these drugs and therapies. Not enforcing intellectual property rights will slow down R&D activities and make patients’ access to new drugs and therapies difficult.
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Question :
What is your opinion about the current state of the Turkish pharmaceutical sector?
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Answer :
Turkey has one of the leading pharmaceutical markets worldwide. The market has grown by 10% in US Dollars in 2006 and reached a level of US$ 9.9 billion in consumer prices. Considering the healthcare needs of our increasing population and the necessity for the society to have increased access to drugs, it is clear that this market shall continue to grow in the future.
Turkey’s successful economic performance in recent years has had a positive effect on the pharmaceutical industry as on many other industries. Opportunities and potential offered by the market has led many international pharmaceutical manufacturers to establish partnership with Turkish companies. There has been a mergers and acquisitions trend in the last few years, particularly in generic drug companies.
Today, we can say that there is a certain industrial basis for the pharmaceutical sector in our country, that they have a production capacity far above the needs of the domestic market, and that they are on the threshold of significant growth.
Approximately 53% of the industry consists of international research-based pharmaceutical companies. In addition to these, there are generic drug producers; and since intellectual property rights are not adequately protected in Turkey, there also counterfeit drug producers.
Turkish pharmaceutical industry has exports to over 100 countries. In Turkey, 3.100 types of drugs are being manufactured and because of different dosages and pharmaceutical forms in accordance with the needs of patients’ age groups or the course of the illness, this figure goes up to around 7.200. Drug production, which was around US$ 3.4 billion in 2004, has reached US$ 4.4 million in 2005.
In 2006, drug exports have increased by 11%, and reached around US$ 336 million; whereas imports were US$ 3.2 billion.
In order for the Turkish pharmaceutical industry to accelerate its growth, there needs to be more investments focused on R&D and advanced technology. International investments to be attracted to our country in this area carry a high significance. A Turkey where the investment climate has been improved even further, where transparent and predictable policies are implemented, and where intellectual property rights are protected on an international level shall be stronger and more attractive in this regard. With the implementation of correct long-term strategies, the Turkish pharmaceutical sector shall have a highly competitive industry, and be able to use its potential.
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Question :
What kinds of negative effects might counterfeit drugs have?
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Answer :
Global healthcare authorities mention many cases of mortality and illness due to counterfeit drugs. Fake substances or incomplete therapy may harm individuals because of reasons ranging from unexpected adverse reactions to toxicity or anaphylaxis. These life threatening drugs have caused many deaths in Africa and Asia. Furthermore, if counterfeit drugs enter the legal drug supply chain, safety of the international healthcare system may be compromised, as patients may develop a totally irrational fear against completely safe treatments.
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Question :
Who is the Association of Research-Based Pharmaceutical Companies (AİFD)?
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Answer :
AİFD was founded in 2003 by research-based pharmaceutical companies with operations in Turkey. The Association of Research-Based Pharmaceutical Companies (AİFD) represents 37 multinational pharmaceutical companies.
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Question :
Why are intellectual property rights a priority for you as AİFD?
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Answer :
Because of international property rights not being protected on international standards, Turkey has so far been hindered not just in the pharmaceutical industry, but also in many others. In the past, this was one of the primary reasons why adequate foreign capital did not come to Turkey and permanent investments were not made for years. Recently, our 19th government has taken steps in the right direction. However, there is still a lot to be done in our country in order to achieve international standards in intellectual property rights. Before this process is completed, it is not possible for R&D and production investments in Turkey to increase; nor a fair competition environment to be established. Effective protection of industrial property rights (including patents, commercial brands and all drug registration data) of innovative pharmaceutical products is necessary for high quality healthcare services. Unless patent rights are protected, clinical studies do not advance and many drugs to save patients’ lives may not be found on pharmacy shelves.
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