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A Draft Regulation On The Promotional Activities Of Human Medicinal Products And Food For Special Medical Purposes Has Been Published

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A Draft Regulation On The Promotional Activities Of Human Medicinal Products And Food For Special Medical Purposes Has Been Published

Posted | Updated by Insights team:

Publication | Update:

Jun 2024
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On May 28, 2024, the Turkish Medicines and Medical Devices Agency (“Agency”) published a Draf...

On May 28, 2024, the Turkish Medicines and Medical Devices Agency (“Agency”) published a Draft Regulation on the Promotional Activities of Human Medicinal Products and Food for Special Medical Purposes (“Draft”) on its official website and announced that opinions regarding the Draft can be delivered to the Agency. Significant amendment proposals that differ from the current regulation are as follows:

In General

In addition to physicians, dentists, and pharmacists, promotion activities may also be carried out for dieticians, provided that they are limited to foods for special medical purposes.

Product promotion representatives will also be able to carry out promotional activities via video calls.

The threshold for notifiable value transfers has been reduced by stating that any transfer of value to healthcare professionals or healthcare institutions with a monetary value exceeding 5% of the current gross monthly minimum wage, instead of 10%, shall be notified to the Agency.

The promotion of products that have marketing authorization in Türkiye but are not available in the Turkish market and are authorized by the Agency to be procured from abroad on a prescription basis will only be allowed, provided that it is for pharmacovigilance purposes.

It is foreseen that as of January 2025, marketing authorization holders will be uploading the promotional materials regarding their products that they have prepared or revised before the date of distribution on the electronic database of the Agency. Similarly, marketing authorization holders will be making the notifications of manufacture, import, and distribution of free promotional samples.

Donations, Incentive Ban, Meals

Although it is stated that donations may be made to healthcare institutions in accordance with the legislation, it is emphasized that no payment in-kind and/or in-cash, even under the name of donation or similar names, can be made to health institutions for the entry of product promotion representatives to the establishment. Likewise, it is stated that healthcare professionals and healthcare institutions cannot request incentives from marketing authorization holders or those who carry out promotional activities on their behalf.

It is explicitly regulated that product promotion representatives cannot offer food/beverages, and similar treats to healthcare institution and/or healthcare professionals during their product promotion activities.

Scientific Meetings and Product Promotion Meetings

It is specified that scientific meetings and product promotion meetings can be organized in three different ways: (i) physical meetings, (ii) electronic meetings and (iii) hybrid meetings.

In order to organize scientific meetings and product promotion meetings, regardless of their types, the availability of the relevant products on the Turkish market will be a condition in addition to the condition of being authorized in Türkiye.

Marketing authorization holders will be able to support scientific meetings, electronic scientific meetings, and hybrid scientific meetings held in Türkiye only if the costs of the expense items are charged in Turkish lira.

The initial registrations of scientific meetings must be made by healthcare institutions and marketing authorization holders. Before the initial registration, the scientific program must have been announced by the healthcare institution. After the initial registration, notifications of support can be made until the day before the meeting. Similarly, product promotion meetings can also be organized by making notifications until the day before the meeting.

It is envisaged that after the scientific meetings and product promotion meetings are held, the details of the meetings must be reported in detail via the Agency's electronic system within 60 days at the latest.

Sanctions

The sanctions that can be imposed on the marketing authorization holders are stipulated in a tripartite structure within the context of: (i) infringement of the provisions regarding scientific meetings and product promotion meetings in general, regardless of the type; (ii) infringement of other provisions; (iii) infringement of the regulation by the employees or product promotion representatives operating promotional activities. It is stipulated that administrative sanctions, which typically begin with a warning, to include a 1 month - 3 months - 6 months - 1 year ban from engaging in promotional activities by gradation based on repetition of the infringements within 1-year periods. Furthermore, it is foreseen that the sanctions imposed on the marketing authorization holders to be published on the Agency's website.

In terms of infringing acts of product promotion representatives, it is stipulated that the administrative sanctions to follow a similar pattern, beginning with a warning and following with the suspension of the qualification certificate for 1 month - 3 months - 6 months - 1 year by gradation based on the repetition of the infringing acts within 1-year periods.

The administrative sanctions for healthcare professionals in terms of the infringement of the provisions regarding scientific meetings and product promotion meetings in general, regardless of the type, start with a warning in line with a similar system, and follow with not being provided with the sponsorship of marketing authorization holders directly or indirectly for 1 month - 3 months - 6 months - 1 year by gradation based on repetition of the infringing acts within 1 year periods.

