Medicinal products

A medicinal product consists of the active substance(s) and excipients. The active substance treats or alleviates the disease, while excipients are necessary in the medicinal product to enable the active substance to be administered in the desired form (e.g. tablet, ointment, aerosol). As it is the active substance that affects the body, the adverse reactions of a medicinal product are also caused by the active substance. Excipients do not cause adverse reactions, except in very exceptional cases where a person is hypersensitive to a particular excipient (lactose, nut oils, various sugars). As a rule, manufacturers of both the originator and generic medicinal products use the same or similar excipients. Excipients authorised for use in the formulation of medicinal products must be of high quality and must be shown to be safe for the intended route of administration. An excipient authorised in a medicinal product must not adversely affect the properties of the medicinal product.

A generic medicinal product (alternatively also known as an analogue medicinal product) is a medicinal product that contains the same active substance as the originator medicinal product and is meant for the treatment of the same diseases. A generic medicinal product is as effective and safe as the originator medicinal product, and of the same quality. Generic medicinal products are placed on the market after the patent protection of the originator medicinal product expires. This means that a medicinal product with the same active ingredient can also be produced by other manufacturers. The manufacturer of a generic medicinal product has to demonstrate that the medicinal product contains the same active substance in exactly the same amount as the originator medicinal product and has an identical effect on the organism as the originator medicinal product. The latter is demonstrated using bioequivalence studies, i.e. studies carried out to determine whether the same amount of the active substance is taken up by the organism from both the originator and the generic medicinal product, and whether the concentration of the active substance in the organism changes in an identical manner over time in both cases.

Bioequivalent medicinal products provide an identical concentration of the active substance in the organism as the originator medicinal products when administered in identical doses. The manufacturer of the generic medicinal product also has to demonstrate that the manufacturing process of the medicinal product meets the established criteria.

Given that it is produced by another pharmaceutical manufacturer, the appearance of the medicinal product is not required to be identical to the original medicinal product. The generic medicinal product may thus differ from the originator medicinal product in terms of excipients and appearance, but must be identical to the originator in terms of efficacy, quality, and safety.

Estonian pharmacies only sell medicinal products that have passed the strict control of the Estonian State Agency of Medicines.

When the patent period of the originator medicinal product expires, other pharmaceutical companies will start producing a medicinal product with the same active substance, and the price of the medicinal product will be determined by competition between pharmaceutical companies. However, the manufacturer of the originator medicinal product can recoup the money spent on developing the medicinal product during the validity of the patent and thus maintain interest in further development. It may happen that, after the end of the patent period, the manufacturer of the medicinal product lowers the price of the medicinal product to the same level as those of generic medicinal products.

In the pharmaceutical world, more expensive does not always mean better when it comes to the quality of medicinal products containing the same active substance. Generic medicinal products are of the same quality, efficacy, and safety as originator medicinal products, so it makes economic sense to choose the cheapest products. In Estonia, a pharmacist is obliged to offer the person the most favourable alternative in the case of equal choices, provided that the doctor has not ordered the person to buy the medicinal product from a specific manufacturer. If the doctor has written the active substance on the prescription (an ‘active substance based-prescription’), the person can choose the medicinal product that best suits their needs from a range of equivalent alternatives. There is no medical reason to prefer a more expensive medicinal product.

No. In the pharmaceutical world, more expensive does not always mean better when it comes to the quality of medicinal products containing the same active substance. Generic medicinal products are of the same quality, efficacy, and safety as originator medicinal products. Preference for or exclusion of a particular manufacturer for medical reasons is rare (e.g. hypersensitivity to a particular excipient, see also question 1). People usually prefer a particular manufacturer due to psychological reasons or the marketing strategies of that manufacturer.

There is no reason to assume that pregnant people should use originator medicinal products instead of generic medicinal products. The choice of medicinal products should be based on the active substance (whether the pregnant person is indicated to use one active substance or another), rather than on the basis of a specific manufacturer.

