Bulgaria
Products containing estrogen
Standpoint of market research in the Central-Eastern European countries

SOFIA, BULGARIA


Budgetary Quotation

QUO-MedCon-04 / 20.02.2006

Chemo S.A. was founded in 1977. Chemo is engaged in the production and distribution of pharmaceutical and veterinary raw materials as well as intermediate products and other fine chemicals. In the last years Chemo started its activities in the finished product field with the production of controlled-release pellets, developing afterwards a broad portfolio of generics.
In all Chemo activities they make’s a significant effort in research and development.





The “Scope of Work” shall consist of the following marketing research activities, in accordance with the requirements of CHEMO as following:


General aspects

• How many residents are there in the country? What national minorities are there and in what ratio?
• What is the distribution of the population by age? What is the annual number of births/deaths?
• How many percent of the population is capable to work and how many of them are active workers (male/female)?
• What economical growth has the country shown in the past 10 years?
• How much is the average income? To what degree is the population polarized in respect of incomes?
• How has the real income formed in the last 10 years?
• How many adult (18-45 ys) fertile women are in the country?
• How many women in menopause (>45 ys) are in the country?

The drug market

• What size is the whole drug market? How has it changed in the last 10 years?
• What is the ratio between the prescription-only market and the OTC market?
• Which are the market leader companies?
• How large is the segment of the drug market that is subject to reimbursement? How large is the budget for reimbursement per year? What’s the trend?
• What is the average percentage of the retail price reimbursed? What are the typical/usual percentage for certain medicinal products and ATC product groups?
• What is the price structure? (manufacturer’s price – wholesaler’s margin – pharmacists’ margin)
• On what basis are drugs being given prices? Is there any price negotiation?
• How frequent are new products being given prices? How frequent/how fast is the official acceptance and declaration/publishing of these?
• What is the limiting price that consumers are willing to pay for acute and chronic drugs?
• How many active specialists and GPs are in the country?
• What are the most important elements of promotion in the pharmaceutical market?
• How many sales representatives working for pharmaceutical manufacturers are in the country? What are the requirements towards them (qualification)?
• How many pharmacies are in the country?
• What regulations do exist regarding advertising/giving information about drugs for specialists as well as incompetent patients?
• Which are the drug wholesalers distributing all over the country?

Estrogen market

• How big is the contraceptive and hormone-substitute market (number of patients, manufacturer price, growth for the last 5 years)?
• Data about the competitor products (active substance, manufacturer, date of introduction, unit price (manufacturer’s & consumer’s, monthly cost of therapy, turnover: sales at manufacturer price, number of patients, market share (%), original or generic).
• Who is the market leader? (what other products do they distribute, how many percent is the product’s share from the total turnover, what kind of promotion is applied, how this company is judged by prescribers?)
• Has the oral market and the opinion of doctors’ changed according to the professional debate over hormone-substitutes in the last 12 months?

Regulation – hormonal products

• Are these products concerned/classified as drugs?
• Are they prescription-only or not?
• Which specialists are allowed to prescribe them?
• Are they subjects to reimbursement, if so, by what extent and what way?
• Can any change in regulation be expected in the near future?
• How can these products be promoted for specialists as well as incompetent patients?
• Are there any restrictions?

Registration

• Who is responsible for registration (names, availabilities)?
• What documents are needed? Are there any national requirements?
• How long does a registration take?
• How frequent are new products announced? Are announcements predictable and regular?
• Are there regulations for announcement or does it happen by occasional decisions?
• Do the authorities accept MRP files compatible to EU?
• In case of a product subject to reimbursement how long does the granting procedure takes?
• On what basis are products being granted reimbursement? What factors the reimbursement percentage depends on?
• Is there any official/unofficial protection over domestic manufacturers in the country, if so, to what degree? How effective is the pharmaceutical lobbying?
• Under what patent protection innovative products are? (Are there valid legislation rules and/or international agreements to comply with, do all even adhere to them?)
• Does data exclusivity protection exist in the country?
• Are there national and/or international patents legally effective?

Gynaecologists

• How many active gynaecologists are in the country?
• Which are the features and components of the ideal contraceptive/hormone-substitute by their judgement? Are there any product meeting these requirements? Which are they?
• What are the 3 best features of the product they recommend?
• Which one do they prescribe most frequently and why?
• Which ones they wouldn’t ever prescribe and why?
• Are there any accepted (or other competent) guidelines of some professional council/advisory board? Do these influence doctors in choosing therapy?
• What are the most important aspects of choosing product?
• Is there any „Key Opinion Leader” team in the country whose opinion influences the therapeutic manners indeed?
• What is the judgement about generic manufacturers and products?

Women

• Are there any obstacles (religion, social, ethnical) of using contraceptives and hormone substitutes? If so, to what extent the population may be affected?
• Are there any other popular ways of contraception, if so, what are they? How many percent of women apply these?
• How many percent of women use hormonal contraceptives? What is the proportional turnover of permanent and ad hoc contraceptives?
• Is there any preferred contraceptive among women? If so, why?
• Whose opinion influences women in taking/choosing contraceptives?
• Do women have contraceptives prescribed only by gynaecologists in every case?

BUDGETARY QUOTATION

1	Review, contracting and starting up of marketing analysis	(50%)
2	Draft of marketing analysis	(40%)
3	Revision and guarantee for good execution	(10%)
Total budgetary quotation:		VAT Excluded

CONCLUSION

We would be very pleased to be awarded with this project. The management in charge of Chemo S.A. can be assured that Medconsult Ltd. will put all effort in the development of this task.
We are always at your disposal for any questions or comments.


Sofia, 20.02.06




General Manager
Medconsult Ltd.