In addition, disciplinary actions may be initiated before the relevant institution or professional organization for all infringements by healthcare professionals and healthcare institutions within the scope of the Draft.

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This study has assimilated knowledge and insight from business and subject-matter experts, and from a broad spectrum of market initiatives. Building on this research, the objectives of this market research report is to provide actionable intelligence on opportunities alongside the market size of various segments, as well as fact-based information on key factors influencing the market- growth drivers, industry-specific challenges and other critical issues in terms of detailed analysis and impact.

The report in its entirety provides a comprehensive overview of the current global condition, as well as notable opportunities and challenges. The analysis reflects market size, latest trends, growth drivers, threats, opportunities, as well as key market segments. The study addresses market dynamics in several geographic segments along with market analysis for the current market environment and future scenario over the forecast period. The report also segments the market into various categories based on the product, end user, application, type, and region.
The report also studies various growth drivers and restraints impacting the  market, plus a comprehensive market and vendor landscape in addition to a SWOT analysis of the key players.  This analysis also examines the competitive landscape within each market. Market factors are assessed by examining barriers to entry and market opportunities. Strategies adopted by key players including recent developments, new product launches, merger and acquisitions, and other insightful updates are provided.

Research Process & Methodology

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We leverage extensive primary research, our contact database, knowledge of companies and industry relationships, patent and academic journal searches, and Institutes and University associate links to frame a strong visibility in the markets and technologies we cover.

We draw on available data sources and methods to profile developments. We use computerised data mining methods and analytical techniques, including cluster and regression modelling, to identify patterns from publicly available online information on enterprise web sites.
Historical, qualitative and quantitative information is obtained principally from confidential and proprietary sources, professional network, annual reports, investor relationship presentations, and expert interviews, about key factors, such as recent trends in industry performance and identify factors underlying those trends - drivers, restraints, opportunities, and challenges influencing the growth of the market, for both, the supply and demand sides.
In addition to our own desk research, various secondary sources, such as Hoovers, Dun & Bradstreet, Bloomberg BusinessWeek, Statista, are referred to identify key players in the industry, supply chain and market size, percentage shares, splits, and breakdowns into segments and subsegments with respect to individual growth trends, prospects, and contribution to the total market.

Research Portfolio Sources:

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Forecast methodology

The future outlook “forecast” is based on a set of statistical methods such as regression analysis, industry specific drivers as well as analyst evaluations, as well as analysis of the trends that influence economic outcomes and business decision making.
The Global Economic Model is covering the political environment, the macroeconomic environment, market opportunities, policy towards free enterprise and competition, policy towards foreign investment, foreign trade and exchange controls, taxes, financing, the labour market and infrastructure. We aim update our market forecast to include the latest market developments and trends.

Forecasts, Data modelling and indicator normalisation

Review of independent forecasts for the main macroeconomic variables by the following organizations provide a holistic overview of the range of alternative opinions:

  • Cambridge Econometrics (CE)

  • The Centre for Economic and Business Research (CEBR)

  • Experian Economics (EE)

  • Oxford Economics (OE)

As a result, the reported forecasts derive from different forecasters and may not represent the view of any one forecaster over the whole of the forecast period. These projections provide an indication of what is, in our view most likely to happen, not what it will definitely happen.

Short- and medium-term forecasts are based on a “demand-side” forecasting framework, under the assumption that supply adjusts to meet demand either directly through changes in output or through the depletion of inventories.
Long-term projections rely on a supply-side framework, in which output is determined by the availability of labour and capital equipment and the growth in productivity.
Long-term growth prospects, are impacted by factors including the workforce capabilities, the openness of the economy to trade, the legal framework, fiscal policy, the degree of government regulation.

Direct contribution to GDP
The method for calculating the direct contribution of an industry to GDP, is to measure its ‘gross value added’ (GVA); that is, to calculate the difference between the industry’s total pre­tax revenue and its total bought­in costs (costs excluding wages and salaries).

Forecasts of GDP growth: GDP = CN+IN+GS+NEX

GDP growth estimates take into account:

  • Consumption, expressed as a function of income, wealth, prices and interest rates;

  • Investment as a function of the return on capital and changes in capacity utilization; Government spending as a function of intervention initiatives and state of the economy;

  • Net exports as a function of global economic conditions.

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Market Quantification
All relevant markets are quantified utilizing revenue figures for the forecast period. The Compound Annual Growth Rate (CAGR) within each segment is used to measure growth and to extrapolate data when figures are not publicly available.