No, definitely not. The dosage of a medicinal product is determined independently of whether it is a generic or originator medicinal product. Generic medicinal products are of the same quality, efficacy, and safety as originator medicinal products. The dose of the medicinal product is determined by the disease, the active substance used, and the patient. In addition to the doctor and pharmacist, the patient can also get information on the dosage of a particular medicinal product from the patient information leaflet.

Yes. In medical terms, a generic medicinal product is exactly the same as the originator medicinal product. Generic medicinal products are of the same quality, efficacy, and safety as originator medicinal products, so there is no need to change the dose of the medicinal product or the treatment regimen if you have switched from one medicinal product to another containing the same active substance.

Regardless of whether the person buys a generic or an originator medicinal product, the reimbursement rate of the Health Insurance Fund (50%, 75%, 90%, or 100%) remains the same. As Estonia has a limit price system for medicinal products containing the same active substance, the choice of medicinal product only affects the co-payment a person has to pay.

For example, if a pharmacy has a selection of medicinal products with the same active substance at a price of 6.39 euros, 9.59 euros, 11.19 euros, and 12.78 euros, then the limit price will generally be the price of the second most affordable medicinal product (9.59 euros in this example) and the benefit percentage of the Health Insurance Fund will be calculated from this amount. If the person prefers a more expensive medicinal product, in addition to the co-payment (3.5 euros), they will also have to pay the excess amount in terms of the price limit. It is therefore worth asking your pharmacist for advice on which medicinal product with the same active substance is cheaper.

The price the person has to pay depends on which medicinal product they buy.

For example, with a 75% benefit, the person pays:

• 4.22 euros for the purchase of a medicinal product costing 6.39 euros (3.5-euro co-payment for each prescription + 0.72 euros, i.e. 25% of 2.89 euros*).
• 5.02 euros for the purchase of a medicinal product costing 9.59 euros (3.5-euro co-payment for each prescription + 1.52 euros, i.e. 25% of 6.09 euros*).
• 6.62 euros for the purchase of a medicinal product costing 11.19 euros (3.5-euro co-payment for each prescription + 1.52 euros, i.e. 25% of 6.09 euros** + 1.6 euros (amount exceeding the price limit)).
• 8.21 euros for the purchase of a medicinal product costing 12.78 euros (3.5-euro co-payment for each prescription + 1.52 euros, i.e. 25% of 6.09 euros** + 3.19 euros (amount exceeding the price limit)).

100% benefit – the person pays a co-payment of 3.5 euros and the amount exceeding the price limit or the price in the price agreement. The Health Insurance Fund will reimburse 100% of the difference between the price limit or the price agreement and the co-payment.

• Example 1:

the person was given a reimbursable prescription for a medicinal product which costs 10 euros. The price limit of the active substance is set at 8 euros. The discounted price for the person consists of:

- the person’s co-payment: 3.5 euros

- the amount exceeding the price limit: 10 euros – 8 euros = 2 euros

- the Health Insurance Fund reimburses 100% of the difference between the price limit or the price agreement and the co-payment.

The person has to pay 3.5 euros + 2 euros = 5.5 euros for the medicinal product.

90% benefit – the person pays a co-payment of 3.5 euros, 10% of the difference between the price limit or the price agreement and the co-payment, and the amount exceeding the price limit or the price agreement. The Health Insurance Fund will reimburse 90% of the difference between the price limit or the price agreement and the co-payment.

• Example 2:

the person was given a reimbursable prescription for two medicinal products which cost 10 euros. The price limit of the active substance is set at 8 euros.

The discounted price for the person consists of:

- the person’s co-payment: 3.5 euros

- the amount exceeding the price limit: 10 euros – 8 euros = 2 euros, 2 euros × 2 products = 4 euros

- the Health Insurance Fund reimburses 90% of the difference between the price limit or the price agreement and the co-payment, so the person’s share (10%) is (8 euros × 2 products – 3.5 euros) × 10% = 1.25 euros

The person has to pay 3.5+ 4 euros + 1.25 euros = 8.75 euros for the medicinal products.