Revenues

Our market segments reflect major categories and subcategories of the global market, followed by an analysis of statistical data covering national spending and international trade relations and patterns. Market values reflect revenues paid by the final customer / end user to vendors and service providers either directly or through distribution channels, excluding VAT. Local currencies are converted to USD using the yearly average exchange rates of local currencies to the USD for the respective year as provided by the IMF World Economic Outlook Database.

Industry Life Cycle Market Phase

Market phase is determined using factors in the Industry Life Cycle model. The adapted market phase definitions are as follows:

  • Nascent: New market need not yet determined; growth begins increasing toward end of cycle

  • Growth: Growth trajectory picks up; high growth rates

  • Mature: Typically fewer firms than growth phase, as dominant solutions continue to capture the majority of market share and market consolidation occurs, displaying lower growth rates that are typically on par with the general economy

  • Decline: Further market consolidation, rapidly declining growth rates

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The Global Economic Model
The Global Economic Model brings together macroeconomic and sectoral forecasts for quantifying the key relationships.

The model is a hybrid statistical model that uses macroeconomic variables and inter-industry linkages to forecast sectoral output. The model is used to forecast not just output, but prices, wages, employment and investment. The principal variables driving the industry model are the components of final demand, which directly or indirectly determine the demand facing each industry. However, other macroeconomic assumptions — in particular exchange rates, as well as world commodity prices — also enter into the equation, as well as other industry specific factors that have been or are expected to impact.

  • Vector Auto Regression (VAR) statistical models capturing the linear interdependencies among multiple time series, are best used for short-term forecasting, whereby shocks to demand will generate economic cycles that can be influenced by fiscal and monetary policy.

  • Dynamic-Stochastic Equilibrium (DSE) models replicate the behaviour of the economy by analyzing the interaction of economic variables, whereby output is determined by supply side factors, such as investment, demographics, labour participation and productivity.

  • Dynamic Econometric Error Correction (DEEC) modelling combines VAR and DSE models by estimating the speed at which a dependent variable returns to its equilibrium after a shock, as well as assessing the impact of a company, industry, new technology, regulation, or market change. DEEC modelling is best suited for forecasting.

Forecasts of GDP growth per capita based on these factors can then be combined with demographic projections to give forecasts for overall GDP growth.
Wherever possible, publicly available data from official sources are used for the latest available year. Qualitative indicators are normalised (on the basis of: Normalised x = (x - Min(x)) / (Max(x) - Min(x)) where Min(x) and Max(x) are, the lowest and highest values for any given indicator respectively) and then aggregated across categories to enable an overall comparison. The normalised value is then transformed into a positive number on a scale of 0 to 100. The weighting assigned to each indicator can be changed to reflect different assumptions about their relative importance.

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The principal explanatory variable in each industry’s output equation is the Total Demand variable, encompassing exogenous macroeconomic assumptions, consumer spending and investment, and intermediate demand for goods and services by sectors of the economy for use as inputs in the production of their own goods and services.

Elasticities
Elasticity measures the response of one economic variable to a change in another economic variable, whether the good or service is demanded as an input into a final product or whether it is the final product, and provides insight into the proportional impact of different economic actions and policy decisions.
Demand elasticities measure the change in the quantity demanded of a particular good or service as a result of changes to other economic variables, such as its own price, the price of competing or complementary goods and services, income levels, taxes.
Demand elasticities can be influenced by several factors. Each of these factors, along with the specific characteristics of the product, will interact to determine its overall responsiveness of demand to changes in prices and incomes.
The individual characteristics of a good or service will have an impact, but there are also a number of general factors that will typically affect the sensitivity of demand, such as the availability of substitutes, whereby the elasticity is typically higher the greater the number of available substitutes, as consumers can easily switch between different products.
The degree of necessity. Luxury products and habit forming ones, typically have a higher elasticity.
Proportion of the budget consumed by the item. Products that consume a large portion of the consumer’s budget tend to have greater elasticity.
Elasticities tend to be greater over the long run because consumers have more time to adjust their behaviour.
Finally, if the product or service is an input into a final product then the price elasticity will depend on the price elasticity of the final product, its cost share in the production costs, and the availability of substitutes for that good or service.

Prices
Prices are also forecast using an input-output framework. Input costs have two components; labour costs are driven by wages, while intermediate costs are computed as an input-output weighted aggregate of input sectors’ prices. Employment is a function of output and real sectoral wages, that are forecast as a function of whole economy growth in wages. Investment is forecast as a function of output and aggregate level business investment.

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