75% benefit – the person pays a co-payment of 3.5 euros, 25% of the difference between the price limit or the price agreement and the co-payment, and the amount exceeding the price limit or the price agreement. The Health Insurance Fund will reimburse 75% of the difference between the price limit or the price agreement and the co-payment.

• Example 3:

the person was given a reimbursable prescription for a medicinal product which costs 10 euros. The price limit of the active substance is set at 8 euros. The discounted price for the person consists of:

- the person’s co-payment: 3.5 euros

- the amount exceeding the price limit: 10 euros – 8 euros = 2 euros

- the Health Insurance Fund reimburses 75% of the difference between the price limit or the price agreement and the co-payment, so the person’s share (25%) is (8 euros – 3.5 euros) × 25% = 1.13 euros.

The person has to pay 3.5 euros + 2 euros + 1.12 euros = 6.63 euros for the medicinal product.

50% benefit – the person pays a co-payment of 3.5 euros, 50% of the difference between the price limit or the price agreement and the co-payment, and the amount exceeding the price limit or the price agreement. The Health Insurance Fund will reimburse 50% of the difference between the price limit or the price agreement and the co-payment.

• Example 4:

the person was given a reimbursable prescription for a medicinal product which costs 40 euros. The price limit of the active substance is set at 35 euros. The discounted price for the person consists of:

- the person’s co-payment: 3.5 euros

- the amount exceeding the price limit: 40 euros – 35 euros = 5 euros

- the Health Insurance Fund reimburses 50% of the difference between the price limit or the price agreement and the co-payment, so the person’s share (50%) is (35 euros – 3.5 euros) × 50% = 15.75 euros.

Yes, people who do not have health insurance have to pay the full price of the prescribed medicinal products.

For the exceptional reimbursement of medicinal products, the insured person or their legal representative must submit a free-form application to the Health Insurance Fund, which must contain the following information about the applicant:

1. First and last name.

2. Personal identification code.

3. Contact information (residential address, phone number, email residential address).

The application must be accompanied by the justification from the doctor. These documents must be submitted to the Health Insurance Fund by email (info [at] tervisekassa.ee (info[at]tervisekassa[dot]ee)), by post, or by submitting them in person.

The decision on exceptional compensation is taken by the management of the Health Insurance Fund. An extract from the decision will be sent to the patient and their doctor. The person can buy the medicinal product from a pharmacy on the basis of a prescription written by the doctor after a positive decision by the board of the Health Insurance Fund to exceptionally reimburse the medicinal product.

Yes. If the patient has no contraindications to childbirth, the benefit rate for the pills is 50%.

If an insured person has bought more than 100 euros’ worth of medicinal products (with the benefit) in a year, they will receive an supplementary benefit for medicinal products. The supplementary benefit will be applied automatically, meaning that the person does not have to submit an application to the Health Insurance Fund.

If a person has bought medicinal products (with the benefit):

- for 100–300 euros per year, the Health Insurance Fund will reimburse 50% of the amount exceeding 100 euros (maximum 100 euros per year).

- for more than 300 euros a year, the Health Insurance Fund will reimburse 90% of the amount exceeding 300 euros.

The Health Insurance Fund reimburses the cost of prescription medicinal products purchased in the European Union. First, you have to buy the medicinal product and then you can apply for a refund from the Health Insurance Fund. To do this, you must fill in the application (Application for reimbursement of the cost of healthcare in the European Union, in Estonian) on the website of the Health Insurance Fund and attach the original prescriptions and the receipts proving payment. The documents can be sent to the Health Insurance Fund by post or taken to its client service offices.

The Health Insurance Fund will make an inquiry in the foreign country and, based on the information received, transfer the amount to be reimbursed in euros to the bank account of the person.